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The Medicines Act (Act No. Iii Of 2003)

ACT No. III of 2003

AN ACT enacted by the Parliament of

Malta.

AN ACT to make provision for matters connected with the manufacture, preparation and assembly, wholesale distribution, storage, destruction, disposal, advertising and authorisation of medical products and any activity connected therewith and the regulation of the sale of medicinal products, pharmacies and related pharmaceutical activities and for any other matters ancillary thereto or connected therewith.

A 135
ATT TA’ L-2003 DWAR IL-MEDI¬INI Arran[ament ta’ l-artikoli
1. Titolu fil-qosor u bidu fis-se]]
TAQSIMA I - PRELIMINARI
2. Tifsir
TAQSIMA II - AMMINISTRAZZJONI

TITOLU I - Awtorità dwar il-Li`enzjar

3. Funzjonijiet ta’ l-Awtorità dwar il-Li`enzjar

TITOLU II - L-Awtorità dwar il-Medi`ini

4. Twaqqif ta’ l-Awtorità dwar il-Medi`ini
5. Personalità [uridika ta’ l-Awtorità
6. Funzjonijiet ta’ l-Awtorità dwar il-Medi`ini
7. Organizzazzjoni ta’ l-Awtorità dwar il-Medi`ini
8. L-Uffi`jal E\ekuttiv Ewlieni ta’ l-Awtorità dwar il-Medi`ini
9. Impjegati ta’ l-Awtorità dwar il-Medi`ini
10. Kontijiet ta’ l-Awtorità dwar il-Medi`ini
11. Akkwisti mill-Awtorità
12. Kif japplika l-Kodi`i ta’ Etika
13. E\enzjoni mit-taxxa, e``

TITOLU III - Bord ta’ Revi\joni dwar il-Medi`ini

14. Twaqqif ta’ Bord ta’ Revi\joni dwar il-Medi`ini
15. Bord ta’ Revi\joni dwar il-Medi`ini jista’ ja]tar konsulenti
16. Funzjonijiet tal-Bord ta’ Revi\joni dwar il-Medi`ini
17. Pro`edura dwar l-appelli
18. Smig] fil-pubbliku
A 136
TAQSIMA III - DISPOSIZZJONIJIET {ENERALI

TITOLU I - Awtorizzazzjoni g]at-Tqeg]id fis-Suq Ta' Prodotti Medi`i

19. Kif japplikaw `erti disposizzjonijiet
20. Awtorizzazzjoni biex jitqieg]du prodotti medi`inali fis-suq
21. Revi\joni jew appell
22. G]oti ta’ awtorizzazzjoni ta’ tqeg]id fis-suq
23. Notifikazzjoni ta’ awtorizzazzjoni ta’ tqeg]id fis-suq
24. Validità ta’ awtorizzazzjoni ta’ tqeg]id fis-suq
25. Applikazzjoni g]al ti[did
26. Notifikazzjoni ta’ rifjut ta’ ti[did
27. Meta awtorizzazzjoni ta’ tqeg]id fis-suq ma ti[[eddidx
28. Sospensjoni jew revoka ta’ awtorizzazzjoni ta’ tqeg]id fis-suq
29. Klassifikazzjoni ta’ prodotti medi`inali
30. Lista ta’ medi`ini li g]andhom awtorizzazzjoni ta’ tqeg]id fis-suq
31. Reklamar ta’ prodotti medi`inali
32. Prodotti medi`inali omeopati`i
33. Prodotti li jinkisbu mid-demm tal-bniedem jew plasma tal-bniedem
34. Prodotti medi`inali radjofarma`ewti`i
35. Prodotti medi`inali immunolo[i`i
36. Prodotti medi`inali erbali

TITOLU II - Manifattura ta’ Prodotti Medi`inali g]all-U\u tal-Bniedem

37. Li`enza ta’ manifattur
38. Applikazzjoni g]al Li`enza ta’ manifattur
39. G]oti ta’ li`enza ta’ manifattur
40. Avvi\ dwar informazzjoni ulterjuri
A 137
41. Sospensjoni jew revoka ta’ li`enza ta’ manifattur
42. Spezzjoni fir-rigward ta’ manifattur, e``
43. G]al kemm \mien iddum u ti[did ta’ li`enza ta’ manifattur, e``
44. Responsabbiltajiet ta’ detentur ta’ li`enza ta’ manifattur
45. Responsabbiltajiet tal-persuna kwalifikata
46. Sospensjoni ta’ attività ta’ persuna kwalifikata
47. Bdil fil-kondizzjonijiet ta’ li`enza ta’ manifattur
48. Obbligi ta’ l-Awtorità dwar il-Li`enzjar
49. Manifattura ta’ prodotti medi`inali omeopati`i
50. Manifattura ta’ prodotti medi`inali li jinkisbu mid-demm tal-bniedem u plasma tal-bniedem
51. Manifattura ta’ radjofarma`ewti`i
52. Prodotti medi`inali immunolo[i`i
53. Prodotti medi`inali erbali

TITOLU III - Distribuzzjoni bl-Ingrossa ta’ Prodotti Medi`inali g]all-U\u tal-Bniedem

54. Negozju bl-ingrossa
55. Applikazzjoni g]al li`enza ta’ negozjant bl-ingrossa
56. G]oti ta’ li`enza ta’ negozjant bl-ingrossa
57. Avvi\ dwar informazzjoni ulterjuri
58. G]al kemm \mien iddum u ti[did ta’ li`enza ta’ negozjant bl-ingrossa
59. Obbligi ta’ detentur ta’ li`enza ta’ negozjant bl-ingrossa
60. Ir-responsabbiltà li g]andhom il-persuni responsabbli
61. Sospensjoni jew revoka ta’ li`enza ta’ negozjant bl-ingrossa
62. Bdil fil-kondizzjonijiet ta’ li`enza ta’ negozjant bl-ingrossa
63. Obbligi ta’ l-Awtorità dwar il-Li`enzjar
A 138
64. Spezzjonar dwar bejg] bl-ingrossa
65. Disposizzjonijiet spe`jali

TITOLU IV - Spi\eriji u Attività Farma`ewtika relatata

66. Li`enza biex tinfeta] spi\erija
67. Applikazzjoni g]al li`enza ta’ spi\erija
68. G]oti ta’ li`enza ta’ spi\erija
69. Avvi\ dwar informazzjoni ulterjuri
70. G]al kemm \mien iddum u ti[did ta’ li`enza ta’ spi\erija
71. Trasferiment ta’ li`enza ta’ spi\erija
72. Sospensjoni jew revoka ta’ li`enza ta’ spi\erija
73. G]eluq temporanju ta’ spi\erija
74. Obbligi ta’ detentur ta’ li`enza ta’ spi\erija
75. Spi\jar responsabbli
76. Prodotti medi`inali jinbieg]u minn spi\erija
76. Dmirijiet ta’ spi\jar
77. Interess fi spi\erija
78. Detentur ta’ li`enza jista’ jimpjega spi\jar wie]ed jew aktar
79. Prodotti medi`inali li g]andhom jinbieg]u minn spi\erija
80. Bejg] ta’ prodotti medi`inali
81. Bejg] b’ri`etta
82. Meta ti[i ppre\entata ri`etta
83. Ittikkettjar ta’ prodotti mibjug]a
84. Bejg] ta’ prodotti skaduti, mg]arrqa jew mhux perfetti
85. }\in ta’ prodotti medi`inali fi spi\erija
86. Il-fond, e`` skond il-]ti[iet u standards
A 139
87. L-ispi\jar g]andu jimxi skond standards stabbiliti
88. Spezzjoni ta’ spi\eriji
89. Ftu] ta’ spi\eriji
TAQSIMA IV - SUSTANZI VELENU|I
90. Tifsira ta’ veleni
91. Ti\mim e`` ta’ veleni
92. Li`enza g]all-bejg] ta’ veleni
93. Ti\mim ta’ sustanzi velenu\i f’post sigur
94. Bejg] ta’ sustanzi velenu\i
95. Setg]a ta’ spezzjon
96. Qmu], \rierag] e``., ivvelenati
TAQSIMA V - MOD IE}OR KIF JI{U TTRATTATI PRODOTTI MEDICINALI
97. Restrizzjonijiet spe`jali fuq persuni li ji[u fornuti bi prodotti medi`inali
98. Adulterazzjoni ta’ prodotti medi`inali
TAQSIMA VI - REATI U PIENI
99. Reati u pieni
100. Pro`edura spe`jali
TAQSIMA VII - INFURZAR
101. Dritt ta’ d]ul
102. Setg]a li tispezzjona, tie]u kampjuni u taqbad merkanzija u dokumenti
103. Kif tapplika pro`edura ta’ te]id ta’ kampjuni dwar sustanza jew o[[ett elevat
104. Disposizzjonijiet supplimentari dwar drittijiet ta’ d]ul
TAQSIMA VIII - DISPOSIZZJONIJIET MIXXELLANJI
105. G]arfien ta’ standards ekwivalenti
106. Setg]a tal-Ministru li jag]mel regolamenti
A 140
107. Disposizzjoni transitorja
108. Emendi g]all-Ordinanza dwar il-Professjoni Medika u l-Professjonijiet li g]andhom x’jaqsmu mag]ha
109. Riserva
L-Ewwel Skeda - Panel ta’ esperti biex joqog]du fil-Bord ta’ Revi\joni dwar il-Medi`ini
It-Tieni Skeda - Pro`edimenti tal-Bord ta’ Revi\joni dwar il-Medi`ini
It-Tielet Skeda - Kondizzjonijiet u kriterji li jistabbilixxu jekk persuna g]andha jew m’g]andhiex interess dirett jew indirett fi spi\erija
A 141
Nag]ti l-kunsens tieg]i.
(L.S.) GUIDO DE MARCO
President
5 ta’ Marzu, 2003

ATT Nru. III ta’ l-2003

ATT biex jipprovdi dwar ]wejje[ li ghandhom x’jaqsmu mal- manifattura, l-preparazzjoni u l-assembla[[, id-distribuzzjoni bl- ingrossa, il-]\in, il-qirda, t-tne]]ija, r-reklamar u l-awtorizzazzjoni ta’ prodotti medicinali u ta’ kull attività li ghandha x’taqsam ma’ dan u r-regolament tal-bejgh ta’ prodotti medicinali, spi\eriji u attivitajiet farma`ewtici relatati u dwar ]wejje[ o]ra an`illari ghal dawn jew li ghandhom x’jaqsmu mag]hom.

IL-PRESIDENT bil-parir u l-kunsens tal-Kamra tad-Deputati, imlaqqg]a f’dan il-Parlament, u bl-awtorità ta’ l-istess, ]are[ b’li[i dan li [ej:-

1. (1) It-titolu fil-qosor ta’ dan l-Att huwa l-Att ta’ l-2003 dwar il-Medi`ini.

(2) Dan l-Att jibda jse]] f’dik id-data li l-Ministru responsabbli mis-sa]]a jista’ b’avvi\ fil-Gazzetta jistabbilixxi, u dati differenti jistg]u ji[u hekk stabbiliti g]al disposizzjonijiet differenti jew g]al g]anijiet differenti ta’ dan l-Att.

TAQSIMA I

PRELIMINARI

2. F’dan l-Att, kemm-il darba r-rabta tal-kliem ma tkunx te]tie[ xort’o]ra -

''analisi'' tinkludi l-ittestjar ta’ xi prodott medi`inali jew ta’ xi kostitwenti tieg]u, kemm attivi kemm mhux attivi, dwar il- proprjetajiet kimi`i, fi\i`i, farma`ewti`i, biolo[i`i, tossikolo[i`i jew farmakolo[i`i tag]hom;

Titolu fil-qosor u bidu fis-se]].

Tifsir.

A 142
''apparat mediku'' tfisser strument, apparat, tag]mir, materjal jew xi o[[ett ie]or, sew jekk u\at wa]du jew f’kombinazzjoni, inklu\ kull software me]tie[ g]all-applikazzjoni tieg]u adatta kif inti\a mill-manifattur li jkun u\at g]all-bnedmin g]all-fini ta’:
(a) dijanjosi, prevenzjoni, sorveljar, kura jew allevjazzjoni ta’ marda;
(b) dijanjosi, sorveljar, kura, allevjazzjoni jew kumpens g]al feriment jew di\abilità;
(`) investigazzjoni, sostituzzjoni jew modifikazzjoni ta’
l-anatomija jew ta’ xi pro`ess fi\jolo[iku; u
(d) kontroll tal-kon`epiment u li ma jiksibx l-azzjoni inti\a prin`ipali tieg]u fi jew fuq il-[isem tal-bniedem b’mezzi farmakolo[i`i, immunolo[i`i jew metaboli`i, imma li jista’ jkun assistit fil-funzjoni tieg]u b’dawk il-mezzi;
''apparat ta’ radjonuklidi'' tfisser preparazzjoni li g]andha ter[a’ ti[i mwaqqfa jew kombinata ma’ radjonuklidi fir-radjofarma`ewtiku finali, soltu qabel l-amministrazzjoni tieg]u;
''Awtorità dwar il-Medi`ini'' tfisser l- Awtorità mwaqqfa ta]t l- artikolu 4;

Kap. 31.

''Bord ta’ Revi\joni dwar il-Medi`ini'' tfisser il-Bord imwaqqaf ta]t l-artikolu 14;
''dentist'' tfisser persuna li tkun awtorizzata te\er`ita dik il- professjoni ta]t l-Ordinanza dwar il-Professjoni Medika u l- Professjonijiet li g]andhom x’jaqsmu mag]ha jew xi li[i o]ra li tissostiwixxi dik l-Ordinanza;
''detentur ta’ li`enza'' tfisser persuna li tkun id-detentur ta’
li`enza g]al xi attività partikolari u mog]tija ta]t dan l-Att;
''dispensa" tinkludi bejg] jew forniment ta’ prodotti medi`inali;
''distribuzzjoni bl-ingrossa" dwar prodott medi`inali, tinkludi dawk l-attivitajiet kollha li jikkonsistu fl-akkwist, it-ti\mim, il- forniment, id-distribuzzjoni, esportazzjoni jew importazzjoni ta’ prodotti medi`inali ]lief g]all-bejg] bl-imnut jew g]al u\u personali;
''esperiment kliniku'' tfisser investigazzjoni li ssir fuq bnedmin u li tkun inti\a li tiskopri jew tivverifika l-effetti klini`i, farmakolo[i`i jew farmakodinami`i o]ra ta’ xi prodott medi`inali wie]ed jew aktar li jkun qed ji[i investigat, jew biex ji[u identifikati reazzjonijiet
A 143
kuntrarji ta’ xi prodott medi`inali wie]ed jew aktar li jkun qed ji[i investigat jew biex isir studju ta’ l-assorbiment, d-distribuzzjoni, l- metaboli\mu u t-tne]]ija minn [ol-[isem ta’ xi prodott medi`inali wie]ed jew aktar li jkun qed ji[i investigat bil-g]an li ji[i a``ertat kemm dak il-prodott ikun wie]ed sigur jew effika`i; u tinkludi esperiment klini`i li jsiru f’xi post wie]ed jew f’diversi postijiet, sew lokalment sew f’xi stat wie]ed jew aktar rikonoxxuti mill- Awtorità dwar il-Li`enzjar;
''farmakopeia rikonoxxuta'' tfisser farmakopeia rikonoxxuta b’regoli g]all-fini ta’ dan l-Att;
''formola ma[istrali'' tfisser prodott medi`inali ppreparat fi spi\erija skond ri`etta li ssir g]al pazjent individwali;
''formola uffi`jali'' tfisser prodott medi`inali li jkun im]ejji fi spi\erija skond istruzzjonijiet li jkun hemm f’ri`etta ta’ farmakopoeia rikonoxxuta u li jkun inti\ li ji[i fornut direttament lil pazjent li jmur biex jinqeda minn dik l-ispi\erija;
''ingredient'' dwar il-manifattura jew il-preparazzjoni ta’ xi sustanza, tinkludi kull ma jkun l-uniku ingredjent attiv tas-sustanza kif din tkun manifatturata jew preparata;
''ippakkettjar fuq barra'' tfisser l-ippakkettjar li fih jitqieg]ed l- ippakkettjar immedjat;
''ippakkettjar immedjat'' tfisser il-kontenitur jew forma o]ra ta’
ippakkettjar immedjat li jkun f’kuntatt mal-prodott medi`inali;
''ippakkettjar minn qabel'' tfisser l-g]emil li bih spi\jar jaqsam prodott medi`inali fi kwantitajiet aktar adatti g]all-u\u ta’ pazjent individwali, billi hekk jibdel l-ippakkettjar fuq barra ta’ dan il-prodott biex ikun jista’ jeffettwa l-bejg];
''ittikkettjar'' tfisser informazzjoni li tkun qeg]da fuq l- ippakkettjar immedjat jew fuq barra;
''kirurgu veterinarju'' tfisser persuna li tkun awtorizzata te\er`ita dik il- professjoni ta]t l-Att dwar is-Servizz Veterinarju, jew xi li[i o]ra li tissostiwixxi dak l-Att;
''kompo\izzjoni'' dwar prodott medi`inali, tfisser l-ingredjenti li jikkostitwuh u l-proporzjonijiet, u l-gradi ta’ qawwa, l-kwalità u l- purezza, li bihom dawk l-ingredjenti jkunu rispettivament jinsabu fih u skond ma jista’ ji[i stabbilit fil-farmakopoeia rikonoxxuta;
''kontenitur'' dwar prodott medi`inali, tfisser l-ippakkettjar
A 144
immedjat jew l-ippakkettjar fuq barra;
''kummer`'' tfisser attività ekonomika [estita sew minn individwu sew minn korp ta’ persuni, kemm b’mod korporat kemm mhux korporat, u tinkludi l-e\er`izzju ta’ xi professjoni;
''laboratorju rikonoxxut'' tfisser laboratorju rikonoxxut b]ala tali mill-Awtorità dwar il-Li`enzjar g]all-finijiet ta’ dan l-Att;
''leaflets [o pakkett'' tfisser leaflet li jkun fiha informazzjoni g]all-utent u li tkun tinsab flimkien mal-prodott medi`inali;
l-Att;
''li`enza'' tfisser li`enza ma]ru[a ta]t id-disposizzjonijiet ta’ dan
''manifattura'', dwar prodott medi`inali, tinkludi pro`ess li jsir fil-kors tal-manifattura ta’ prodott, imma ma tinkludix it-tidwib jew it-tifrix ta’ prodott fi, jew id-dilwizzjoni jew it-ta]lit tieg]u ma’ xi sustanza o]ra u\ata b]ala vettura g]all-fini li din ti[i amministrata;
''marda'' tinkludi kull feriment, u[ig] jew kondizzjoni ]a\ina, sew jekk tal-[isem jew tal-mo]];
''Ministru'' tfisser il-Ministru responsabbli g]as-sa]]a pubblika; "o[[etti ta’ l-ikel" g]andha l-istess tifsira b]alma g]andha ta]t
l-Att dwar is-Sigurtà fl-Ikel;
''pakkett'', dwar prodott medi`inali, tfisser kaxxa, pakkett jew o[[ett ie]or li jing]alqu fih, jew ikunu inti\i li jing]alqu fih, xi kontenitur tal-prodott wie]ed jew aktar u, meta tali kaxxa, pakkett jew o[[ett ie]or ikun, jew ikollu hu nnifsu jing]alaq f’xi kaxxa, pakkett jew o[[ett ie]or wie]ed jew aktar, tinkludi kull tali kaxxa, pakkett jew o[[ett ie]or;
''persuna kwalifikata" tfisser li tkun persuna kwalifikata g]ar- rigward ta’ li`enza ta’ manifattur kif provdut fl-artikolu 31(1)(e);
''persuna responsabbli'' tfisser persuna li tkun responsabbli fir- rigward ta’ li`enza ta’ negozjant bl-ingrossa kif provdut fl-artikolu
55(1)(d);
''pharmacy technician'' tfisser persuna awtorizzata biex ta[ixxi b]ala tali ta]t l-Ordinanza dwar il-Professjoni Medika u l- Professjonijiet li g]andhom x’jaqsmu mag]ha, jew xi li[i o]ra li tissostitwixxi dik l-Ordinanza;
"preparati erbali" tfisser preparati rizultat ta’ sustanzi erbali li
A 145
[ew so[[etti g]al pro`essi ta’ trattament b]ala estrazzjoni, distillazzjoni, espressjoni, frazzazzjoni, purifikazzjoni, kon`entrazzjoni u fermentazzjoni. Dawn jinkludu sustanzi erbali li [ew trasformati fi trab, mkissra f’bi``iet, \jut essenzjali, tinturi, estratti, meraq mag]sur u `ertu materjal likwidu u li jnixxi li [ie pro`essat;
''prattika tajba'' dwar il-prattika tal-manifattura, il-prattika tal- laboratorju, il-prattika tad-distribuzzjoni u l-prattika tal-bejg] minn spi\erija tfisser standards g]all-e\ekuzzjoni kif imiss ta’ l- attività relattiva stabbilita minn jew ta]t dan l-Att;
''prekursur ta’ radjonuklidi'' tfisser radjonuklidi li ma jkunx radjofarma`ewtiku, radjonuklidi [eneratur jew apparat ta’ radjonuklidi li jkun prodott g]al radjo-ittikkettjar ta’ xi sustanza o]ra qabel l-amministrazzjoni;
''preskritt'' tfisser preskritt b’regolamenti mag]mulin mill- Ministru ta]t dan l-Att;
''prodott kosmetiku" g]andha l-istess tifsira b]alma g]andha ta]t l-Att dwar is-Sigurezza tal-Prodotti;
''prodott medi`inali'' tfisser kull sustanza jew kombinazzjoni ta’ sustanzi ppre\entati g]all-kura jew il-prevenzjoni ta’ marda fil- bniedem, kif ukoll kull sustanza jew kombinazzjoni ta’ sustanzi li jistg]u ji[u amministrati lill-bniedem sabiex issir dijanjosi medika jew ji[u restawrati, korretti jew modifikati funzjonijiet fi\jolo[i`i fil- bniedem;
"prodott medi`inali erbali" tfisser kull prodott medi`inali li jkollu fih wie]ed jew aktar minn wie]ed ingredjenti erbali b]ala ingredjent attiv, jew wie]ed jew i\jed minn wie]ed preparati erbali, jew wie]ed jew i\jed minn wie]ed sustanzi erbali flimkien ma' wie]ed jew i\jed minn wie]ed preparati erbali;
''prodott medi`inali immunolo[iku'' tfisser xi prodott medi`inali li jikkonsisti f’va``in, tossin, serum jew prodott ta’ aller[en hekk li:
(a) va``in, tossin u serum g]andhom jinkludu:
attiva;
(i) a[enti u\ati biex jipprodu`u immunità
(ii) a[enti u\ati g]ad-djanjosi ta’ l-immunità;
(iii) a[enti u\ati biex jipprodu`u immunità
passiva; u
A 146
(b) ''prodott ta’ aller[en'' tfisser prodott medi`inali li jkun inti\ biex jidentifika jew i[ib alterazzjoni miksuba spe`ifika fir-rispons immunolo[iku g]al a[ent aller[izzanti;
''prodott medi`inali investigattiv'' tfisser forma farma`ewtika ta’ sustanza attiva jew pla`ebo li ji[i ttestjat jew u\at b]ala riferenza f’xi esperiment kliniku, u tinkludi prodotti li di[à jkollhom awtorizzazzjoni ta’ tqeg]id fis-suq imma li l-u\u jew l-assembla[[ tag]hom (formulat jew ippakkettjat) b’mod differenti mill-forma awtorizzata, jew meta jintu\aw g]al xi indikazzjoni mhux awtorizzata, jew meta jintu\aw g]all-ksib ta’ informazzjoni ulterjuri dwar il-forma awtorizzata;
''prodott medi`inali omeopatiku'' tfisser xi prodott medi`inali preparat minn prodotti, sustanzi jew kompo\izzjonijiet imsejj]a
]a\niet omeopati`i skond pro`edura ta’ manifattura omeopatika
deskritta f’xi farmakopoeia rikonoxxuta;
''radjofarma`ewtiku'' tfisser prodott medi`inali li, meta jkun lest g]all-u\u, jkun fih xi radjonuklidi wie]ed jew aktar inklu\i g]al skop medi`inali;
''radjonuklidi [eneratur'' tfisser sistema li tkun tinkorpora fiha radjonuklidi [enitur fiss li minnu tkun prodotta radjonuklidi filjali li g]andha titne]]a b’eluzzjoni jew b’xi metodu ie]or u tintu\a f’radjofarma`ewtiku;
''regoli'' tfisser regoli mag]mula mill-Awtorità dwar il-Li`enzjar ta]t id-disposizzjonijiet ta’ dan l-Att;
''reklamar'' dwar prodotti medi`inali tinkludi xi forma ta’ informazzjoni li ting]ata minn dar g]all-o]ra, attività ta’ kkanvassjar jew t]ajjir inti\i biex i[ibu ’l quddiem il-]ru[ ta’ ri`etti, il-forniment, il-bejg] jew il-konsum ta’ prodotti medi`inali u ming]ajr pre[udizzju g]all-[eneralità ta’ dak imsemmi hawn qabel tinkludi b’mod partikolari:
(a) ir-reklamar ta’ prodotti medi`inali lill-pubbliku
[enerali;
(b) ir-reklamar ta’ prodotti medi`inali lil persuni kwalifikati li jippreskrivuhom jew jipprovduhom;
(`) vi\ti minn rappre\entanti medi`i jew bejjieg]a lil persuni kwalifikati li jippreskrivu prodotti medi`inali;
(d) l-g]oti ta’ kampjuni;
A 147
(e) it-t]ajjir li ji[u preskritti jew provduti prodotti medi`inali, b’rigal, offerta jew weg]da ta’ xi benefi``ju jew bonus, sew fi flus sew g]al xi korrispettiv, ]lief meta l-valur intrinsiku ta’ dak it-t]ajjir ikun wie]ed minimu;
(f) l-isponsorjar ta’ laqg]at promozzjonali li g]alihom jattendu persuni kwalifikati li jippreskrivu jew jipprovdu prodotti medi`inali;
(g) l-isponsorjar ta’ xi kungress xjentifiku li g]alih jattendu persuni kwalifikati li jippreskrivu jew jipprovdu prodotti medi`inali u b’mod partikolari meta ji[i offrut il-]las ta’ l-ispejje\ tag]hom ta’ l-ivvja[[ar u g]all-akkomodazzjoni f’konnessjoni ma’ dan;
i\da g]andha teskludi:
(i) l-ittikkettjar u leaflets li jitqassmu mal- pakkett, kif jista' ji[i stabbilit skond id-disposizzjonijiet tat-Taqsima III, Titolu I ta’ dan l-Att;
(ii) korrispondenza, ukoll jekk din ikollha mag]ha materjal ta’ xorta mhux promozzjonali, li ting]ata b’risposta g]al xi mistoqsija spe`ifika dwar xi prodott medi`inali partikolari;
(iii) materjal fattwali u informattiv fil-forma ta’ t]abbira jew materjal ta’ riferenza li jirrigwarda tibdil fl- ippakkettjar, twissijiet ta’ reazzjonijiet kuntrarji b]ala parti minn prekawzjonijiet [enerali dwar medi`inali, katalogi kummer`jali, listi ta’ prezzijiet u materjal ie]or ta’ xorta simili sakemm dak il-materjal ma jkunx jinkludi xi pretensjoni dwar prodott;
(iv) kull dikjarazzjoni li tirrigwarda s-sa]]a jew xi marda tal-bniedem, sakemm ma jkun hemm ebda riferenza, sew diretta sew mhux diretta, g]al xi prodott medi`inali.
''ri`etta medi`inali'' tfisser ri`etta ma]ru[a minn persuna professjonali kwalifikata biex tippreskrivi prodotti medi`inali b’dan l-Att jew ta]tu;
''skop medi`inali'' tinkludi xi wie]ed jew aktar mill-g]anijiet li
[ejjin:
(a) il-kura jew il-prevenzjoni ta’ marda;
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(b) id-dijanjosi ta’ marda jew l-a``ertament ta’ l- e\istenza, il-grad jew l-estent ta’ xi kondizzjoni fi\jolo[ika;
(`) il-kontra`ezzjoni; (d) l-anestesija;
(e) il-prevenzjoni jew l-ind]il fl-operazzjoni normali ta’ funzjoni fi\jolo[ika, sew jekk permanentement jew temporanjament, u sew jekk bit-terminazzjoni, riduzzjoni jew postponiment jew bi\-\jieda jew l-a``elerazzjoni tat-t]addim ta’ dik il-funzjoni jew b’xi mod ie]or;
''spi\jar'' tfisser persuna li tkun awtorizzata te\er`ita dik il- professjoni ta]t l-Ordinanza dwar il-Professjoni Medika u l- Professjonijiet li g]andhom x’jaqsmu mag]ha, jew xi li[i o]ra li tissostitwixxi dik l-Ordinanza;
''Suprintendent tas-Sa]]a Pubblika'' g]andha l-istess tifsira b]alma hu mog]ti lilha bl-artikolu 4 ta’ l-Ordinanza dwar l- Organizzazzjoni tad-Dipartiment tas-Sa]]a;
''sustanza'' tfisser xi ]a[a irrispettivament mill-ori[ini li jista’ jkun mill-bniedem (inklu\ demm tal-bniedem u prodotti [ejjin mid- demm tal-bniedem), mill-annimali (inklu\i mikro-organi\mi, annimali s]a], partijiet ta’ organi, tnixxija minn annimali, estratti), mill-]axix (inklu\i mikro-organi\mi, pjanti, partijiet minn pjanti, tnixxija minn ]xejjex, estratti), jew mill-kimika (inklu\i elementi, materjal kimiku li jinsab b’mod naturali jew prodotti kimi`i miksuba b’tibdil kimiku jew sintesi kimika);
"sustanzi erbali" tfisser kull pjanta forma ta’ bi``iet, imqatta’ jew kwa\i s]i]a, partijiet ta’ pjanti, algi, fungi, lichens mhux pro`essati, [eneralment niexfa imma kultant friski; `ertu materjal jew likwidu li jnixxi mill-pjanti li jkun g]adu ma [iex so[[ett g]al xi pro`ess ta’ trattament partikolari wkoll;
''tabib'' tfisser persuna li tkun awtorizzata te\er`ita dik il- professjoni ta]t l-Ordinanza dwar il-Professjoni Medika u l- Professjonijiet li g]andhom x’jaqsmu mag]ha jew xi li[i o]ra li tissostitwixxi dik l-Ordinanza;
''tag]mel assembla[['', dwar prodott medi`inali, tfisser li tag]laq il-prodott f’kontenitur li jing]ata tikketta qabel ma jinbieg] jew ji[i fornut il-prodott, jew, meta l-prodott ikun di[à mag]luq fil- kontenitur li g]andu jinbieg] jew ji[i fornut fih, l-ittikkettjar tal- kontenitur qabel ma jinbieg] jew ji[i fornut il-prodott fih, u g]andha
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wkoll tinkludi l-g]emil ta’ introduzzjoni ta’ informazzjoni approvata fil-kontenitur jew fuqu, u ''assembla[['' g]andha tiftiehem skond hekk;
''uffi`jal awtorizzat'' dwar l-Awtorità dwar il-Medi`ini tfisser xi uffi`jal jew impjegat ta’ l-Awtorità jew persuna o]ra awtorizzata mill-Awtorità biex ta[ixxi f’isimha u g]ar-rigward ta’ l-Awtorità dwar il-Li`enzjar tfisser uffi`jal jew impjegat tad-Dipartiment kif imsemmi fl-artikolu 5 ta’ l-Ordinanza dwar l-Organizzazzjoni tad- Dipartiment tas-Sa]]a, li jkun awtorizzat mill-Awtorità dwar il- Li`enzjar biex ja[ixxi f’isimha.

TAQSIMA II

AMMINISTRAZZJONI

Titolu I - Awtorità dwar il-Li`enzjar

3. (1) Is-Suprintendent g]as-Sa]]a Pubblika jkun l- Awtorità dwar il-Li`enzjar g]all-g]anijiet ta' dan l-Att.

(2) L-Awtorità dwar il-Li`enzjar ikollha dawn il-funzjonijiet li
[ejjin:
(a) li tistabbilixxi standards biex ti\gura l-kwalità, s- sigurezza u l-effika`ja ta’ prodotti medi`inali;
(b) li tistabbilixxi standards g]all-operazzjoni ta’
spi\eriji;

Kap. 94.

Funzjonijiet ta’

l-Awtorità dwar

il-Li`enzjar.

ippakkjar mill-[did u ttikkettjar ta’ prodotti medi`inali jew ta’
xi sustanza li tintu\a jew hi inti\a li tintu\a f’dawk il-prodotti;
(d) li tistabbilixxi standards g]all-operazzjoni ta’
distribuzzjoni bl-ingrossa;
(e) li tistabbilixxi standards g]all-ittestjar jew l-analisi ta’ prodotti medi`inali jew ta’ xi sustanza li tintu\a jew hi inti\a li tintu\a f’dawk il-prodotti;
(f) li tistabbilixxi standards g]at-twettiq ta’ esperimenti klini`i;
(g) li tistabbilixxi standards g]ar-rapportar ta’ reazzjonijiet avversi, reazzjonijiet avversi serji jew reazzjonijiet avversi mhux mistennija suspetti u jipprovdi g]all-[bir jew il-
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pre\entazzjoni ta’ informazzjoni relatata mill-persuna jew l- attività regolati b’dan l-Att jew ta]tu;
(h) li tistabbilixxi standards dwar ir-reklamar ta’
prodotti medi`inali;
(i) li tag]ti pariri lill-Ministru fl-g]emil ta' regolamenti dwar il-klassifikazzjoni ta’ prodotti medi`inali;
(j) li to]ro[, i[[edded, temenda, tibdel, tissospendi jew tjirrevoka awtorizzazzjonijiet ta’ tqeg]id fis-suq g]al prodotti medi`inali;
(k) li tirtira jew ti[bor lura prodotti medi`inali mis-suq fl-interess tas-sa]]a pubblika; u
(l) li ti\gura konformità ma’ l-obbligi internazzjonali li l-Gvern ta’ Malta jkollu dwar xi ]a[a regolata minn jew ta]t dan l-Att;
(m) li to]ro[, i[[edded, temenda, tibdel, tissospendi jew tirrevoka xi awtorizzazzjoni jew li`enza li tista’ tkun me]tie[a b’dan l-Att jew ta]tu;
(n) li tag]mel ispezzjonijiet fuq kull attività, servizz jew pro`eduri dwar prodotti medi`inali u li tag]mel dak kollu li jista’ jkun me]tie[ g]all-fini li ti[i \gurata konformità ma’ kull disposizzjoni ta' dan l-Att jew mag]mula ta]tu;
(o) li tawtorizza r-reklamar u l-promozzjoni ta’ prodotti medi`inali;
(p) li tag]mel kull attività o]ra li tista’ ti[i ordnata;
(q) li tag]ti parir lill-Ministru dwar xi ]a[a konnessa mal-funzjonijiet tag]ha jew ma’ xi disposizzjoni o]ra ta’ dan l- Att.
(3) L-Awtorità dwar il-Li`enzjar tista’ b’ordni tiddelega xi funzjoni minn dawk imsemmija fis-subartikolu (2)(m), (n) u (o) lill- Awtorità dwar il-Medi`ini.
(4) L-Awtorità dwar il-Li`enzjar g]andha ti[bor dawk id- drittijiet li jistg]u jkunu preskritti g]all-fini ta’ dan l-Att:
I\da dawn ir-regolamenti jistg]u jipprovdu g]at-twarrib mill-]las ta' dawk id-drittijiet f'dawk i`-`irkostanzi li jistg]u ji[u preskritti.
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(5) Sabiex isir l-e\er`izzju kif imiss tal-funzjonijiet tag]ha, l-Awtorità dwar il-Li`enzjar tista’ tistabbilixxi kumitati konsultattivi kif tista’ tqis li jkun me]tie[.

Titolu II - L-Awtorità dwar il-Medi`ini

4. G]andu jkun hemm Awtorità dwar il-Medi`ini, li titmexxa minn Uffi`jal E\ekuttiv Ewlieni.

5. (1) L-Awtorità dwar il-Medi`ini g]andha tkun korp mag]qud li jkollu personalità [uridika separata u distinta u li tkun tista’, so[[etta biss g]ad-disposizzjonijiet ta’ dan l-Att, tag]mel kuntratti, tikseb, ikollha f’idejha u tiddisponi minn kull xorta ta’ proprjetà kemm mobbli kemm immobbli, li timpjega persunal g]all- finijiet ta’ l-operazzjonijiet tag]ha, u li t]arrek u ti[i m]arrka, u li lilha [iet assenjat jew tista’ ti[i assenjata kull funzjoni jew operazzjoni tal-gvern ta]t din il-li[i jew kull li[i o]ra.

(2) Ir-rappre\entanza legali u [uridika ta’ l-Awtorità dwar il- Medi`ini tkun vestita fl-Uffi`jal E\ekuttiv Ewlieni:
I\da l-Awtorità dwar il-Medi`ini tista’ ta]tar lil xi wie]ed jew aktar mill-uffi`jali jew impjegati tag]ha biex jidher minflokha u f’isimha fi pro`edimenti [udizzjarji jew fuq xi att, kuntratt, istrument jew dokument ie]or li jkun.

6. (1) L-Awtorità dwar il-Medi`ini jkollha dawn il- funzjonijiet li [ejjin:

(a) li taqdi dawk dawk il-funzjonijiet li jistg]u ji[u lilha delegati mill-Awtorità dwar il-Li`enzjar skond l-artikolu 3(3);
(b) li tassisti u tag]ti pariri lill-Awtorità dwar il- Li`enzjar fuq kull ma jirrigwarda r-regolament ta’ prodotti medi`inali u attivitajiet relatati;
(`) li tid]ol g]al dawk l- attivitajiet u pro[etti li jistg]u jkunu me]tie[a jew spedjenti g]all-e\er`izzju kif imiss tal- funzjonijiet tag]ha;
(d) li tistabbilixxi dawk il-pro`eduri li jistg]u jkunu me]tie[a biex tikseb u tivvaluta informazzjoni dwar is- sigurezza, il-kwalità u l-effika`ja ta’ prodotti medi`inali biex dawn jitqeg]du fis-suq f’Malta;
(e) li tistabbilixxi dawk il-pro`eduri li jistg]u jkunu me]tie[a biex tag]mel dawk il-valutazzjonijiet dwar is- sigurezza, l-kwalità u l-effika`ja ta’ prodott medi`inali kif tista’

Twaqqif ta’ l- Awtorità dwar il-Medi`ini.

Personalità [uridika ta’ l- Awtorità dwar il-Medi`ini.

Funzjonijiet ta’

l-Awtorità dwar

il-Medi`ini.

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tqis li jkun me]tie[ biex dawk il-prodotti jitqeg]du fis-suq f’Malta;
(f) li tistabbilixxi dawk il-pro`eduri li jistg]u jkunu me]tie[a g]as-sorveljar u l-ksib ta’ rapporti fuq il-kwalità, is- sigurtà jew l-effika`ja ta’ prodotti medi`inali;
(g) li tag]mel rakkomandazzjonijiet lill-Awtorità dwar il-Li`enzjar fuq standards u li`enzjar;
(h) li tag]ti parir lill-Awtorità dwar il-Li`enzjar fuq il- prekawzjonijiet jew restrizzjonijiet li prodotti medi`inali jistg]u jkunu so[[etti g]alihom g]at-tqeg]id tag]hom fis-suq jew g]all-u\u kontinwat tag]hom f’Malta; u
(i) li tag]ti, kull meta jkun hekk jidhrilha adatt jew hekk tintalab tag]mel mill-Awtorità dwar il-Li`enzjar, pariri jew tag]mel rakkomandazzjonijiet lill-Awtorità dwar il- Li`enzjar dwar xi ]a[a li jkollha x’taqsam mal-funzjonijiet tag]ha.
(2) Sabiex twettaq il-funzjonijiet tag]ha sew, l-Awtorità dwar il-Medi`ini tista’ titlob il-produzzjoni ta' dik l-informazzjoni jew dokumenti li jen]tie[u g]al xi wa]da mill-funzjonijiet tag]ha, u tista' tikseb il-parir ta’ espert minn kull persuna, li ma tkunx membru tal- Bord ta’ Revi\joni dwar il-Medi`ini, li jkollha l-kwalifiki u l- esperjenza me]tie[a fl-oqsma elenkati fl-Ewwel Skeda, u tista’ wkoll tistabbilixxi dawk il-kumitati konsultattivi kif tista’ tqis li jkun me]tie[; u dan g]al g]anijiet kemm [enerali kemm spe`ifi`i.
(3) L-Awtorità dwar il-Medi`ini g]andha ti[bor dawk id- drittijiet li jistg]u jkunu preskritti g]all-fini ta’ dan l-Att:

Organizzazzjoni ta’ l-Awtorità dwar il- Medi`ini.

L-Uffi`jal E\ekuttiv Ewlieni ta’ l- Awtorità dwar il-Medi`ini.

I\da dawn ir-regolamenti jistg]u jipprovdu g]at-twarrib mill-]las ta' dawk id-drittijiet f'dawk i`-`irkostanzi e``ezzjonali li jistg]u ji[u preskritti.

7. L-Awtorità g]andha twaqqaf dawk id-Direttorati li jkunu me]tie[a, u g]andha tassenja lil kull Direttorat dawk il-funzjonijiet li jidhrilha spedjenti g]all-e\er`izzju tajjeb tal-funzjonijiet tag]ha.

8. (1) L-Uffi`jal E\ekuttiv Ewlieni g]andu jin]atar mill- Ministru minn fost persuni li jkunu kwalifikati kif imiss u li jkollhom esperjenza f’settur mediku, farma`ewtiku jew xjenza medika.

(2) L-Uffi`jal E\ekuttiv Ewlieni jkun responsabbli g]all- amministrazzjoni [enerali u l-prestazzjoni ta' l-Awtorità, inklu\a l- amministrazzjoni tal-]idmiet ta’ kull jum li jsiru mill-Awtorità.
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(3) Persuna ma g]andhiex tkun eli[ibbli li tin]atar jew li jkollha il-kariga ta’ Direttur jew Uffi`jal E\ekuttiv Ewlieni ta’ l- Awtorità jekk:
(i) tkun membru tal-Kamra tad-Deputati; jew
(ii) tkun Im]allef jew Ma[istrat; jew
(iii) tkun, skond il-li[i, inabilita; jew
(iv) tkun [iet dikjarata falluta jew tkun g]amlet kompo\izzjoni jew arran[ament mal-kredituri tag]ha; jew
(v) [iet misjuba ]atja ta' frodi jew ta' xi reat reat ie]or kontra l-fidu`ja pubblika, jew tkun mod ie]or [iet kundannata g]al ]abs g]al \mien ta' mhux anqqas minn tliet xhur; jew
(vi) ikollha xi interessi finanzjarji jew o]ra, diretti jew indiretti f’xi intrapri\a jew attività li x’aktarx jolqtu t-twettiq tal-funzjonijiet tag]ha b]ala membru ta’ l- Awtorità.
(4) (a) L-Uffi`jal E\ekuttiv Ewlieni ta’ l-Awtorità g]andu jibqa’ f’dik il-kariga g]al perjodu mhux i\jed minn ]ames snin imma huwa jkun eli[ibbli li jer[a’ jin]atar g]al perjodi o]ra li kull wie]ed minnhom ma jistax je``edi ]ames snin.
(b) L-Uffi`jal E\ekuttiv Ewlieni ta’ l-Awtorità jista’ jitne]]a mill-kariga mill-Ministru qabel l-iskadenza ta\-\mien ta’ l- kariga tieg]u meta, fil-fehma tal-Ministru, jkun ]ati ta’ tmexxija mhux kif imiss jew min]abba fl-inkapa`ità tieg]u li jkompli jwettaq il-funzjonijiet tal-kariga tieg]u, sew jekk min]abba f’inkapa`ità tal- mo]] jew tal-[isem, jew g]al xi ra[uni o]ra, jew min]abba fi m[ieba mhux kif imiss.

9. (1) Bla ]sara g]ad-disposizzjonijiet tal-Kostituzzjoni u ta’ xi li[i o]ra li tapplika dwar dan, u ming]ajr pre[udizzju g]ad- disposizzjonijiet l-o]ra ta’ dan l-Att, il-]atra ta’ uffi`jali jew impjegati ta’ l-Awtorità g]andha ssir mill-Awtorità. Il-pattijiet u l- kondizzjonijiet ta’ impjieg g]andhom ji[u stabbiliti mill-Awtorità bi ftehim mal-Ministru, mog]ti wara konsultazzjoni mal-Ministru tal- finanzi.

(2) Il-Prim Ministru jista’, fuq talba ta’ l-Awtorità, wara li din tikkonsulta mal-Ministru, minn \mien g]al \mien u b’ordni jinga[[a uffi`jal pubbliku jag]mel xog]ol ma’ l-Awtorità f’dik il-kapa`ità u g]al dak i\-\mien u ta]t dawk il-kondizzjonijiet li jistg]u ji[u

Impjegati ta’ l- Awtorità dwar il-Medi`ini.

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stabbiliti dwar dak l-uffi`jal hekk inga[[at.
(3) Il-Prim Ministru jista’ f’kull waqt jirrevoka ordni b]al dak mog]ti ta]t is-subartikolu (2).
(4) Meta uffi`jal ji[i inga[[at biex jaqdi dmirijietu ma’ l- Awtorità dak l-uffi`jal g]andu, matul i\-\mien li dak l-ordni jibqa’ jse]], ikun ta]t id-direzzjoni amministrativa u l-kontroll ta’ l-Uffi`jal E\ekuttiv Ewlieni u g]andu xort’o]ra jibqa’ u j\omm kull dritt u dmir li jkollu b]ala uffi`jal pubbliku u g]all-finijiet ta’ xi li[i li tirrigwarda l-pensjoni g]as-servizz mal-gvern, is-servizz li jing]ata ma’ l- Awtorità g]andu jitqies b]ala servizz mal-Gvern:
I\da ma g]andu jittie]ed ebda qies, fl-evalwazzjoni ta’ emolumenti pensjonabbli ta’ dak l-uffi`jal g]all-finijiet ta’ xi li[i li tirrigwarda l-pensjonijiet g]as-servizz mal-gvern, ta’ kull allowance, bonus jew gratwità m]allsa lil dak l-uffi`jal mill-Awtorità b’\jieda ma’ dak li jkollu jedd g]alih b]ala uffi`jal pubbliku:

Kontijiet ta’ l- Awtorità dwar il-Medi`ini.

I\da wkoll waqt dak i\-\mien li dwaru huwa jkun hekk inga[[at biex iwettaq dmirijiet ma’ l-Awtorità il-pattijiet u l- kondizzjonijiet tas-servizz tieg]u ma g]andhomx ikunu inqas favorevoli minn dawk marbuta mal-]atra tieg]u ta]t il-Gvern matul il-perjodu hawn qabel imsemmi. Dawk il-pattijiet u l-kondizzjonijiet ma g]andhomx jitqiesu b]ala inqas favorevoli unikament min]abba f’li ma jkunux g]alkollox identi`i ma’ jew superjuri g]al dawk li l- uffi`jal involut ikun igawdi fid-data meta ssir dik l-offerta, jekk dawk il-pattijiet u l-kondizzjonijiet, me]udin ilkoll flimkien, fil-fehma tal- Prim Ministru jkunu sostanzjalment joffru benefi``ji ekwivalenti jew akbar.

10. (1) L-Awtorità g]andha \\omm kotba tal-kontijiet kif imiss b’dak il-mod li l-Ministru responsabbli g]all-finanzi jista’ minn

\mien g]al \mien jordna. Dawk il-kontijiet g]andhom ikunu verifikati minn awditur li jin]atar g]al dan il-fini mill-Awtorità u g]andhom iktar minn hekk ikunu so[[etti g]all-verifika ta’ l-Awditur
{enerali.
(2) L-Awtorità g]andha, mhux aktar tard minn sitt [img]at wara tmiem kull sena finanzjarja, tippre\enta lill-Ministru u lis- segretarju permanenti l-kontijiet verifikati flimkien ma’ rapport fuq il-]idma ta’ l-a[enzija liema rapport g]andu jiddikjara l-mod li bih tkun operat l-a[enzija biex twettaq il-funzjonijiet tag]ha u l-pjanijiet li jkollha g]all-futur.
(3) Ir-rapporti msemmija fis-subartikolu (2) g]andhom jitqeg]du fuq il-Mejda tal-Kamra tad-Deputati mill-Ministru mhux
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i\jed tard minn sitt [img]at wara li dawn jaslu, jew meta matul dak il- perjodu ma jkunx hemm sessjoni tal-Kamra mhux i\jed tard mit-tieni [img]a wara li l-Kamra tkompli bis-seduti tag]ha.

11. }lief bl-approvazzjoni tal-Ministru, l-Awtorità ma g]andha tag]mel ebda kuntratt g]all-forniment ta’ merkanzija jew materjal jew g]all-esekuzzjoni ta’ xog]lijiet jew g]all-g]oti ta’ servizzi, lil jew g]all-benefi``ju ta’ l-Awtorità, li jkun stmat mill- Awtorità li jinvolvi spi\a li tkun te``edi il-mitt elf lira jew kull ammont ie]or li l-Ministru jista’ minn \mien g]al \mien jordna bil- miktub, ]lief wara li jkun [ie ppubblikat avvi\ tal-]sieb li l-Awtorità jkollha li tag]mel dak il-kuntratt u jkunu n]ar[u sej]iet g]al offerti kompetittivi.

12. L-Uffi`jal E\ekuttiv Ewlieni u kull uffi`jal e\ekuttiv u impjegat ie]or ta’ l-Awtorità g]andhom jikkonformaw ru]hom ma’ u j]arsu kull valur tas-servizz pubbliku u tal-Kodi`i ta’ Etika li jista’ jkun fis-se]] minn \mien g]al \mien dwar l-uffi`jali pubbli`i.

13. L-Awtorità g]andha tkun e\enti minn kull responsabbiltà g]all-]las ta’ taxxa fuq l-income jew taxxa fuq id-dokumenti li f’dak il-waqt ikunu fis-se]] f’Malta.

Titolu III - Bord ta’ Revi\joni dwar il-Medi`ini

14. (1) Ikun hemm Bord ta’ Revi\joni dwar il-Medi`ini li jkun mag]mul minn tliet membri u minn tliet membri sostituti li jin]atru mill-Ministru, kif [ej:

(a) persuna li tkun persuna li tipprattika l-professjoni legali u li jkollha mill-anqas seba’ snin esperjenza legali u li tkun chairperson; u
(b) mill-anqas \ewg persuni li jkollhom il-kwalifiki u l- esperjenza teknika u xjentifika fil-qasam regolatorju tal- medi`ini.
(2) Il-Ministru g]andu ja]tar uffi`jal pubbliku biex jag]milha ta’ segretarju tal-Bord ta’ Revi\joni dwar il-Medi`ini.
(3) Il-membri tal-Bord ta’ Revi\joni dwar il-Medi`ini g]andhom ji[u ma]tura mill-Ministru g]al \mien tliet snin, u ta]t dawk il-pattijiet u l-kondizzjonijiet li jistg]u ji[u spe`ifikati fil-]atra tag]hom. Membri li ji[u hekk ma]tura jistg]u jer[g]u jin]atru mill- [did meta jiskadi \-\mien tag]hom fil-kariga.
(4) Meta xi membru tal-Bord ta’ Revi\joni dwar il-Medi`ini ma jkunx jista’ ja[ixxi, l-membru sostitut li jkollu l-istess kwalifiki

Akkwisti mill- Awtorità dwar il-Medi`ini.

Kif japplika l- Kodi`i ta’ Etika.

E\enzjoni mit- taxxa, e``.

Twaqqif ta’ Bord ta’ Revi\joni dwar il-Medi`ini.

A 156
g]andu ja[ixxi minfloku.
(5) Persuna ma tkunx kwalifikata li tibqa’ fil-kariga b]ala membru tal-Bord ta’ Revi\joni dwar il-Medi`ini jekk:
(i) tkun membru tal-Kamra tad-Deputati; jew
(ii) tkun Im]allef jew Ma[istrat; jew
(iii) tkun, skond il-li[i, inabilita; jew
(iv) tkun [iet dikjarata falluta jew tkun g]amlet kompo\izzjoni jew arran[ament mal-kredituri tag]ha; jew
(v) [iet misjuba ]atja ta' frodi jew ta' xi reat reat ie]or kontra l-fidu`ja pubblika, jew tkun mod ie]or [iet kundannata g]al ]abs g]al \mien ta' mhux anqqas minn tliet xhur; jew

Kap. 12.

Bord ta’ Revi\joni dwar il-Medi`ini jista’ ja]tar konsulenti.

(vi) ikollha xi interessi finanzjarji jew o]ra, diretti jew indiretti, f’xi intrapri\a jew attività li x’aktarx jolqtu t-twettiq tal-funzjonijiet tag]ha b]ala membru tal- Bord.
(6) Id-disposizzjonijiet tas-Subtitolu II tat-Titolu II tat-Tielet Ktieb tal-Kodi`i ta' Organizzazzjoni u Pro`edura ~ivili g]andhom jg]oddu, mutatis mutandis, g]all-membri tal-Bord ta' Revi\joni dwar il-Medi`ini li jistg]u ji[u riku\ati jew jistg]u jastjenu milli joqg]odu fuq dak il-Bord waqt is-smig] ta' xi appell.
(7) Persuna ttemm milli tibqa’ membru tal-Bord ta’ Revi\joni dwar il-Medi`ini meta jiskadi \-\mien tal-kariga tag]ha, jew jekk ikun hemm `irkostanzi illi, li kieku ma tkunx membru tal-Bord ta’ Revi\joni dwar il-Medi`ini, ittemm milli tkun kwalifikata g]al ]atra b]al dik.
(8) Membru tal-Bord ta’ Revi\joni dwar il-Medi`ini jista’ jitne]]a mill-kariga mill-Ministru jekk, fil-fehma tieg]u, dak il- membru ma jibqax i\jed idoneu biex ikompli f’dik il-kariga jew ma jkunx baqa’ aktar kapa`i li jwettaq kif imiss id-dmirijiet tieg]u b]ala membru.

15. (1) Fl-esekuzzjoni tal-funzjonijiet tieg]u, il-Bord ta’ Revi\joni dwar il-Medi`ini jista’ jitlob il-parir ta’ kull persuna b’g]arfien fil-materja li jkun sar appell dwarha.

(2) Il-Bord jista’ wkoll je]tie[ lil xi dipartiment u, jew awtorità tal-gvern jipprovdilu dik l-informazzjoni jew dak il-parir li
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jista’ jqis li jkunu me]tie[a g]all-qadi kif imiss tal-funzjonijiet tieg]u.

16. (1) Tkun il-funzjoni tal-Bord ta’ Revi\joni dwar il- Medi`ini:

(a) li jisma’ kull appell mag]mul minn persuna aggravata minn xi rakkomandazzjoni ta’ l-Awtorità dwar il- Medi`ini dwar is-sigurezza, l-kwalità u l-effika`ja ta’ xi prodott medi`inali wara li tkun saret applikazzjoni g]al awtorizzazzjoni ta’ tqeg]id fis-suq li ti[i ppre\entata mill-appellant;
(b) li jag]ti kull parir u jag]mel ir-rakkomandazzjonijiet tieg]u lill-Awtorità dwar il-Li`enzjar dwar appell jew talba li jsirulha.
(2) Flimkien mal-pre\entazzjoni tar-rakkomandazzjonijiet tieg]u lill-Awtorità dwar il-Li`enzjar, il-Bord g]andu wkoll jippre\enta kopja ta’ dawk ir-rakkomandazzjonijiet lill-appellant u lill-Awtorità dwar il-Medi`ini.
(3) Kull appo[[ amministrativ u finanzjarju me]tie[ mill- Bord ta’ Revi\joni dwar il-Medi`ini g]at-twettiq tal-funzjonijiet tieg]u g]andu jing]ata mill-Awtorità dwar il-Li`enzjar.
(4) Bla ]sara g]ad-disposizzjonijiet hawn qabel imsemmija l- affarijiet tal-Bord ta’ Revi\joni dwar il-Medi`ini g]andhom jitmmexxu skond ir-regoli li hemm fit-Tieni Skeda u l-Bord jista’ xort’o]ra jirregola l-pro`edura tieg]u nnifsu.

17. (1) Meta applikant g]al xi awtorizzazzjoni ta’ tqeg]id fis-suq i]oss ru[u aggravat bir-ri\ultanzi u r-rakkomandazzjonijiet mag]mula mill-Awtorità dwar il-Medi`ini li jsiru lill-Awtorità dwar il-Li`enzjar, huwa jista’, fi \mien erbatax-il [urnata minn meta tasallu kopja ta’ dawk ir-ri\ultanzi u rakkomandazzjonijiet, jippre\enta appell quddiem il-Bord ta’ Revi\joni dwar il-Medi`ini.

(2) L-Awtorità dwar il-Li`enzjar tista’, jekk tqis li jkun hekk me]tie[, fi \mien erbatax-il [urnata minn meta jaslu r-ri\ultanzi u r- rakkomandazzjonijiet ta’ l-Awtorità dwar il-Medi`ini fuq is- sigurezza, l-kwalità u l-effika`ja ta’ xi prodott medi`inali, titlob lill- Bord ta’ Revi\joni dwar il-Medi`ini jipprovdilha fehma ulterjuri fuq il-ka\.
(3) Appell jew talba g]al revi\joni g]andhom isiru bil-miktub u g]andu jkollhom mag]hom id-dritt preskritt.
(4) Ir-rikors ta’ l-appell jew talba g]al revi\joni g]andu jkun

Funzjonijiet tal- Bord ta’ Revi\joni dwar il-Medi`ini.

Pro`edura dwar l-appelli.

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fihom b’mod `ar u komprensiv il-fatti li jikkostitwixxu l-appell jew ir-revi\joni u g]andu jkun fihom kull prova u dokumentazzjoni biex isostnu l-pretensjoni li tkun qeg]da ssir u li tista’ tkun me]tie[a sabiex il-Bord jasal biex jidde`iedi dwar il-ka\:
I\da l-Bord ta’ Revi\joni dwar il-Medi`ini jista’ jitlob li ji[u ppre\entati kull tali informazzjoni jew dokumentazzjoni ulterjuri skond ma jista’ jitqies li jkun me]tie[:

Smig] fil- pubbliku.

Kif japplikaw

`erti

disposizzjonijiet

I\da wkoll il-Bord ta’ Revi\joni dwar il-Medi`ini g]andu wara li jikseb l-informazzjoni rilevanti kollha, jippro`essa r-rikors fi
\mien spe`ifikat skond regolamenti li jsiru ta]t dan l-Att.

18. (1) Il-Bord ta’ Revi\joni dwar il-Medi`ini g]andu jappunta s-smig] ta' l-appell fil-pubbliku fi \mien tletin [urnata mill- [urnata tal-pre\entata ta’ l-appell jew talba g]al revi\joni u g]andu jidde`iedi dwar il-kwistjoni mill-aktar fis possibbli.

(2) Il-Bord ta’ Revi\joni dwar il-Medi`ini g]andu jinforma lill-appellant, lill-Awtorità dwar il-Li`enzjar u lill-Awtorità dwar il- Medi`ini bl-opinjoni tieg]u bil-miktub malli jkun hekk prattikkabbli li jag]mel.

TAQSIMA III

DISPOSIZZJONIJIET {ENERALI

Titolu I - Awtorizzazzjoni ta’ Tqeg]id fis-Suq dwar Prodotti Medi`inali

19. (1) Id-disposizzjonijiet ta' l-artikoli 20 sa 36 g]andhom japplikaw g]al prodotti medi`inali li ji[u manifatturati b’mod industrjali g]all-u\u tal-bniedem u li jkunu inti\i li jitqeg]du fis-suq f’Malta.

(2) L-artikoli 20 sa 36 ma g]andhomx japplikaw g]al:
(a) prodott medi`inali ppreparat skond xi formula ma[istrali;
(b) prodott medi`inali ppreparat skond formola uffi`jali;
(`) prodotti medi`inali ma]suba g]al ri`erka u provi g]all-i\vilupp tag]hom;
(d) prodotti intermedji inti\i g]all-ippro`essar ulterjuri li jsir minn manifattur awtorizzat;
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(e) radjonuklidi fl-g]amla ta’ sorsi si[illati.

20. (1) }add ma g]andu jqieg]ed prodott medi`inali fis-suq f’Malta kemm-il darba ma jkollux awtorizzazzjoni ta’ tqeg]id fis-suq mill-Awtorità dwar il-Li`enzjar, skond id-disposizzjonijiet ta’ dan l- Att jew ta’ xi regolamenti jew regoli mag]mulin ta]tu:

I\da l-Awtorità dwar il-Li`enzjar tista’, f’ka\ijiet e``ezzjonali, tippermetti l-u\u ta’ xi prodott medi`inali ming]ajr l- awtorizzazzjoni ta’ tqeg]id fis-suq bla ]sara g]al dawk il- kondizzjonijiet li tista’ torbot ma’ dan:
I\da wkoll prodott medi`inali li jkun essenzjalment identiku ma’ prodott medi`inali li dwaru tkun di[à ng]atat awtorizzazzjoni g]at-tqeg]id fis-suq, g]andu biss ikun so[[ett g]al kondizzjonijiet li jistg]u ji[u stabbiliti mill-Awtorità dwar il- Li`enzjar.
(2) Applikazzjoni g]all-g]oti ta’ awtorizzazzjoni g]at-tqeg]id fis-suq g]andha ssir lill-Awtorità dwar il-Li`enzjar u g]andu jkun hemm id-dritt preskritt.
(3) L-applikazzjoni g]andu jkun fiha l-informazzjoni u d- dokumenti kollha me]tie[a g]all-valutazzjoni tas-sigurezza, l-kwalità u l-effika`ja tal-prodott medi`inali u g]andha tkun ippre\entata f’dik il-forma u b’dak il-mod hekk kif l-Awtorità dwar il-Li`enzjar tista’ b’regoli te]tie[.
(4) L-Awtorità dwar il-Li`enzjar g]andha tressaq l- applikazzjoni li tkun [iet ippre\entata lilha, quddiem l-Awtorità dwar il-Medi`ini mill-aktar fis possibbli.
(5) Meta applikazzjoni g]all-]ru[ ta’ awtorizzazzjoni ta’ tqeg]id fis-suq ti[i ri`evuta mill-Awtorità dwar il-Medi`ini, l- Awtorità tista’:
(a) tirrifjuta li tippro`essa l-applikazzjoni jekk dik l- applikazzjoni ma tkunx [iet ippre\entata skond id- disposizzjonijiet ta' dan l-Att;
(b) titlob lill-applikant jipprovdiha b’dik l- informazzjoni ulterjuri li tirrigwarda l-applikazzjoni li hija tista’ tqis me]tie[a; u meta ssir xi talba b]al dik, l-Awtorità dwar il- Medi`ini ma g]andhiex tkun me]tie[a tidde`iedi dwar l- applikazzjoni sakemm ma ti[ix hekk lilha ppre\entata l- informazzjoni hekk mitluba;
(`) tevalwa l-applikazzjoni dwar is-sigurezza, il-kwalità

Awtorizzazzjoni biex jitqieg]du prodotti medi`inali fis- suq.

A 160
u l-effika`ja ta’ prodott medi`inali b’dak il-mod u f’dak il- perjodu li jista’ ji[i ordnat b’dan l-Att jew ta]tu;
(d) twettaq kull attività o]ra li tista’ ti[i ordnata mill- Ministru minn \mien g]al \mien.

Revi\joni jew appell.

G]oti ta’ awtorizzazzjoni ta’ tqeg]id fis- suq.

Notifikazzjoni ta’ awtorizzazzjoni ta’ tqeg]id fis- suq.

(6) L-Awtorità dwar il-Medi`ini g]andha tirrapporta r- ri\ultanzi tag]ha u tag]mel ir-rakkomandazzjonijiet tag]ha lill- Awtorità dwar il-Li`enzjar, u tippre\enta kopja ta’ dawn lill- applikant, b’dak il-mod u f’dak il-perjodu li jista’ ji[i preskritt.

21. Meta l-Awtorità dwar il-Li`enzjar jew l-applikant ma jaqblux mar-ri\ultanzi jew mar-rakkomandazzjonijiet ta’ l-Awtorità dwar il-Medi`ini, kull parti tista’ tappella lill-Bord ta’ Revi\joni dwar il-Medi`ini bil-mod stabbilit b’dan l-Att jew ta]tu.

22. (1) Meta tir`ievi r-ri\ultanzi u r-rakkomandazzjonijiet ta’ l-Awtorità dwar il-Medi`ini, jew wara appell jew talba g]al revi\joni mill-Bord ta' Revi\joni dwar il-Medi`ini, l-Awtorità dwar il-Li`enzjar tista’ tirrifjuta jew xort’o]ra to]ro[ awtorizzazzjoni ta’ tqeg]id fis-suq jew skond ma ji[i rakkomandat mill-Awtorità dwar il- Medi`ini jew so[[etta g]al kull tali kondizzjoni jew obbligu li tista’ tqis li jkunu me]tie[a.

(2) Id-de`i\joni ta’ l-Awtorità dwar il-Li`enzjar g]andha tkun wa]da finali, u g]andha flimkien mar-ra[unijiet dettaljati li fuqhom tkun ibba\ata dik id-de`i\joni ti[i komunikata lill-Bord ta’ Revi\joni dwar il-Medi`ini, lill-Awtorità dwar il-Medi`ini u lill-applikant kif me]tie[.

23. (1) Sew meta ting]ata sew jekk xort’o]ra ma ting]atax awtorizzazzjoni ta’ tqeg]id fis-suq, l-Awtorità dwar il-Li`enzjar g]andha wkoll tg]arraf lill-Awtorità dwar il-Medi`ini b’dik id- de`i\joni.

(2) Awtorizzazzjoni ta’ tqeg]id fis-suq g]andha tispe`ifika:
(a) is-sommarju tal-karatteristi`i tal-prodott kif approvat;
(b) l-ittikkettjar u l-ippakkettjar approvat;
(`) kull kondizzjoni li tista’ tkun marbuta ma’ l-g]oti ta’
l-awtorizzazzjoni ta’ tqeg]id fis-suq;
(d) il-klassifikazzjoni tal-prodott medi`inali;
(e) i\-\mien ta’ validità ta’ l-awtorizzazzjoni ta’ tqeg]id
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fis-suq;
(f) kull spe`ifikazzjoni o]ra li l-Awtorità dwar il- Li`enzjar tista’ tqis li tkun me]tie[a.

24. (1) Kull awtorizzazzjoni ta’ tqeg]id fis-suq mog]tija ta]t dan l-Att g]andha, kemm-il darba ma tkunx [iet revokata qabel, tiskadi fi tmiem il-validità tag]ha.

(2) Kull awtorizzazzjoni ta’ tqeg]id fis-suq hekk mog]tija ta]t dan l-Att, kemm-il darba ma tkunx [iet revokata qabel, tkun tista’ ti[[edded wara li ssir applikazzjoni mid-detentur mill-anqas tliet xhur qabel l-iskadenza tal-perjodu ta’ validità.

25. (1) Meta applikazzjoni g]at-ti[did ta’ xi awtorizzazzjoni ta’ tqeg]id fis-suq ta]t dan l-Att tkun saret kif imiss, il-validità ta’ l-awtorizzazzjoni ta’ tqeg]id fis-suq g]andha titqies b]ala li tkun g]adha effettiva sakemm l-Awtorità dwar il-Li`enzjar tidde`iedi dwar l-applikazzjoni.

(2) Minkejja d-disposizzjonijiet ta' kull li[i o]ra, l-ebda qorti ma tista' to]ro[ mandat ta' inibizzjoni li jwaqqaf l-Awtorità dwar il- Li`enzjar milli tidde`iedi dwar dik l-applikazzjoni.
26. L-Awtorità dwar il-Li`enzjar g]andha tg]addi l- applikazzjoni g]al ti[did ta’ awtorizzazzjoni ta’ tqeg]id fis-suq lill- Awtorità dwar il-Medi`ini u f’kull ka\ b]al dan g]andhom jg]oddu, mutatis mutandis, id-disposizzjonijiet ta’ l-artikolu 20(4), (5), (6) u ta’ l-artikolu 21.

27. (1) L-Awtorità dwar il-Li`enzjar tista’ tirrifjuta li tag]ti jew i[[edded l-awtorizzazzjoni tat-tqeg]id fis-suq abba\i ta’ nuqqas ta’ kwalità, sigurezza jew effika`ja tal-prodott medi`inali jew fl- interess tas-sa]]a pubblika jew g]al xi ra[uni o]ra li normalment tkun ra[uni valida g]as-sospensjoni, ir-revoka, ir-rifjut jew ta’ xi awtorizzazzjoni xort’o]ra ta’ tqeg]id fis-suq:

I\da meta tag]mel dan l-Awtorità tal-Li`enzjar g]andha tinnotifika lill-Awtorità tal-Medi`ini u lill-applikant bid-de`i\joni tag]ha u tag]ti r-ra[unijiet dettaljati li fuqhom tkun motivata dik id- de`i\joni.
(2) Awtorizzazzjoni ta’ tqeg]id fis-suq m[eddha g]andha tispe`ifika:
(a) is-sommarju tal-karatteristi`i tal-prodott kif approvat;

Validità ta’ awtorizzazzjoni ta’ tqeg]id fis- suq.

Applikazzjoni g]al ti[did.

Notifikazzjoni ta’ rifjut ta’ ti[did.

Meta awtorizzazzjoni ta’ tqeg]id fis- suq ma ti[[eddidx.

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(b) l-ittikkettjar u l-ippakkettjar approvat;
(`) kull kondizzjoni li tista’ tkun marbuta ma’ l-g]oti ta’
l-awtorizzazzjoni ta’ tqeg]id fis-suq;
(d) il-klassifikazzjoni tal-prodott medi`inali;
(e) i\-\mien ta’ validità ta’ l-awtorizzazzjoni ta’ tqeg]id fis-suq;

Sospensjoni jew revoka ta’ awtorizzazzjoni ta’ tqeg]id fis- suq.

(f) kull spe`ifikazzjoni o]ra li l-Awtorità dwar il- Li`enzjar tista’ tqis li tkun me]tie[a.

28. (1) L-Awtorità dwar il-Li`enzjar g]andha tissospendi jew tirrevoka awtorizzazzjoni ta’ tqeg]id fis-suq ta’ xi prodott medi`inali meta dak il-prodott jirri\ulta li jkun dannu\ fil- kondizzjonijiet ta’ u\u normali tieg]u, jew meta ma jkollux effika`ja terapewtika, jew meta l-kompo\izzjonijiet tieg]u kemm kwalitattivi kemm kwantitattivi ma jkunux dawk dikjarati. G]all-fini ta’ dan l- artikolu jitqies li jkun hemm nuqqas ta’ effika`ja terapewtika meta ji[i stabbilit li ma jkunux jistg]u normalment jinkisbu ri\ultati terapewti`i mill-prodott medi`inali.

(2) Awtorizzazzjoni tkun ukoll sospi\a jew revokata meta jirri\ulta li l-partikolaritajiet b'sostenn ta’ l-applikazzjoni kif provdut dwarhom f’dan l-Att ma jkunux korretti jew ikunu [ew emendati ming]ajr awtorizzazzjoni jew meta l-kontrolli me]tie[a b’dan l-Att jew ta]tu ma jkunux [ew imwettqa.
(3) Meta l-ippakkettjar, ittikkettjar jew leaflet [o pakkett tal- prodott medi`inali inkwistjoni ma jkunux konformi mal-]ti[iet spe`ifikati b’dan l-Att jew ta]tu, l-Awtorità dwar il-Li`enzjar tista’ tissospendi l-awtorizzazzjoni ta’ tqeg]id fis-suq b’avvi\ li ji[i notifikat lid-detentur ta' l-awtorizzazzjoni g]at-tqeg]id fis-suq u s- sospensjoni g]andu jibqa’ jkollha effett sakemm l-Awtorità dwar il- Li`enzjar tkun sodisfatta li l-]ti[iet ikunu twettqu.
(4) Jekk l-Awtorità dwar il-Li`enzjar tissospendi jew tirrevoka awtorizzazzjoni ta’ tqeg]id fis-suq, din g]andha tav\a lid-detentur ta’ l-awtorizzazzjoni ta’ tqeg]id fis-suq u lill-Awtorità dwar il-Medi`ini b’dik id-de`i\joni fejn tag]ti b’mod dettaljat ir-ra[unijiet li fuqhom tkun motivata dik id-de`i\joni.
(5) Id-detentur ta' awtorizzazzjoni ta' tqeg]id fis-suq jista, fi
\mien erbatax-il [urnata minn dik in-notifika, jitlob lill-Bord ta' Revi\joni dwar il-Medi`ini biex je\amina `-`irkostanzi li wasslu g]as-sospensjoni jew revoka ta' l-awtorizzazzjoni g]at-tqeg]id fis- suq, u l-Bord ta' Revi\joni dwar il-Medi`ini g]andu jag]ti r-
A 163
rakkomandazzjoni tieg]u lill-Awtorità dwar il-Li`enzjar:
I\da din it-talba ma g]andhiex tissospendi l-effetti tad- de`i\joni ta' l-Awtorità dwar il-Li`enzjar u l-Awtorità dwar il- Li`enzjar ma tkunx marbuta bir-rakkomandazzjonijiet mag]mula mill-Bord ta' Revi\joni dwar il-Medi`ini.

29. (1) Meta ting]ata jew ti[i m[edda awtorizzazzjoni ta’ tqeg]id fis-suq, l-Awtorità dwar il-Li`enzjar g]andha tispe`ifika l- klassifikazzjoni tal-prodott medi`inali skond id-disposizzjonijiet ta’ dan l-Att, imma b’mod [enerali:

Klassifikazzjoni ta’ prodotti medi`inali.

jew
(a) fi prodott medi`inali so[[ett g]al ri`etta medi`inali;
(b) fi prodott medi`inali mhux so[[ett g]al ri`etta medi`inali, meta dak il-prodott medi`inali jitqies li jista’ jinbieg] jew ji[i fornut b’sigurezza ra[onevoli minn xi spi\jar jew ta]t is-supervi\joni tieg]u sakemm ma jkunx provdut b’dan l-Att li prodott medi`inali ta]t paragrafu (b) ta’ subartikolu (1) ji[i klassifikat ta]t paragrafu (a) ta’ subartikolu (1).
(2) L-Awtorità dwar il-Li`enzjar tista’ b’regoli tistabbilixxi t- tip, il-kontenut u l-pre\entazzjoni jew xort’o]ra ta’ xi ri`etta u min ikun awtorizzat li jo]ro[ dik ir-ri`etta li tista’ tkun me]tie[a g]al xi prodott medi`inali jew klassi ta’ prodotti medi`inali.

30. (1) L-Awtorità dwar il-Li`enzjar g]andha, mill-anqas ta’ kull sena, tippubblika fil-Gazzetta lista li tispe`ifika:

(a) il-prodotti medi`inali li jkollhom awtorizzazzjoni valida ta’ tqeg]id fis-suq;
(b) il-prodotti medi`inali li jistg]u jinbieg]u biss b'ri`etta; u
(`) meta dan ikun japplika, t-tip ta’ ri`etta me]tie[a u l- persuna jew persuni awtorizzati li jo]or[u dik ir-ri`etta.
(2) Kull meta tkun in]ar[et awtorizzazzjoni ta’ tqeg]id fis-suq dwar xi prodott medi`inali, l-Awtorità dwar il-Li`enzjar g]andha tippublika fil-Gazzetta l-informazzjoni spe`ifikata fis-subartikolu (1)(a), (b) u (`) u dik il-pubblikazzjoni g]andha titqies li tkun qeg]da temenda l-lista ta’ prodotti medi`inali ma]ru[a ta]t is-subartikolu (1).
(3) L-Awtorità dwar il-Li`enzjar g]andha tippublika fil- Gazzetta, malli jkun hekk prattikabbli li jsir, il-lista ta' prodotti medi`inali li dwarhom tkun [iet sospi\a jew revokata l-

Lista ta’ medi`ini li g]andhom awtorizzazzjoni ta’ tqeg]id fis- suq.

A 164

Reklamar ta’ prodotti medi`inali.

Prodotti medi`inali omeopati`i.

Prodotti li jinkisbu mid- demm tal- bniedem jew plasma tal- bniedem.

Prodotti medi`inali radjofarma`ewti

`i.

Prodotti medi`inali immunolo[i`i.

awtorizzazzjoni ta’ tqeg]id fis-suq u dik il-pubblikazzjoni g]andha titqies li tkun qeg]da temenda l-lista ta’ prodotti medi`inali ma]ru[a ta]t is-subartikolu (1).

31. Prodott medi`inali jista’ biss ji[i reklamat skond dawk il- kondizzjonijiet li jistg]u ji[u stabbiliti b’dan l-Att jew ta]tu.

32. Id-disposizzjonijiet ta’ din it-Taqsima g]andhom jg]addu g]al prodotti medi`inali omeopati`i g]all-u\u tal-bniedem ]lief g]al prodotti medi`inali omeopati`i li:

(a) ji[u amministrati mill-]alq u esternament, bla ]sara g]al dawk ir-regolamenti li jistg]u jsiru mill-Ministru dwarhom;
(b) ma jkollhom ebda indikazzjoni terapewtika spe`ifika li tidher fuq l-ittikkettjar tal-prodott medi`inali jew f’xi informazzjoni li jkollha x’taqsam ma’ dan; u
(`) jkollhom grad bi\\ejjed ta’ dilwizzjoni biex jiggarantixxi s-sigurezza tal-prodott medi`inali, b’mod partikolari, il-prodott medi`inali ma jistax ikun fih jew aktar minn taqsima wa]da minn kull 10,000 tat-tintura prin`ipali jew aktar minn wie]ed minn kull mija ta’ l-anqas do\a li tintu\a fl- allopatija g]ar-rigward ta’ elementi prin`ipali li l-pre\enza tag]hom fi prodott medi`inali allopatiku tirri\ulta fl-obbligu li ti[i ppre\entata ri`etta g]all-medi`ina.

33. Id-disposizzjonijiet ta’ din it-Taqsima g]andhom japplikaw g]al prodotti medi`inali bba\ati fuq kostitwenti tad-demm li ji[u m]ejjija industrijalment minn stabbiliment privat jew pubbliku, imma ma g]andhomx japplikaw g]al demm, plasma jew `elluli tad- demm li jori[inaw mill-bniedem.

34. L-awtorizzazzjoni ta’ tqeg]id fis-suq imsemmija fl- artikolu 20 g]andha tkun me]tie[a g]al [eneraturi, apparat, prekursuri ta’ radjofarma`ewti`i u radjofarma`ewti`i ppreparati industrijalment, ]lief g]al prodotti radjofarma`ewti`i li ji[u ppreparati fil-waqt ta’ l-u\u tag]hom minn persuna jew minn stabbiliment awtorizzat, ta]t dan l-Att, biex ju\a dawk il-prodotti medi`inali fi stabbiliment approvat g]all-kura tas-sa]]a esklu\ivament minn [eneraturi, apparat jew prekursuri ta’ radjofarma`ewti`i awtorizzati skond l-istruzzjonijiet tal-manifattur.

35. (1) Id-disposizzjonijiet ta’ din it-Taqsima g]andhom jg]oddu g]al prodotti medi`inali immunolo[i`i.

(2) L-Awtorità dwar il-Li`enzjar tista’ tippreskrivi regoli biex
A 165
tirregola l-]ru[ jew xort’o]ra ta’ xi awtorizzazzjoni ta’ tqeg]id fis- suq g]al prodotti medi`inali immunolo[i`i.

36. (1) Id-disposizzjonijiet ta’ din it-Taqsima g]andhom jg]oddu g]al prodotti medi`inali erbali minbarra prodotti medi`inali erbali ppreparati skond formola ma[istrali jew uffi`jali.

(2) L-Awtorità dwar il-Li`enzjar tista’ tippreskrivi regoli biex tirregola l-]ru[ jew xort’o]ra ta’ xi awtorizzazzjoni ta’ tqeg]id fis- suq g]al prodotti medi`inali erbali.

Titolu II - Manifattura ta’ Prodotti Medi`inali g]all-U\u tal-Bniedem

37. Ming]ajr pre[udizzju g]al kull e\enzjoni li tista’ ti[i mog]tija ta]t dan l-Att, ]add ma g]andu jimmanifattura, jag]mel assembla[[ jew b’xi mod jibdel xi prodott medi`inali ]lief skond li`enza ta’ manifattur ma]ru[a skond id-disposizzjonijiet ta’ dan l-Att jew regolamenti jew regoli mag]mulin ta]tu:

I\da tali li`enza ma g]andhiex tkun me]tie[a g]all- preparazzjoni, qsim, tibdil fl-ippakkettjar jew fil-pre\entazzjoni meta dawn il-pro`essi ji[u mwettqa g]all-fini ta’ bejg] jew amministrazzjoni skond ma hu pprovdut ta]t dan l-Att.

38. (1) Applikazzjoni g]all-g]oti ta’ li`enza g]all- manifattura, assembla[[ jew tibdil ta’ prodott medi`inali g]andha ssir lill-Awtorità dwar il-Li`enzjar u g]andu jkun fiha dik l- informazzjoni, dokumenti, kampjuni u materjal ie]or li jista’ jkun provdut b’dan l-Att jew ta]tu:

I\da dik l-applikazzjoni g]andha tindika dan li [ej:
(a) l-isem tal-prodott medi`inali u l-forma jew il-forom farma`ewti`i, li jkun se ji[i manifatturat, isir l-assembla[[ tieg]u jew b’xi mod isirlu tibdil;
(b) il-post fejn tkun se ssir dik l-attività, u dik l- informazzjoni u dokumentazzjoni li jkunu me]tie[a sabiex jintwera li dak il-post ikun wie]ed adatt u suffi`jenti g]al dak l- g]an;
(`) it-tag]mir u l-fa`ilitajiet ta’ kontroll li huma me]tie[a b’dan l-Att jew ta]tu;
(d) l-isem u indirizz ta’ l-applikant;
(e) l-isem ta’ mill-inqas persuna kwalifikata wa]da li g]andha tkun professjonalment responsabbli g]all-attività, u dik

Prodotti medi`inali erbali.

Li`enza ta’

manifattur.

Applikazzjoni g]al li`enza ta’ manifattur.

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il-persuna g]andu jkollha l-kwalifiki li ji[u preskritti:
I\da meta ti[i nominata aktar minn persuna kwalifikata wa]da, l-applikazzjoni g]andha turi b’mod `ar ir- responsabbiltajiet spe`ifi`i ta’ kull persuna;
(f) kull informazzjoni, dokumentazzjoni jew prova o]ra li tista’ tintalab mill-Awtorità dwar il-Li`enzjar skond jew ta]t dan l-Att.
(2) L-Awtorità dwar il-Li`enzjar g]andha tidde`iedi dwar l- applikazzjoni fil-perjodu ta’ \mien li jista’ ji[i stabbilit ta]t dan l-Att:

G]oti ta’ li`enza ta ’ manifattur.

Avvi\ dwar informazzjoni ulterjuri.

Sospensjoni jew revoka ta’ li`enza ta’ manifattur.

I\da dan il-perjodu jista' ji[i sospi\ sakemm ting]ata l- informazzjoni rilevanti.

39. (1) L-Awtorità dwar il-Li`enzjar g]andha, qabel ma tidde`iedi dwar applikazzjoni, tispezzjona l-fond indikat fi- applikazzjoni u ma g]andhiex to]ro[ li`enza kemm-il darba ma tkunx sodisfatta li dak il-fond jkun konformi mal-]ti[iet stabbiliti b’dan l- Att jew ta]tu:

I\da li`enza tista’ ting]ata bil-kondizzjoni li jitwettqu dawk l-obbligi li jistg]u ji[u imposti fiha.
(2) Il-li`enza ta’ manifattur g]andha tispe`ifika l-fond u l- prodotti medi`inali u l-forma jew forom farma`ewti`i li g]alihom tirreferi.
(3) Id-detentur ta’ li`enza g]andu ji\gura li l-attività ti[i mwettqa skond id-disposizzjonijiet ta’ dan l-Att u ta’ regolamenti mag]mulin ta]tu.

40. Meta l-Awtorità dwar il-Li`enzjar jidhrilha li jistg]u je\istu `irkostanzi li jirrendu me]tie[a l-konsiderazzjoni ta’ jekk g]andhiex ti[i mibdula, sospi\a jew revokata l-li`enza, l-Awtorità dwar il-Li`enzjar tista’ tinnotifika lid-detentur ta’ li`enza ta’ manifattur avvi\ li jkun je]tie[u biex, fi \mien li jista’ ji[i spe`ifikat fl-avvi\, jipprovdiha b’kull informazzjoni spe`ifikata fl-avvi\.

41. (1) L-Awtorità dwar il-Li`enzjar tista’ tissospendi li`enza ta’ manifattur ta]t dan l-Att g]al dak il-perjodu li tista’ tistabbilixxi, jew tista’ tirrevoka, jew tibdel id-disposizzjonijiet ta’ xi tali li`enza.

(2) Il-poteri vestiti fis-subartikolu (1) g]andhom ji[u biss e\er`itati f’xi `irkostanzi minn dawn li [ejjin:
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(a) meta l-]wejje[ dikjarati fl-applikazzjoni li abba\i tag]ha tkun ing]atat il-li`enza kienu foloz jew inkompleti f’xi dettal partikolari;
(b) meta jkun [ara bdil materjali ta’ `irkostanzi dwar xi
]a[a minn dawk il-]wejje[;
(`) meta tkun inkisret xi kondizzjoni tal-li`enza;
(d) meta ma jkunux t]arsu l-]ti[iet dwar il-li`enzi kif stabbiliti b’dan l-Att jew ta]tu;
(e) meta l-pro`essi ta’ manifattura jew assembla[[ ta’ xi prodott medi`inali jitwettqu b’mod mhux konformi mad- disposizzjonijiet ta’ l-awtorizzazzjoni ta’ tqeg]id fis-suq ta’ dak il-prodott medi`inali;
(f) ma jkunux qeg]din jit]arsu l-kondizzjonijiet dwar prattika ta’ manifattura kif dovuta; u
(g) f’xi `irkostanza o]ra li tista’ ti[i stabbilita b’dan l- Att jew ta]tu.

42. (1) L-Awtorità dwar il-Li`enzjar g]andha twettaq spezzjonijiet regolari biex ti\gura li ji[u m]arsa l-]ti[iet stabbiliti b’dan l-Att jew ta]tu dwar il-manifattura, l-assembla[[ jew il- modifikazzjoni ta’ xi prodott medi`inali.

(2) L-Awtorità dwar il-Li`enzjar jew persuna li tkun qed tag]mel spezzjoni g]andha:
(a) tispezzjona l-istabbiliment ta’ manifattura u kull post ie]or skond ma jista’ jkun me]tie[;
(b) te\amina kull dokument rilevanti;
(`) tie]u kampjuni skond ma jista’ jkun me]tie[;
(d) tabbozza rapport tar-ri\ultanzi, u tikkomunika l- kontenut ta’ dak ir- rapport lid-detentur ta’ li`enza jew lil applikant g]al li`enza dwar dak l-ispezzjoni u lil-persuna kwalifikata;
(e) twettaq kull attività o]ra li tista’ tqis li tkun adatta g]all-e\ekuzzjoni ta’ dmirijietha u r-responsabbiltajiet tag]ha kif imiss u kif provdut b’dan l-Att jew ta]tu.
(3) }lief f'ka\ijiet ur[enti, kull spezzjoni g]andha ti[i

Spezzjoni fir- rigward ta’ manifattur, e``.

A 168

G]al kemm

\mien iddum u

ti[did ta’ li`enza ta’ manifattur.

Responsabbil- tajiet ta’ detentur ta’ li`enza ta’ manifattur.

mwettqa fil-pre\enza ta’ persuna kwalifikata jew ir-rappre\entant tieg]u, jekk ikun hemm.

43. (1) Bla ]sara g]ad-disposizzjonijiet ta’ dan l-Att, kull li`enza mog]tija ta]t din it-Taqsima g]andha, kemm-il darba ma tkunx [iet qabel im[edda jew revokata, tiskadi fi tmiem il-validità tag]ha.

(2) Kull li`enza hekk mog]tija g]andha, kemm-il darba ma tkunx [iet revokata qabel, ti[[edded billi ssir applikazzjoni mid- detentur ta’ li`enza mill-anqas tliet xhur qabel l-iskadenza tal-perjodu ta’ validità.
(3) L-Awtorità dwar il-Li`enzjar tista’ b’regoli tistabbilixxi l- perjodu ta’ validità ta’ li`enza ma]ru[a ta]t din it-Taqsima.
(4) Meta ssir applikazzjoni lill-Awtorità dwar il-Li`enzjar g]at-ti[did ta’ li`enza ta]t din it-Taqsima, l-Awtorità dwar il- Li`enzjar:
(a) tista’ [[edded il-li`enza, kemm b’modifikazzjonijiet kemm ming]ajrhom, g]al dak il-perjodu ulterjuri li jista’ jkun spe`ifikat; jew
(b) jekk, wara li tqis id-disposizzjonijiet ta’ dan l-Att, tqis li jkun me]tie[ jew spedjenti li hekk isir, tista’ tirrifjuta li [[edded il-li`enza.
(5) Id-disposizzjonijiet ta' l-artikoli 25, 39 u 40 g]andhom jg]oddu g]al applikazzjonijiet b]al dawn.

44. Ikun id-dmir ta’ detentur ta’ li`enza ta’ manifattur -

(a) li minnufih jinforma lill-Awtorità dwar il-Li`enzjar dwar kull tibdil tal-persuna kwalifikata;
(b) li jipprovdi lil uffi`jali awtorizzati b’a``ess g]all- fond tieg]u f’kull ]in ra[onevoli;
(`) li jag]mel possibbli li l-persuna kwalifikata tkun tista’ taqdi dmirijietha kif stabbilit minn jew ta]t dan l-Att;
(d) li j\omm dawk ir-records g]al kull operazzjoni li ssir fi prodotti medi`inali b]alma jista’ ji[i stabbilit b’dan l-Att jew ta]tu u jara li dawk ir-records ikunu disponibbli g]all- ispezzjon minn kull uffi`jal awtorizzat g]al dak il-perjodu ta’
\mien skond ma jkun jen]tie[ b’dan l-Att jew ta]tu;
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(e) li jkollu g]ad-disposizzjoni tieg]u s-servizzi ta’ impjegati sabiex jissodisfa il-]ti[iet stabbiliti minn jew ta]t dan l-Att rigward manifattura, assembly jew modifikazzjoni ta’ prodotti medi`inali;
(f) li japplika lill-Awtorità dwar il-Li`enzjar dwar kull tibdil propost jew modifikazzjoni rigward il-li`enza;
(g) illi josserva r-regolamenti jew Ordnijiet dwar il- prattika tajba ta’ manifattura stabbiliti minn jew ta]t dan l-Att jew ta]t xi ligi o]ra;
(h) li jiddisponi minn prodotti medi`inali kif stabbilit minn jew ta]t dan l-Att jew ta]t xi li[i o]ra;
(i) responsabbiltajiet o]ra li jistg]u jkunu stabbiliti minn \mien g]al \mien minn jew ta]t dan l-Att.

45. (1) Ir-responsabbiltajiet ta’ persuna kwalifikata jkunu:

(a) li ti\gura li standards ta’ prattika tajba fil- manifattura ji[u m]arsa f’kull waqt;
(b) li ti\gura li kull lott ta' prodotti medi`inali jkun [ie manifatturat, ittestjat u jkun konformi f’kull rigward ma’ kull
]tie[a stabbilita b’dan l-Att jew ta]tu; u
(`) li ti\gura li kull lott ta' prodotti medi`inali jkun [ie manifatturat skond il-]ti[iet ta’ l-awtorizzazzjoni ta’ tqeg]id fis-suq.
(2) Il-persuna kwalifikata g]andha tkun pre\enti fil-fond f’kull waqt meta tkun qeg]da ssir l-attività:
I\da l-persuna kwalifikata tista’ tinnomina persuna li tkun kwalifikata b]alha biex ta[ixxi b]ala r-rappre\entant tag]ha.
(3) Meta l-persuna kwalifikata tkun innominat rappre\entant kif hawn qabel imsemmi, hi g]andha minnufih tinforma lill-Awtorità dwar il-Li`enzjar b’dik in-nomina.

46. L-Awtorità dwar il-Li`enzjar, tista’ jekk ikollha suspett ra[onevoli li xi persuna kwalifikata tkun qed ta[ixxi bi ksur ta’ xi disposizzjoni ta’ dan l-Att, tissospendi l-attività ta’ dik il-persuna kwalifikata b'avvi\ bil-miktub fejn tispe`ifika r-ra[unijiet g]al dik is- sospensjoni sakemm dik il-persuna tkun irrimedjat kull nuqqas li [ie indikat lilha mill-Awtorità dwar il-Li`enzjar.

Responsabbil- tajiet tal-persuna kwalifikata.

Sospensjoni ta’ attività ta’ persuna kwalifikata.

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Bdil fil- kondizzjonijiet ta’ li`enza ta’ manifattur.

Obbligi ta’ l- Awtorità dwar il-Li`enzjar.

Manifattura ta’ prodotti medi`inali omeopati`i.

Manifattura ta’ prodotti medi`inali li jinkisbu mid- demm tal- bniedem u plasma tal- bniedem, e``.

Manifattura ta’

radjofarma`ewti

`i.

Prodotti medi`inali immunolo[i`i.

Prodotti medi`inali erbali.

Negozju bl- ingrossa.

47. L-Awtorità dwar il-Li`enzjar tista’, wara li ssir applikazzjoni mid-detentur ta' li`enza g]al hekk, tibdel il- kondizzjonijiet tal-li`enza jekk din tkun sodisfatta li dik il-varjazzjoni ma tkunx se tolqot avversment standards ta’ prattika tajba fil- manifattura skond kif jista’ ji[i preskritt.
48. L-Awtorità dwar il-Li`enzjar tista' tvarja, tissospendi, tirrevoka jew tirrifjuta milli [[edded li`enza ta’ manifattur, jew tista' tg]addi l-kwistjoni lill-Awtorità dwar il-Medi`ini u f'kull ka\ b]al dan g]andhom jg]oddu, mutatis mutandis, id-disposizzjonijiet ta' l- artikolu 20(4), (5) u (6) u ta' l-artikolu 21.

49. Ming]ajr pre[udizzju g]all-artikolu 32, id- disposizzjonijiet ta’ l-artikoli 37 sa 48 g]andhom jg]oddu g]all- manifattura u l-assembla[[ ta’ prodotti medi`inali omeopati`i, minbarra l-prodotti elenkati fl-artikolu 32(a), (b) u (`).

50. Ming]ajr pre[udizzju g]all-artikolu 33, id- disposizzjonijiet ta’ l-artikoli 37 sa 48 u ta’ regolamenti mag]mulin ta]thom g]andhom jg]oddu g]all-manifattura u l-assembla[[ ta’ prodotti medi`inali li jinkisbu mid-demm tal-bniedem u plasma tal- bniedem, minbarra l-prodotti elenkati fl-artikolu 32(a), (b) u (`).

51. Ming]ajr pre[udizzju g]all-artikolu 34, id- disposizzjonijiet ta’ l-artikoli 37 sa 48 u ta’ regolamenti mag]mulin ta]thom g]andhom jg]oddu g]all-manifattura u l-assembla[[ ta’ prodotti radjofarma`ewti`i, minbarra l-prodotti elenkati fl-artikolu

32(a), (b) u (`).

52. Ming]ajr pre[udizzju g]all-artikolu 35, id- disposizzjonijiet ta’ l-artikoli 37 sa 48 u ta’ regolamenti mag]mulin ta]thom g]andhom jg]oddu g]all-manifattura u l-assembla[[ ta’ prodotti medi`inali immunolo[i`i, minbarra l-prodotti elenkati fl- artikolu 32(a), (b) u (`).

53. Ming]ajr pre[udizzju g]all-artikolu 36, id- disposizzjonijiet ta’ l-artikoli 37 sa 48 u ta’ regolamenti mag]mulin ta]thom g]andhom jg]oddu g]all-manifattura u l-assembla[[ta’ prodotti medi`inali erbali, minbarra l-prodotti elenkati fl-artikolu

32(a), (b) u (`).

Titolu III - Distribuzzjoni bl-Ingrossa ta’ Prodotti Medi`inali g]all-U\u tal-Bniedem

54. (1) Ming]ajr pre[udizzju g]al kull e\enzjoni li tista’ tkun mog]tija b’dan l-Att jew ta]tu, ]add ma g]andu j]addem negozju bl-ingrossa f'xi prodott medi`inali ]lief jekk ikun id-detentur ta' li`enza ta’ negozjant bl-ingrossa ma]ru[a skond id- disposizzjonijiet ta’ dan l-Att u ]lief jekk il-prodott medi`inali jkun

A 171
ing]ata awtorizzazzjoni ta’ tqeg]id fis-suq mill-Awtorità dwar il- Li`enzjar.
(2) Id-distribuzzjoni bl-ingrossa ta’ prodott medi`inali permezz ta’ negozju bl-ingrossa g]andha ssir biss mill-post spe`ifikat fil-li`enza u skond il-kondizzjonijiet ta’ l-istess li`enza.

55. (1) Applikazzjoni g]all-g]oti ta’ li`enza ta' negozjant bl-ingrossa g]andha ssir lill-Awtorità dwar il-Li`enzjar u g]andu jkun fiha dik l-informazzjoni, dokumenti, kampjuni u materjal ie]or li jista’ jkun provdut b’dan l-Att jew ta]tu:

I\da dik l-applikazzjoni g]andha tindika dan li [ej: (a) l-isem u indirizz ta’ l-applikant;
(b) l-indirizz tal-post li se jintu\a g]all-g]anijiet tad- distribuzzjoni bl-ingrossa;
(`) it-tag]mir u l-fa`ilitajiet ta’ kontroll li huma me]tie[a b’dan l-Att jew ta]tu;
(d) l-informazzjoni, d-dokumentazzjoni u l-prova biex ji[i ppruvat li l-post hu adatt u adegwat, u li hemm fa`ilitajiet, istallazzjonijiet u tag]mir adatti, biex ti[i \gurata l- konservazzjoni u d-distribuzzjoni xierqa ta' prodotti medi`inali;
(e) l-isem ta’ mill-anqas persuna wa]da responsabbli jew kwalifikata li g]andha tkun professjonalment responsabbli g]all-attività, u dik il-persuna g]andu jkollha l-kwalifiki li ji[u perskritti:
I\da meta ti[i nominata aktar minn persuna responsabbli jew kwalifikata wa]da, l-applikazzjoni g]andha turi b’mod `ar ir-responsabbiltajiet spe`ifi`i ta’ kull persuna;
(f) kull informazzjoni, dokumentazzjoni jew prova o]ra li tista’ tintalab mill-Awtorità dwar il-Li`enzjar skond jew ta]t dan l-Att.
(2) L-Awtorità dwar il-Li`enzjar g]andha tidde`iedi dwar l- applikazzjoni fil-perjodu ta’ \mien li jista’ ji[i stabbilit ta]t dan l-Att:
I\da dan il-perjodu jista' ji[i sospi\ sakemm ting]ata l- informazzjoni rilevanti.

56. (1) L-Awtorità dwar il-Li`enzjar g]andha, qabel ma tidde`iedi dwar applikazzjoni, tispezzjona l-fond indikat fi-

Applikazzjoni g]al li`enza ta’ negozjant bl- ingrossa.

G]oti ta’ li`enza ta’ negozjant bl- ingrossa.

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applikazzjoni u ma g]andhiex to]ro[ li`enza kemm-il darba ma tkunx sodisfatta li dak il-fond jkun konformi mal-]ti[iet stabbiliti b’dan l- Att jew ta]tu:
I\da li`enza tista’ ting]ata bil-kondizzjoni li jitwettqu dawk l-obbligi li jistg]u ji[u imposti fiha.
(2) Il-li`enza ta’ negozjant bl-ingrossa g]andha tispe`ifika l- fond u l-attivitajiet li g]alihom tirreferi.

Avvi\ dwar informazzjoni ulterjuri.

G]al kemm

\mien iddum u

ti[did ta’ li`enza ta’ negozjant bl- ingrossa.

(3) Id-detentur ta’ li`enza g]andu ji\gura li l-attività ti[i mwettqa skond id-disposizzjonijiet ta’ dan l-Att u ta’ regolamenti mag]mulin ta]tu.

57. Meta l-Awtorità dwar il-Li`enzjar jidhrilha li jistg]u je\istu `irkostanzi li jirrendu me]tie[a l-konsiderazzjoni ta’ jekk g]andhiex ti[i mibdula, sospi\a jew revokata l-li`enza, l-Awtorità dwar il-Li`enzjar tista’ tinnotifika lid-detentur ta’ li`enza ta’ negozjant bl-ingrossa avvi\ li jkun je]tie[u biex, fi \mien li jista’ ji[i spe`ifikat fl-avvi\, jipprovdiha b’kull informazzjoni spe`ifikata fl- avvi\.

58. (1) Bla ]sara g]ad-disposizzjonijiet ta’ dan l-Att, kull li`enza mog]tija ta]t din it-Taqsima g]andha, kemm-il darba ma tkunx [iet qabel im[edda jew revokata, tiskadi fi tmiem il-validità tag]ha.

(2) Kull li`enza hekk mog]tija g]andha, kemm-il darba ma tkunx [iet revokata qabel, ti[[edded billi ssir applikazzjoni mid- detentur ta’ li`enza mill-anqas tliet xhur qabel l-iskadenza tal-perjodu ta’ validità.
(3) L-Awtorità dwar il-Li`enzjar tista’ b’regoli tistabbilixxi l- perjodu ta’ validità ta’ li`enza ma]ru[a ta]t din it-Taqsima.
(4) Meta ssir applikazzjoni lill-Awtorità dwar il-Li`enzjar g]at-ti[did ta’ li`enza ta]t din it-Taqsima, l-Awtorità dwar il- Li`enzjar:
(a) tista’ [[edded il-li`enza, kemm b’modifikazzjonijiet kemm ming]ajrhom, g]al dak il-perjodu ulterjuri li jista’ jkun spe`ifikat; jew
(b) jekk, wara li tqis id-disposizzjonijiet ta’ dan l-Att, tqis li jkun me]tie[ jew spedjenti li hekk isir, tista’ tirrifjuta li [[edded il-li`enza.
(5) Id-disposizzjonijiet ta' l-artikoli 25, 39 u 40 g]andhom
A 173
jg]oddu g]al applikazzjonijiet b]al dawn.

59. Ikun id-dmir ta’ detentur ta’ li`enza ta’ negozjant bl- ingrossa -

(a) li minnufih jinforma lill-Awtorità dwar il-Li`enzjar dwar kull tibdil tal-persuna kwalifikata jew responsabbli;
(b) li jipprovdi lil uffi`jali awtorizzati b’a``ess g]all- fond tieg]u f’kull ]in ra[onevoli;
(`) li jag]mel possibbli li l-Awtorità dwar il-Li`enzjar tkun tista’ taqdi dmirijietha kif stabbiliti b’dan l-Att jew ta]tu;
(d) li j\omm dawk ir-records g]al kull operazzjoni li ssir fi prodotti medi`inali b]alma jista’ ji[i stabbilit b’dan l-Att jew ta]tu u jara li dawk ir-records ikunu disponibbli g]all- ispezzjon minn kull uffi`jal awtorizzat g]al dak il-perjodu ta’
\mien skond ma jkun jen]tie[ b’dan l-Att jew ta]tu.
60. (1) Il-persuna responsabbli g]andha ti\gura li ji[u m]arsa f’kull waqt standards ta’ prattika tajba fid-distribuzzjoni bl- ingrossa skond kif jista’ ji[i preskritt.
(2) Il-persuna kwalifikata jew responsabbli g]andha tkun pre\enti fil-fond f’kull waqt meta tkun qieg]da ssir l-attività li`enzjata:
I\da l-persuna kwalifikata jew responsabbli tista’
tinnomina persuna o]ra biex ta[ixxi b]ala r-rappre\entant tag]ha.
(3) Meta l-persuna kwalifikata jew responsabbli tkun innominat rappre\entant kif hawn qabel imsemmi, hi g]andha minnufih tinforma lill-Awtorità dwar il-Li`enzjar b’dik in-nomina.

61. L-Awtorità dwar il-Li`enzjar tista’ tissospendi il-li`enza ta’ negozjant bl-ingrossa mog]tija ta]t dan l-Att g]al dak l- perjodu li din tista’ tistabbilixxi, jew tista’ tirrevoka, jew tibdel id- disposizzjonijiet ta’ xi li`enza b]al dik f'kull wie]ed mill-ka\ijiet li [ejjin:

(a) meta l-]wejje[ dikjarati fl-applikazzjoni li abba\i tag]ha tkun in]ar[et il-li`enza kienu foloz jew inkompleti f’xi materjal partikolari;
(b) meta jkun hemm bdil materjali ta’ `irkostanzi dwar xi ]a[a minn dawk;
(`) meta tkun inkisret xi kondizzjoni tal-li`enza;

Obbligi ta’ detentur ta’ li`enza ta’ negozjant bl- ingrossa.

Ir- responsabbiltà li g]andhom il- persuni responsabbli.

Sospensjoni jew revoka ta’ li`enza ta’ negozjant bl- ingrossa.

A 174
(d) meta ma jkunux t]arsu l-]ti[iet dwar il-li`enza kif stabbiliti b’dan l-Att jew ta]tu;
(e) meta ma jkunux qeg]din jit]arsu l-kondizzjonijiet ta’ prattika tajba dwar id-distribuzzjoni bl-ingrossa; u

Bdil fil- kondizzjonijiet ta’ li`enza ta’ negozjant bl- ingrossa.

Obbligi ta’ l- Awtorità dwar il-Li`enzjar.

Spezzjonar dwar bejg] bl- ingrossa.

Disposizzjonijie t spe`jali.

(f) f’kull `irkostanza o]ra li tista’ ti[i stabbilita b’dan l- Att jew ta]tu.

62. L-Awtorità dwar il-Li`enzjar tista’, wara li ssir applikazzjoni mid-detentur ta' li`enza g]al hekk, tibdel il- kondizzjonijiet tal-li`enza jekk din tkun sodisfatta li dik il-varjazzjoni ma tkunx se tolqot avversment standards ta’ prattika tajba fid- distribuzzjoni bl-ingrossa.

63. L-Awtorità dwar il-Li`enzjar tista' tvarja, tissospendi, tirrevoka jew tirrifjuta milli [[edded li`enza ta’ negozjant bl- ingrossa, jew tista' tg]addi l-kwistjoni lill-Awtorità dwar il-Medi`ini u f'kull ka\ b]al dan g]andhom jg]oddu, mutatis mutandis, id- disposizzjonijiet ta' l-artikolu 20(4), (5) u (6) u ta' l-artikolu 21.

64. (1) L-Awtorità dwar il-Li`enzjar g]andha ti\gura li ji[u m]arsa l-]ti[iet stabbiliti b’dan l-Att jew ta]tu dwar in-negozju bl- ingrossa ta’ xi prodott medi`inali.

(2) L-Awtorità dwar il-Li`enzjar g]andha:
(a) tispezzjona l-istabbiliment tan-negozju bl-ingrossa u kull imkien ie]or li tista’ tqies li jkun me]tie[;
(b) te\amina kull dokument li jirrigwarda l-ispezzjon; (`) tie]u kull kampjun li tista’ tqies li jkun me]tie[;
(d) tag]mel rapport dwar ir-ri\ultanzi, li g]andu jitwassal kemm lid-detentur ta’ li`enza jew lill-applikant g]al li`enza dwar dik l-ispezzjon kemm lill-persuna responsabbli;
(e) tag]mel kull attività o]ra li tista’ titqies adatta g]all- e\ekuzzjoni ta’ dmirijietha u r-responsabbiltajiet tag]ha kif imiss u kif provdut b’dan l-Att jew ta]tu.

65. Ming]ajr pre[udizzju g]ad-disposizzjonijiet ta’ din it- Taqsima, l-Awtorità dwar il-Li`enzjar tista’ b’regoli tistabbilixxi

]ti[iet addizzjonali g]ad-distribuzzjoni bl-ingrossa ta’: (a) sustanzi narkoti`i jew psikotropi`i;
(b) prodotti medi`inali li jinkisbu mid-demm;
A 175
(`) prodotti medi`inali immunolo[i`i; (d) radjofarma`ewti`i;
(e) dawk il-prodotti medi`inali l-o]ra jew klassi jew klassijiet ta’ prodotti medi`inali li l-Ministru jista’ jordna.

Titolu IV - Spi\eriji u Attività Farma`ewtika relatata

66. (1) }add ma jista’ jifta] jew i\omm spi\erija kemm-il darba ma jkollux li`enza ta’ spi\erija ma]ru[a skond id- disposizzjonijiet ta’ dan l-Att jew regolamenti mag]mulin ta]tu.

(2) Li`enzi ta’ spi\eriji g]andhom jin]ar[u skond kriterji [eo- demografi`i stabbiliti permezz ta’ regolamenti ta]t dan l-Att.
(3) Regolamenti ta]t dan l-artikolu m’g]andhomx isiru kemm- il darba l-Ministru ma jkunx qabel ippubblika l-abbozz tag]hom fil- Gazzetta tal-Gvern fejn jippermetti lil kull persuna perjodu ta’ mill- anqas erba’ [img]at biex tag]mel rappre\entazzjoni bil-miktub lill- Ministru.
(4) Il-Ministru g]andu jitlob lill-Awtorità tal-Li`enzjar sabiex tag]mel rapport dwar ir-rappre\entazzjonijiet imsemmija fis- subartikolu pre`edenti wara li tisma’ lil dawk il-persuni jew tie]u dak il-parir espert li tikkonsidra spedjenti, flimkien ma’ kull opinjoni o]ra li jista’ jkollha dwar l-abbozz ippubblikat ta]t is-subartikolu (2), u l- Ministru jista’ meta jir`ievi r-rapport ming]and l-Awtorità jippro`edi biex jirrevedi l-abbozz tar-regolamenti u jippromulga dawk ir- regolamenti skond dik ir-revi\joni.
(5) Ming]ajr pre[udizzju g]al kull e\enzjoni li tista’ tkun mog]tija b’dan l-Att jew ta]tu, ]add ma g]andu jbieg] bl-imnut xi prodott medi`inali ]lief skond li`enza ta’ spi\erija ma]ru[a skond id- disposizzjonijiet ta’ dan l-Att jew regolamenti jew xi regoli mag]mulin ta]tu.
(6) Id-detentur ta’ li`enza jkun responsabbli biex i]ares il- kondizzjonijiet tal-li`enza li jistg]u ji[u stabbiliti b’dan l-Att jew ta]tu.

67. (1) Applikazzjoni g]all-g]oti ta’ li`enza ta' spi\erija g]andha ssir lill-Awtorità dwar il-Li`enzjar u g]andu jkun fiha dik l- informazzjoni, dokumenti, kampjuni u materjal ie]or li jista’ jkun provdut b’dan l-Att jew ta]tu:

I\da dik l-applikazzjoni g]andha tindika dan li [ej:

Li`enza biex tinfeta] spi\erija.

Applikazzjoni g]al li`enza ta’ spi\erija.

A 176
(a) l-isem u indirizz ta’ l-applikant;
(b) l-indirizz tal-fond li g]andu jintu\a g]all-fini tal- bejg] bl-imnut ta’ prodotti medi`inali;
(`) it-tag]mir u l-fa`ilitajiet ta’ kontroll li huma me]tie[a b’dan l-Att jew ta]tu;
(d) l-informazzjoni, id-dokumentazzjoni u l-prova biex ji[i ppruvat li l-post hu adatt u adegwat, u li hemm fa`ilitajiet, installazzjonijiet u tag]mir adatti, biex ti[i \gurata l- konservazzjoni u dispensa ta’ prodotti medi`inali;
(e) l-isem ta’ spi\jar responsabbli li g]andu jkun professjonalment responsabbli g]all-attivitajiet kollha;
(f) kull informazzjoni, dokumentazzjoni jew prova o]ra li tista’ tintalab mill-Awtorità dwar il-Li`enzjar skond jew ta]t dan l-Att.
(2) L-Awtorità dwar il-Li`enzjar g]andha tidde`iedi dwar l- applikazzjoni fil-perjodu ta’ \mien li jista’ ji[i stabbilit ta]t dan l-Att:

G]oti ta’ li`enza ta’ spi\erija.

Avvi\ dwar informazzjoni ulterjuri.

I\da dan il-perjodu jista' ji[i sospi\ sakemm ting]ata l- informazzjoni rilevanti.

68. (1) L-Awtorità dwar il-Li`enzjar g]andha, qabel ma tidde`iedi dwar applikazzjoni, tispezzjona l-fond indikat fi- applikazzjoni u ma g]andhiex to]ro[ li`enza kemm-il darba ma tkunx sodisfatta li dak il-fond jkun konformi mal-]ti[iet stabbiliti b’dan l- Att jew ta]tu:

I\da li`enza tista’ ting]ata bil-kondizzjoni li jitwettqu dawk l-obbligi li jistg]u ji[u imposti fiha.
(2) Il-li`enza ta’ spi\erija g]andha tispe`ifika l-fond u l- attivitajiet li g]alihom tirreferi:
I\da l-Awtorità dwar il-Li`enzjar tista’, meta ssirilha applikazzjoni, tag]ti li`enza addizzjonali g]all-u\u ta’ xi fond identifikat li jkun se jintu\a b]ala ma]\en g]all-finijiet ta’ l-ispi\erija u wara li tkun sodisfatta li dak il- fond ikun konformi mal-]ti[iet stabbiliti b’dan l-Att jew ta]tu.

69. Meta l-Awtorità dwar il-Li`enzjar jidhrilha li jistg]u je\istu `irkostanzi li jirrendu me]tie[a l-konsiderazzjoni ta’ jekk g]andhiex ti[i mibdula, sospi\a jew revokata l-li`enza, l-Awtorità dwar il-Li`enzjar tista’ tinnotifika lid-detentur ta’ li`enza ta’ spi\erija

A 177
b’avvi\ biex, fi \mien li jista’ ji[i spe`ifikat fl-avvi\, jipprovdiha b’kull informazzjoni spe`ifikata fl-avvi\.

70. (1) Bla ]sara g]ad-disposizzjonijiet ta’ dan l-Att, kull li`enza mog]tija ta]t din it-Taqsima g]andha, kemm-il darba ma tkunx [iet qabel im[edda jew revokata, tiskadi fi tmiem il-validità tag]ha.

(2) Kull li`enza hekk mog]tija g]andha, kemm-il darba ma tkunx [iet revokata qabel, ti[[edded billi ssir applikazzjoni mid- detentur ta’ li`enza mill-anqas tliet xhur qabel l-iskadenza tal-perjodu ta’ validità.
(3) L-Awtorità dwar il-Li`enzjar tista’ b’regoli tistabbilixxi l- perjodu ta’ validità ta’ li`enza ma]ru[a ta]t din it-Taqsima.
(4) Meta ssir applikazzjoni lill-Awtorità dwar il-Li`enzjar g]at-ti[did ta’ li`enza ta]t din it-Taqsima, l-Awtorità dwar il- Li`enzjar:
(a) g]andha [[edded il-li`enza, kemm b’modifikazzjonijiet kemm ming]ajrhom, g]al dak il-perjodu ulterjuri li jista’ jkun spe`ifikat; jew
(b) jekk, wara li tqis id-disposizzjonijiet ta’ dan l-Att, tqis li jkun me]tie[ jew spedjenti li hekk isir, tista’ tirrifjuta li [[edded il-li`enza.
(5) Id-disposizzjonijiet ta’ l-artikoli 25 u 39 g]andhom jg]oddu g]al applikazzjonijiet b]al dawn.

71. }add ma jista’ jittrasferixxi li`enza kemm-il darba ma jkunx awtorizzat mill-Awtorità dwar il-Li`enzjar, liema awtorizzazzjoni ma ting]atax jekk l-Awtorità dwar il-Li`enzjar ma tkunx sodisfatta li d-detentur [did tal-li`enza jkun ]ares kull ]tie[a stabbilita b’dan l-Att jew ta]tu u sakemm ma jit]allas id-dritt preskritt.

72. L-Awtorità dwar il-Li`enzjar tista’ tissospendi li`enza ta’ spi\erija mog]tija ta]t dan l-Att g]al dak il-perjodu li tista’ tistabbilixxi jew tista’ tirrevoka, jew tibdel id-disposizzjonijiet ta’ xi tali li`enza f'kull wie]ed mill-ka\ijiet li [ejjin:

(a) meta xi ]a[a li ting]ad fl-applikazzjoni li l-li`enza tkun [iet ma]ru[a abba\i tag]ha tkun falza jew inkompleta;
(b) meta kien hemm bdil materjali ta' `irkostanzi dwar xi ]a[a minn dawk;

G]al kemm

\mien iddum u

ti[did ta’ li`enza ta’ spi\erija.

Trasferiment ta’ li`enza ta’ spi\erija.

Sospensjoni jew revoka ta’ li`enza ta’ spi\erija.

A 178
(`) meta jkunu inkisru d-disposizzjonijiet tal-li`enza mid-detentur ta’ li`enza; jew
(d) f'kull `irkostanza o]ra li tista’ ti[i stabbilita b’dan l- Att jew ta]tu:

G]eluq temporanju ta’ spi\erija.

Obbligi ta’ detentur ta’ li`enza ta’ spi\erija.

I\da meta tag]mel dan l-Awtorità tal-Li`enzjar g]andha tinnotifika lid-detentur ta’ li`enza bid-de`i\joni tag]ha u tag]ti r- ra[unijiet dettaljati li fuqhom tkun motivata dik id-de`i\joni.

73. (1) Id-detentur ta’ li`enza ta’ xi spi\erija ma g]andux jag]laq spi\erija, temporanjament jew xort’o]ra, kemm-il darba ma jkunx ta mill-anqas erbg]a w g]oxrin sieg]a avvi\ lil, u dak l-g]eluq ikun [ie hekk awtorizzat minn, l- Awtorità dwar il-Li`enzjar:

I\da dak l-g]eluq temporanju ma g]andux jinfitiehem b]ala li jinkludi l-g]eluq ta’ spi\erija kif jirri\ulta mill-assenza mhux prevista jew mistennija ta’ xi spi\jar, forza ma[[uri li tirri\ulta f’li l- fond ma jkunx jista’ jinfeta], jew l-g]eluq barra mill-]inijiet tan- negozju stabbiliti g]all-ispi\eriji b’regoli mag]mulin mill-Awtorità dwar il-Li`enzjar.
(2) Bla ]sara g]ad-disposizzjonijiet tas-subartikolu (1), il- li`enza ta’ spi\erija li tkun baqg]et mag]luqa g]al perjodu ta’ ]amest ijiem konsekuttivi ming]ajr l-awtorizzazzjoni ta’ l-Awtorità dwar il- Li`enzjar, g]andha titqies li tkun [iet awtomatikament revokata.
(3) L-Awtorità dwar il-Li`enzjar tista’, meta tir`ievi xi avvi\ kif hemm imsemmi fis-subartikolu (1), jew meta ssir taf li spi\erija tkun in\ammet mag]luqa, tissi[illa l-prodotti medi`inali kollha, kull fejn dawn ikunu qed jin\ammu mid-detentur ta’ li`enza skond id- disposizzjonijiet ta’ dan l-Att, u televa kull re[istru me]tie[ li jin\amm mid-detentur ta’ li`enza skond il-li[i jew xi li[i o]ra.

74. Detentur ta’ li`enza ta’ spi\erija g]andu -

(a) minnufih jinforma lill-Awtorità dwar il-Li`enzjar dwar kull tibdil ta' l- ispi\jar responsabbli qabel ma ssir dik il- bidla;
(b) jipprovdi lil uffi`jali awtorizzati b’a``ess g]all-fond tieg]u f’kull ]in ra[onevoli;
(`) jag]mel possibbli li l-Awtorità dwar il-Li`enzjar tkun tista’ taqdi dmirijietha kif stabbiliti b’dan l-Att jew ta]tu;
(d) j\omm dawk ir-records g]al kull operazzjoni li ssir fi prodotti medi`inali b]alma jista’ ji[i stabbilit b’dan l-Att jew
A 179
ta]tu u jara li dawk ir-records ikunu disponibbli g]all-ispezzjon minn kull uffi`jal awtorizzat g]al dak il-perjodu ta’ \mien skond ma jkun jen]tie[ b’dan l-Att jew ta]tu;
(e) j]ares kull regolament jew Ordnijiet li jkunu jirrigwardaw kull prattika stabbilita fil-bejg] bl-imnut ta’ prodotti medi`inali li tista’ ti[i stabbilita minn jew ta]t dan l- Att;
(f) jiddisponi minn prodotti medi`inali kif stabbilit minn jew ta]t dan l-Att jew ta]t xi li[i o]ra;
(g) responsabbilitajiet o]ra li jistg]u ji[u stabbiliti minn
\mien g]al \mien minn jew ta]t dan l-Att.

75. (1) Kull spi\erija g]andha tkun mani[[ata minn spi\jar hawn i\jed’il quddiem imsejja] ''spi\jar responsabbli''.

(2) L-ispi\jar responsabbli g]andu:
(a) ja[ixxi b]ala l-ispi\jar responsabbli ta’ spi\erija li jkollha li`enza inklu\ kull fond ie]or u\at b]ala ma]\en mill- imsemmija spi\erija skond l-artikolu 68(2);
(b) ji\gura li jew hu jew spi\jar ie]or ibig] jew jissorvelja l-bejg] ta’ prodotti medi`inali fl-ispi\erija u j\omm records ta’ l-ispi\jar li kien pre\enti fl-ispi\erija matul il-]in li din damet miftu]a;
(`) j\omm kull dokument, informazzjoni jew prova bil- mod skond ma jkun me]tie[ li jin\amm b’dan l-Att jew ta]tu;
(d) jaqdi daw l-obbligi relatati ma’ spi\jar responsabbli skond ma jistg]u ji[u stabbiliti b’dan l-Att jew ta]tu;
(e) jinnomina spi\jar responsabbli sostitut meta ma jkunx jista’ jwettaq dmirijietu g]al perjodu ta’ ]amest ijiem jew aktar konsekuttivi u jav\a lill-Awtorità dwar il-Li`enzjar b’tali sostituzzjoni:
I\da f’ka\ijiet e``ezjonali d-detentur ta’ li`enza jista' jinnomina sostitut u jav\a b’dan lill-Awtorità dwar il- Li`enzjar;
(f) j]ares kull regolament jew regola li tkun tirrigwarda kull prattika kif imiss fid-dispensa ta’ prodotti medi`inali li tista’ ti[i stabbilita’ minn jew ta]t dan l-Att;

Spi\jar responsabbli.

A 180
(g) jiddisponi minn prodotti medi`inali kif stabbilit b’dan l-Att jew ta]tu jew b’xi li[i o]ra.
(3) Ebda spi\jar ma jista’, ming]ajr l-awtorità bil-miktub ta’ l- Awtorità dwar il-Li`enzjar, jag]milha ta’ spi\jar responsabbli ta’
\ew[ spi\eriji jew aktar:
I\da l-Awtorità dwar il-Li`enzjar ma g]andhiex tag]ti dik l- awtorità kemm-il darba ma tkunx sodisfatta li dak l-ispi\jar jkun jista’ ra[onevolment iwettaq id-dmirijiet ta’ spi\jar responsabbli g]al aktar minn spi\erija wa]da.

Dmirijiet ta’

spi\jar.

Interess fi spi\erija.

Detentur ta’ li`enza jista’ jimpjega spi\jar wie]ed jew

aktar .

Prodotti medi`inali li g]andhom jinbieg]u minn spi\erija.

(4) Ebda spi\jar ma g]andu jibda jaqdi jew jabbanduna dmirijietu b]ala spi\jar responsabbli ta’ spi\erija ming]ajr ma qabel jag]ti avvi\ bil-miktub g]aldaqstant lill-Awtorità dwar il-Li`enzjar.

76. (1) Kemm-il darba ma ji[ix xort’o]ra provdut b’dan l- Att jew ta]tu, prodott medi`inali g]andu ji[i biss ippreparat jew mibjug] minn spi\erija minn spi\jar:

I\da spi\jar jista’ jippermetti li prodotti medi`inali ji[u ppreparati jew mibjug]in minn pharmacy technician ta]t is- supervi\joni personali tieg]u skond ma hemm regolat minn jew ta]t dan l-Att.
(2) Fit-twettiq tal-funzjonijiet tieg]u fil-preparazzjoni, dispensa u t-tqassim ta’ prodotti medi`inali minn spizerija, spi\jar g]andu jagixxi skond tali standards li jistg]u ji[u stabbiliti minn jew ta]t dan l-Att jew ta]t xi li[i o]ra.

77. Il-kondizzjonijiet u kriterji li jistabbilixxu jekk persuna g]andha jew m’g]andhiex interess dirett jew indirett fi spi\erija g]andhom ji[u stabbiliti fit-Tielet Skeda ta’ dan l-Att.

78. Id-detentur ta’ li`enza g]andu jimpjega spi\jar sabiex jaqdi r-responsabbiltajiet ta’ spi\jar responsabbli u g]andu jipprovdilu l-appo[[ tieg]u kollu u b’ebda mod ma g]andu jinda]al fir-responsabbiltajiet ta’ l-ispi\jar jew fir-responsabbiltajiet professjonali ta’ spi\jar fit-twettiq ta’ dmirijietu kif imfissra b’dan l- Att jew ta]tu jew ta]t xi o]ra li[i.

79. (1) Fi spi\erija g]andu jsir biss dispensa ta’ prodotti medi`inali u kummer` ta’ prodotti jew gruppi jew klassijiet ta’ prodotti li jistg]u minn \mien g]al \mien ji[u preskritti b’regoli ma]ru[a mill-Awtorità dwar il-Li`enzjar.

(2) Kemm-il darba ma ji[ix xort’o]ra provdut b’dan l-Att jew ta]tu, prodott medi`inali g]andu biss jinbieg] minn spi\erija:
A 181
I\da l-Awtorità dwar il-Li`enzjar tista’ f’`irkostanzi spe`jali relatati mal-g]oti ta’ servizzi lill-pubbliku, b’regoli tippreskrivi li prodott medi`inali jew klassi jew klassijiet ta’ prodotti medi`inali li ji[u hemm spe`ifikati jistg]u jinbieg]u minn xi fond li ma jkunx spi\erija liema fond ma jistax ikun fond minn fejn o[[etti jinbieg]u bl-imnut:
I\da wkoll, l-Awtorità dwar il-Li`enzjar tista’ fl-istess
`irkostanzi b’regoli tippreskrivi li prodott medi`inali jew klassi jew klassijiet ta’ prodotti medi`inali li ji[u hemm spe`ifikati jistg]u jinbieg]u, ji[u preparati jew provduti lil pazjent minn xi persuna, li ma tkunx spi\jar li jkollha kwalifika kif imiss g]al dan il-g]an:
I\da wkoll, dawk ir-regoli g]andhom jipprovdu dwar i`-
`irkostanzi li ta]thom jistg]u jsiru l-bejg], il-preparazzjoni jew it- tqassim filwaqt li tqieg]ed dawk ir-restrizzjonijiet li jistg]u ji[u provduti.
(3) L-Awtorità dwar il-Li`enzjar tista’ b’regoli tistabbilixxi lista ta’ prodotti medi`inali li mill-anqas g]andhom ikunu disponibbli fi spi\erija f’kull waqt:
I\da din il-]tie[a tista’ tkun temporanjament imwarrba g]ar-rigward ta’ xi prodott medi`inali jew klassi ta’ prodott medi`inali partikolari f’`irkostanzi e``ezjonali, jekk l-Awtorità dwar il-Li`enzjar tkun sodisfatta li n-nuqqas ta’ disponibbiltà ta’ dak il- prodott medi`inali jew klassi ta’ prodott medi`inali minn spi\erija ma jkunx jaqa’ ta]t il-kontroll ta’ l-ispi\jar responsabbli.

80. (1) Spi\jar g]andu jipprepara jew ibig] prodott medi`inali me]tie[ minn persuna li tippre\enta ri`etta kemm-il darba huwa ma jkollux ra[uni [ustifikata jissuspetta li r-ri`etta tkun falza, li l-persuna tkun qed tag]mel u\u ]a\in mill-prodott medi`inali ordnat, jew li l-prodott medi`inali ma jkunx disponibbli jew jekk ikollu ra[unijiet professjonali g]aliex ma g]andux jipprepara jew ibig] skond ma jkollu fir-ri`etta.

(2) Meta ti[i ppre\entata lil spi\jar ri`etta g]al prodott medi`inali, kemm-il darba min jo]ro[ ir-ri`etta ma jindikax prodott ta’ ditta partikolari billi jikteb ''tad-ditta'' jew ''®" fuq ir-ri`etta, huwa jista’ jbieg] kemm il-prodott medi`inali ordnat kemm prodott medi`inali ekwivalenti li jkollu l-istess entità, do\a, forma ta' do\a[[, formulazzjoni u frekwenza ta’ do\a[[ kimi`i b]alma jkollu l-prodott medi`inali indikat fuq ir-ri`etta.
(3) Meta, fil-bejg] ta’ xi prodott medi`inali, spi\jar jiskopri li jkun hemm ra[unijiet il-g]aliex il-prodott medi`inali ma g]andux

Bejg] ta’ prodott medi`inali.

A 182
jinbieg] lill-pazjent jew li l-amministrazzjoni tad-do\a[[ indikata fil-
]ru[ ta’ ri`etta jkun joltrepassa dik li tista’ titqies b]ala do\a terapewtiku sigura, l-ispi\jar g]andu d-dmir jinforma b’dan lil min ikun qed jo]ro[ ir-ri`etta u jista’ jitlob lil dik il-persuna tiktiblu bil- inka jew b’xi mod ie]or li ma jit]assarx fuq ir-ri`etta dikjarazzjoni fejn jassumi r-responsabbiltà g]al dik ir-ri`etta.
(4) L-ispi\jar g]andu jassumi kull responsabbiltà g]all-bejg] ta’ prodotti medi`inali li ma jkunux je]tie[u ri`etta biex jinbieg]u lill-pazjenti.

Bejg] b’ri`etta. 81. (1) Ebda spi\jar ma jista’ jbig] prodott medi`inali ]lief bir-ri`etta ta’ tabib, dentist jew kirurgu veterinarju jew persuna o]ra awtorizzata li to]ro[ ri`etta ta]t dan l-Att jew xi Att ie]or, kemm-il darba l-prodott medi`inali ma jitqiesx mill-Awtorità dwar il- Li`enzjar li ma je]tie[x ri`etta medi`inali.

Meta ti[i ppre\entata ri`etta.

Ittikkettjar ta’ prodotti mibjug]a.

Bejg] ta’ prodotti skaduti, mg]arrqa jew mhux perfetti.

(2) Id-disposizzjonijiet tas-subartikolu (1) g]andhom ukoll jg]oddu g]al prodotti jew sustanzi li mhux klassifikati b]ala prodotti medi`inali imma li jitqiesu b]ala li je]tie[u ri`etta medi`inali g]all- u\u tag]hom mill-awtorità kompetenti rilevanti.

82. L-Awtorità dwar il-Li`enzjar tista’ b’regoli tippreskrivi l- format, il-kontenut u kif ti[i ppre\entata ri`etta li tkun me]tie[a b’dan l-Att jew ta]tu.

83. L-ispi\jar g]andu jwa]]al tikketta fuq kull prodott medi`inali jew formola ma[istrali li jinbieg]u skond dawk ir- regolamenti jew regoli mag]mula ta]t dan l-Att.

84. Ebda spi\jar responsabbli ma g]andu jbig], jippermetti l- bejg], it-tqassim jew il-forniment xort’o]ra ta’ xi -

(a) sustanza mhux perfetta, mg]arrqa jew dannu\a;
(b) prodott medi`inali li jkollu data ta’ u\u li tkun skaduta;
(`) ikel mhux skond id-disposizzjonijiet ta’ l-Att ta' l-
2002 dwar is-Sigurezza ta’ l-Ikel jew regolamenti mag]mulin ta]tu:
I\da dawk is-sustanzi jew prodotti medi`inali mhux perfetti, mg]arrqa jew skaduti g]andhom biss ji[u mi\muma f’dak il- post u b’dak il-mod skond ma l-Awtorità dwar il-Li`enzjar tista’ minn
\mien g]al \mien b’regoli tistabbilixxi.
A 183

85. (1) Ebda spi\jar responsabbli ma jista’ j\omm x’imkien fl-ispi\erija prodott medi`inali f’kontenitur jew ta]t dawk il- kondizzjonijiet li ma jkunux adatti g]ax-xorta tieg]u u li ma jkunux tali li j]arsuh ninn kull alterazzjoni, deterjorazzjoni jew kontaminazzjoni.

(2) Ebda spi\jar responsabbli ma jista’ jippermetti li prodott medi`inali jin\amm ta]t ir-responsabbiltà tieg]u jew li jin]a\en barra mill-ispi\erija ta]t it-tmexxija tieg]u, u jkun id-dmir tieg]u li ji\gura li l-ispi\erija jkollha l-fa`ilitajiet li ti\gura li l-prodotti medi`inali jin]a\nu skond rakkomandazzjonijiet ta’ ]\in:
I\da fil-ka\ meta l-Awtorità dwar il-Li`enzjar tkun ]ar[et li`enza biex jin\ammu jew jin]a\nu prodotti medi`inali f’xi fond li ma jkunx spi\erija, r-responsabbiltajiet ta’ l-ispi\jar responsabbli g]andhom ikunu wkoll japplikaw g]al dak il-fond.
86. Il-fond, il-fa`ilitajiet, ir-records u t-tag]mir u\at g]all-
]\in, preparazzjoni u bejg] ta’ prodotti medi`inali g]andhom jin\ammu skond il-]ti[iet u standards stabbiliti b’dan l-Att jew ta]tu.
87. Il-preparazzjoni ta’ formoli ma[istrali u uffi`jali, u l- ippakkettjar minn qabel, rikostituzzjoni, bejg] u amministrazzjoni ta’ prodotti medi`inali u kull attività o]ra li g]andha x’taqsam ma’ prodotti medi`inali u l-u\u tag]hom, g]andhom ikunu skond tali standards li jistg]u ji[u stabbiliti ta]t dan l-Att.

88. (1) L-Awtorità dwar il-Li`enzjar g]andu jkollha l-jedd tispezzjona kull spi\erija u fond li jkollhom li`enza biex jintu\aw b]ala m]a\en ta]t l-artikolu 68(2) kull meta tqis li jkun hekk me]tie[.

(2) Kull spezzjoni b]al dik hawn qabel imsemmija g]andha ssir fil-pre\enza ta’ l-ispi\jar responsabbli jew ta’ l-ispi\jar li g]al dak i\-\mien ikun qed jie]u ]sieb l-ispi\erija.
(3) Fil-waqt ta’ l-ispezzjoni, l-uffi`jal li jispezzjona g]andu jag]mel lista ta’ defi`jenzi li jistg]u ikunu [ew identifikati fil-waqt ta’ l-ispezzjoni u g]andu jiffirma dik il-lista, u dik il-lista g]andha ti[i kontrosenjata mill-ispi\jar responsabbli jew mill-ispi\jar li f’dak i\-\mien ikun qed jie]u ]sieb l-ispi\erija:
I\da l-uffi`jal li jispezzjona g]andu jag]mel rapport ta’ l- ispezzjoni fi \mien sebat ijiem tax-xog]ol minn dik l-ispezzjoni u g]andu jibg]at kopja ta’ dak ir-rapport lill-Awtorità dwar il- Li`enzjar, lid-detentur ta’ li`enza u lill-ispi\jar responsabbli:
I\da wkoll l-ispi\jar responsabbli jew l-ispi\jar li f’dak i\-
\mien ikun qed jie]u ]sieb l-ispi\erija, jista’ jag]mel il-kummenti

}\in ta’ prodotti medi`inali fi spi\erija.

Il-fond, e``., skond il-]ti[iet u standards.

L-ispi\jar g]andu jimxi skond standards stabbiliti.

Spezzjoni ta’

spi\eriji.

A 184
tieg]u jew xort’o]ra jag]mel riservi dwar il-kontenut tal-lista msemmija.
(4) (a) Jekk filwaqt li tkun qed issir l-ispezzjoni, tinstab xi
]a[a bi ksur tad-disposizzjonijiet ta’ dan l-Att jew ta’ regolamenti mag]mulin ta]tu, l-uffi`jal li jispezzjona g]andu minnufih jeleva dak l-o[[ett.
(b) Il-folja tat-tisrir jew il-kontenitur li jkun fih l-o[[ett elevat g]andhom ji[u ssi[illat u l-uffi`jal li jispezzjona u l-ispi\jar responsabbli g]andom jiffirmaw fuq is-si[ill:
I\da jekk l-ispi\jar responsabbli hekk jitlob, l-o[[ett inkwistjoni g]andu ji[i maqsum, mill-uffi`jal li jispezzjona, f’\ew[ partijiet indaqs, li ji[u ssi[illati u ffirmati bil-mod kif hawn qabel imsemmi, u parti wa]da minnhom ting]ata lill-ispi\jar rsponsabbli:
I\da wkoll l-uffi`jal li jispezzjona g]andu jibg]at l-o[[ett elevat, iffirmat u ssi[[illat bil-mod imsemmi qabel, lill-Awtorità dwar il-Li`enzjar flimkien mar-rapport dwar l-ispezzjoni deskritt fis- subartikolu (3).

Ftu] ta’

spi\eriji.

Tifsira ta’

veleni.

(5) Jekk l-ispi\jar responsabbli jew l-ispi\jar li f’dak i\-\mien ikun qed jie]u ]sieb l-ispi\erija jirrifjuta milli jikkontrosenja l-lista imsemmija fis-subartikolu (3), l-uffi`jal li jispezzjona g]andu jirre[istra dak il-fatt fuq il-lista msemmija flimkien mar-ra[unijiet mog]tija, jekk ikun hemm, g]al dak ir-rifjut.

89. L-Awtorità dwar il-Li`enzjar tista’ b’avvi\ fil-Gazzetta tistabbilixxi l-]inijiet tan-negozju ta’ spi\eriji u tista’ wkoll te]tie[ li spi\eriji f’lokalitajiet jew distretti spe`ifikati jinfet]u g]all-qadi ta’ parru``ani f’dawk il-[ranet u f’dawk il-]inijiet li jistg]u ji[u spe`ifikati f’dak l- avvi\.

TAQSIMA IV

SUSTANZI VELENU|I

90. G]all-finijiet tad-disposizzjonijiet li jinsabu f’din it- Taqsima, ''velenu'' tfisser -

(a) dawk is-sustanzi kollha li, wkoll jekk jittie]du f’do\a \g]ira ]afna, jistg]u jikka[unaw il-mewt jew feriment gravi fis-sa]]a ta' bniedem,
(b) dawk is-sustanzi kollha li l-Ministru jista', bil-parir ta' l-Awtorità dwar il-Li`enzjar, minn \mien g]al \mien jippreskrivi,
A 185
i\da ma tinkludi ebda sustanza simili li tintu\a, jew li tkun inti\a li tintu\a, g]al finijiet domesti`i ta’ kuljum, liema msemmija sustanza, madankollu, g]andha titqies b]ala velenu g]all-fini ta’ l-artikolu 94.

91. }add ma jista’ j\omm g]all-bejg], jimmanifattura, jbieg] jew xort’o]ra jiddistribwixxi jew imexxi veleni ming]ajr ma jkollu li`enza ma]ru[a mill-Awtorità dwar il-Li`enzjar.

92. (1) Il-li`enza msemmija fl-artikolu 91 g]andha ting]ata biss lil persuni li jimmanifatturaw u jmexxu prodotti kimi`i, koloristi u dawk il-persuni l-o]ra li jkunu je]tie[u jag]mlu u\u mill-veleni fi- e\er`izzju tal-kummer` jew il-professjoni tag]hom.

(2) Dik il-li`enza g]andha tkun turi l-isem u l-kunjom tad- detentur ta’ li`enza, s-seng]a jew il-professjoni tieg]u, u l-post fejn ikun bi ]siebu ji[[estixxi in-negozju jew il-professjoni tieg]u u kull informazzjoni o]ra li tista’ ti[i minn \mien g]al \mien stabbilita b’regoli mag]mula mill-Awtorità dwar il-Li`enzjar.

93. Kull persuna mog]tija li`enza ta]t l-artikolu 91 g]andha

\\omm is-sustanzi velenu\i kollha f’post imwarrab u sigur, li `-
`avetta tieg]u g]andha dejjem tin\amm mid-detentur tal-li`enza.

94. (1) Ebda persuna mog]tija li`enza ta]t l-artikolu 91 ma g]andha tbieg] jew tikkunsinna xi sustanza velenu\a, kemm bl- ingrossa kemm bl-imnut, lil persuna li ma tkunx spi\jar, kemm-il darba ma tin[iebx ri`etta jew g]al g]anijiet ta’ disinfettar jew ta’ industrja jew g]al kull skop ie]or li jista’ ji[i awtorizzat mill- Awtorità dwar il-Li`enzjar.

(2) Kull persuna mog]tija li`enza ta]t l-artikolu 91 g]andu jkollha, \\omm, ta[[orna, ta]\en u tag]mel disponibbli lill-Awtorità dwar il-Li`enzjar jew lil kull persuna awtorizzata dik l-informazzjoni li tista’ minn \mien g]al \mien tkun me]tie[a mill-Awtorità dwar il- Li`enzjar u b’dak il-mod li jista’ minn \mien g]al \mien jen]tie[ mill-Awtorità dwar il-Li`enzjar.
(3) Is-sustanzi velenu\i g]andu jkollhom dawk it-tikketti li l- Awtorità dwar il-Li`enzjar tista’ minn \mien g]al \mien tistabbilixxi b'regoli.

95. L-Awtorità dwar il-Li`enzjar jew kull uffi`jal awtorizzat tista’, fl-interess tas-sa]]a pubblika, tag]mel vi\ti mhux av\ati [o xi fond kummer`jali ta’ persuni li jimmanifatturaw u jmexxu prodotti kimi`i u ta’ persuni o]ra msemmija fl-artikolu 91.

96. Ming]ajr pre[udizzju g]ad-disposizzjonijiet ta’ l-Att ta’ l-

2002 dwar il-Kontroll tal-Pesti`idi, hu projbit \-\rig], it-tfig], it-

Ti\mim e``., ta’

veleni.

Li`enza g]all- bejg] ta’ veleni.

Ti\mim ta’ sustanzi velenu\i f’post sigur.

Bejg] ta’ sustanzi velenu\i.

Setg]a ta’

spezzjon.

Qmu], \rierag] e``., ivvelenati. Kap. 430.

A 186
tqeg]id jew it-t]awwil, jew li [[ieg]el li jsir i\-\rig], it-tfig], it- tqeg]id jew it-t]awwil fi jew fuq xi art jew xi post ie]or fil-bera] ta' xi ]abba, \errieg]a, tmig] jew sustanza li tkun [iet hekk miblula jew mxarrba fil-velenu, jew li tkun hekk t]alltet ma’ xi velenu jew ingredjent jew preparazzjoni o]ra b’mod li ssir velenu\a u jkollha l- iskop li teqred il-]ajja.

TAQSIMA V

Restrizzjonijiet spe`jali fuq persuni li ji[u fornuti bi prodotti medi`inali.

Adulterazzjoni ta’ prodotti medi`inali.

MOD IE}OR KIF JI{U TTRATTATI PRODOTTI MEDICINALI

97. L-Awtorità dwar il-Li`enzjar tista’ b’regoli tipprovdi, kemm dwar prodotti medi`inali b’mod [enerali kemm dwar prodotti medi`inali ta’ xi deskrizzjoni jew li jaqg]u f’xi klassi spe`ifikata fir- regoli li, bla ]sara g]al dawk l-e``ezzjonijiet li jistg]u ji[u hekk spe`ifikati, ]add -

(a) g]ax ikun id-detentur ta’ xi awtorizzazzjoni ta’
tqeg]id fis-suq, jew
(b) fi-kors ta’ kummer` [estit minnu u li jikkonsisti, g]alkollox jew f’parti, fil-manifattura ta’ prodotti medi`inali jew fil-bejg] ta’ prodotti medi`inali b’negozju bl-ingrossa,
ma g]andu jbieg] jew iforni xi prodott medi`inali li dwaru japplikaw ir-regoli lil xi persuna li ma tinkwadrax fi klassi spe`ifikata f'dawk ir- regoli.

98. }add ma g]andu-

(a) j\id xi sustanza ma', jew jag]mel astrazzjoni ta’ xi sustanza minn, prodott medi`inali b’mod li jolqot b’mod dannu\ il-kompo\izzjoni tal-prodott, bil-]sieb li l-prodott jinbieg] jew ji[i fornut f’dak l-istat; jew
(b) ibieg] jew iforni, jew joffri jew jesponi g]all-bejg] jew forniment, jew ikollu fil-pussess tieg]u g]all-fini ta’ bejg] jew forniment, xi prodott medi`inali li l-kompo\izzjoni tieg]u tkun [iet milquta b’mod dannu\ bi\-\jieda jew l-astrazzjoni ta’ xi sustanza.

TAQSIMA VI

REATI U PIENI

Reati u pieni. 99. (1) Ming]ajr pre[udizzju g]al kull responsabbiltà o]ra ta]t xi li[i o]ra, kull persuna li tonqos milli tosserva xi disposizzjoni ta’ dan l-Att jew xi regolamenti jew regoli mag]mulin ta]tu tkun

A 187
]atja ta’ reat u tista’, meta tinsab ]atja, te]el, fil-ka\ ta’ reat kontra:
(a) id-disposizzjonijiet ta’ l-artikoli 20, 24, 28, 37, 39,
41 u 43, multa ta’ mhux anqas minn g]axart elef lira u mhux i\jed minn ]amsin elf lira jew pri[unerija g]al \mien mhux i\jed minn sentejn, jew dik il-multa u pri[unerija flimkien;
(b) id-disposizzjonijiet ta’ l-artikoli 54, 56, 58 u 61, multa ta’ mhux inqas minn ]amest elef lira u mhux i\jed minn tletin elf lira jew pri[unerija g]al \mien mhux i\jed minn sitt xhur, jew dik il-multa u pri[unerija flimkien;
(`) id-disposizzjonijiet ta’ l-artikoli 44, 45, 66(1), 71,
75(3), 75(4), 76(1), 81(1), 91 u 98, multa ta’ mhux inqas minn elfejn lira u mhux i\jed minn g]oxrin elf lira, jew pri[unerija g]al \mien mhux i\jed minn tliet xhur, jew dik il-multa u pri[unerija flimkien;
(d) id-disposizzjonijiet ta’ l-artikoli 59, 60, 65, 74(b),
75(1), 75(2), 84, 93, 94(1) u 96, multa ta’ mhux inqas minn
]ames mitt lira u mhux i\jed minn g]axart elef lira;
(e) d-disposizzjonijiet ta’ l-artikoli 31, 66(2), 78, 85(1),
85(2) u 94(2), multa ta’ mhux inqas minn mitejn lira u mhux i\jed minn ]amest elef lira;
(f) id-disposizzjonijiet ta’ l-artikoli 29, 73(1) u 94(3), multa ta’ mhux inqas minn mitt lira u mhux i\jed minn elf lira.
(2) Ming]ajr pre[udizzju g]as-setg]at ta' l-Awtorità dwar il- Li`enzjar ta]t dan l-Att, meta persuna li tkun g]amlet reat tkun id- detentur ta’ li`enza jew ta’ awtorizzazzjoni ta]t dan l-Att, u dak is- sejbien ta’ ]tija jkun it-tielet sejbien ta’ ]tija jew wie]ed sussegwenti, il-qorti g]andha, fuq talba tal-prosekuzzjoni, tordna r-revoka jew is- sospensjoni tal-li`enza jew awtorizzazzjoni hawn qabel imsemmija.

100. (1) Minkejja kull li[i o]ra li tipprovdi g]al provvedimenti dwar reati, meta l-Awtorità dwar il-Li`enzjar tkun tal- fehma li persuna tkun ikkommettiet reat kontra dan l-Att jew xi regolamenti jew regoli mag]mulin ta]tu, l-Awtorità g]andha tag]ti avvi\ bil-miktub lil dik il-persuna fejn tiddeskrivi r-reat li dwaru dik il-persuna tkun qed ti[i akku\ata, fejn ji[u indikati l-passi li g]andhom jittie]du sabiex jirrimedjaw ir-reat u l-penali li g]andha tit]allas g]al dak ir-reat.

(2) Il-Ministru g]andu jippreskrivi l-penalitajiet li jistg]u jintalbu mill-Awtorità dwar il-Li`enzjar dwar xi reat spe`ifikat:

Pro`edura spe`jali.

A 188
I\da penali b]al dik ma g]andhiex tkun te``edi ammont ta’
g]axart elef lira.

Kap. 9.

(3) Meta jkun ing]ata avvi\ ta]t dan l-artikolu, il-persuna msemmija fl-avvi\ tista’, fi \mien wie]ed u g]oxrin jum minn meta ti[i notifikata bl-avvi\, ta``etta r-responsabbiltà g]ar-reat spe`ifikat fl-avvi\ u fi \mien l-istess perjodu t]allas il-penali indikata fl-avvi\, u tikkonforma ru]ha ma’ kull disposizzjoni relattiva ta’ dan l-Att, jew tar-regolamenti jew regoli mag]mulin ta]tu u ma jkunu jistg]u jittie]du ebda pro`edimenti ulterjuri ta]t dan l-Att dwar dak ir-reat.
(4) Meta l-persuna li jing]atalha l-avvi\ ta]t is-subartikolu (1) ma t]allasx il-penali fi \mien il-perjodu ta' wie]ed u g]oxrin [urnata msemmi fis-subartikolu (3) u ma osservatx, fi\-\mien spe`ifikat, il-
]ti[iet ta' dan l-Att, jistg]u jittie]du pro`edimenti ordinarji kontriha
skond id-disposizzjonijiet tal-Kodi`i Kriminali, ta’ dan l-Att u ta’ kull li[i o]ra li tkun tapplika dwar ir-reat.

TAQSIMA VII

INFURZAR

Dritt ta’ d]ul. 101. (1) Bla ]sara g]ad-disposizzjonijiet ta’ dan l-artikolu, u ming]ajr pre[udizzju g]ad-disposizzjonijiet l-o]ra ta’ dan l-Att, persuna li tkun awtorizzata bil-miktub kif imiss mill-Awtorità dwar il-Li`enzjar g]andu jkollha dritt, meta turi l-awtorizzazzjoni jew il- kredenzjali tag]ha, f’kull ]in ra[onevoli tid]ol f’xi fond:

(a) bil-g]an li ta``erta ru]ha jekk ikunx hemm jew kienx hemm, jew x’aktarx li jkun hemm xi ksur ta’ xi disposizzjoni ta’ dan l-Att jew ta’ xi regolamenti jew regoli mag]mulin ta]tu;
(b) [eneralment g]all-finijiet ta’ l-e\er`izzju mill- Awtorità dwar il-Li`enzjar tal-funzjonijiet tag]ha ta]t dan l-Att jew ta]t regolamenti jew regoli mag]mulin ta]tu.
G]all-fini ta’ din it-Taqsima, fond jiftiehem b]ala li jinkludi bini, struttura, xi post ie]or li jkun jew kwalunkwe mezz ta’ trasport.
(2) Uffi`jal awtorizzat ikollu d-dritt, meta juri l- awtorizzazzjoni tieg]u, f’kull ]in ra[onevoli jitla’ abbord kull bastiment jew in[enju ta’ l-ajru g]all-fini li ja``erta ru]u jekk ikunx hemm f’xi bastiment jew in[enju ta’ l-ajru xi sustanza jew o[[ett importat bi ksur ta’ xi disposizzjoni ta’ dan l-Att jew ta’ xi regolamenti jew regoli mag]mulin ta]tu jew jekk l-imsemmi in[enju jkunx qed iwettaq xi attività bi ksur ta’ xi wa]da mill-imsemmija
A 189
disposizzjonijiet.

102. (1) Bil-g]an li ji[i a``ertat jekk ikunx hemm jew kienx hemm jew x’aktarx ikun hemm ksur ta’ dan l-Att jew ta’ regolamenti jew regoli mag]mulin ta]tu, uffi`jal awtorizzat ikollu d-dritt jispezzjona:

(a) kull sustanza jew o[[etti li jidhrulu li jkunu prodott medi`inali;
(b) kull o[[ett li jintu\a jew ikun ma]sub li jintu\a biex jitqieg]ed fih xi prodott medi`inali jew b]ala tikketta jew leaflet li jintu\a jew ikun ma]sub li jintu\a f’dak li g]andu x’jaqsam ma’ xi prodott medi`inali; jew
(`) kull impjant jew tag]mir li jidhrulu li jintu\aw jew ikunu ma]suba li jintu\aw f’dak li g]andu x’jaqsam mal- manifattura jew l-assembla[[ ta’ prodotti medi`inali, u kull pro`ess ta’ manifattura jew assembla[[ ta’ prodotti medi`inali u l-mezzi li jintu\aw g]aldaqshekk, f’kull stadju tal-pro`ess ta’ manifattura jew assembla[[, g]al ittestjar ta’ kull materjal wara li jkunu g]addew minn dawk il-pro`essi.
(2) Uffi`jal awtorizzat jista’, g]al kull fini spe`ifikata fis- subartikolu pre`edenti, jie]u kampjun:
(a) ta’ sustanzi jew prodotti medi`inali mibjug]in jew fornuti jew ma]suba biex jinbieg]u jew ji[u fornuti; jew
(b) ta’ sustanzi jew o[[etti u\ati jew ma]suba biex jintu\aw fil-manifattura ta’ xi prodott medi`inali.
(3) G]all-finijiet tas-subartikolu (1) ta’ dan l-artikolu, persuna awtorizzata jkollha l-jedd:
(a) li tispezzjona kull g]amla ta’ record, f’liema stat ikun, li jkollhom x’jaqsmu mal-manifattura, l-assembla[[, il- bejg] jew il-forniment ta’ xi prodott medi`inali u, meta tali records ikunu mi\muma f’g]amla elettronika:
(i) jista’ jkollha a``ess g]al, u tispezzjona u tivverifika l-operazzjoni ta’ xi computer, xi apparat asso`jat jew materjal li jkun jew li kien qed jintu\a f’dak li g]andu x’jaqsam mar-records; u
(ii) tista’ titlob lil kull persuna li tkun responsabbli minn, jew li xort’o]ra jkollha x’taqsam mat- t]addim tal-computer, apparat jew materjal, li tag]tih kull

Setg]a li tispezzjona, tie]u kampjuni u taqbad merkanzija u dokumenti.

A 190
tali assistenza li hija tista’ ra[onevolment titlob;
(b) li tag]mel kopji ta’ kull d]ul fi ktieb jew dokument mi[juba konformement mal-paragrafu pre`edenti u meta r- records ikunu mi\muma elettronikament, permezz ta’ computer jew xort’o]ra, te]tie[ li r-records jin[iebu f’g]amla intelli[ibbli li tista’ ti[i trasportata.
(4) Uffi`jal awtorizzat ikollu d-dritt jeleva, jwarrab u j\omm g]andu kull sustanza jew o[[ett li jkollu tassew g]aliex ja]seb li jkunu sustanzi jew o[[etti li dwarhom, jew permezz tag]hom, ikun qed isir jew kien qed isir reat ta]t dan l-Att, u kull dokument li dwaru jkollu tassew g]aliex ja]seb li jkun dokument li jista’ jen]tie[ li jin[ieb bi prova fi pro`edimenti ta]t dan l-Att.
(5) Bil-g]an li je\er`ita l-jedd mog]ti lilu ta]t subartikolu (4), kull persuna awtorizzata tista’, sakemm ikun ra[onevolment me]tie[ biex ikun hemm konformità mad-disposizzjonijiet ta’ dan l-Att u ta’ regolamenti jew regoli mag]mulin ta]tu, te]tie[ lil xi persuna tifta] billi tikser xi kontenitur, pakkett jew makna, jew li t]alliha tag]mel dan:
I\da meta persuna televa xi sustanza jew o[[ett, inklu\ xi dokument, g]all-finijiet spe`ifikati fis-subartikolu (4), hija g]andha tinforma lill-persuna ming]and min dawn ikunu [ew elevati u tag]tiha ri`evuta dwarhom.
(6) Ming]ajr pre[udizzju g]ad-disposizzjonijiet pre`edenti ta’ dan l-artikolu, persuna awtorizzata g]andu jkollha l-istess drittijiet b]al dawk mog]tija b’dawk id-disposizzjonijiet g]ar-rigward ta’ o[[etti li jappartjenu lil, jew xi kummer` [estit minn, applikant g]al awtorizzazzjoni jew `ertifikat ta]t it-Taqsima III ta’ dan l-Att, u tista’ te\er`ita dawk id-drittijiet g]all-fini li tivverifika kull dikjarazzjoni jew informazzjoni li jkun hemm fl-applikazzjoni g]all- awtorizzazzjoni jew i`-`ertifikat; u, meta bis-sa]]a tad- disposizzjonijiet ta’ dan is-subartikolu persuna te\er`ita xi dritt b]al dak spe`ifikat fis-subartikolu (4), dan g]andu jkun bla ]sara g]ad- dmir impost bis-subartikolu (5).
(7) Minkejja kull ]a[a li tinsab fid-disposizzjonijiet pre`edenti ta’ dan l-artikolu, meta persuna li tippretendi li tkun qed te\er`ita xi dritt bis-sa]]a tal-disposizzjonijiet ta’ dan l-artikolu ten]tie[ i[[ib xi awtorizzazzjoni jew kredenzjali li jkollha, dak il-jedd jista’ biss ji[i e\er`itat minnha wara li turi dik l-awtorizzazzjoni jew dawk il- kredenzjali li jkollha.
A 191

103. (1) Id-disposizzjonijiet ta’ dan l-artikolu g]andhom jg]oddu meta uffi`jal awtorizzat jeleva xi sustanza jew o[[ett, ]lief g]al dokument, fl-e\er`izzju ta’ dritt b]al dak spe`ifikat fl-artikolu

102(4) u (6).
(2) Jekk persuna li, skond l-artikolu 102(5) jkollha jedd ti[i informata bil-qbid ta’ o[[ett hekk titlob, kemm fil-waqt tal-qbid kemm f’xi waqt ie]or li ji[i wara, u li ma jkunx ja]bat aktar tard minn wie]ed u g]oxrin [urnata wara li tkun [iet informata bil-qbid, g]aldaqstant u bla ]sara g]al dawn id-disposizzjonijiet li [ejjin ta’ dan l-artikolu, l-uffi`jal awtorizzat g]andu jew:
(a) iwarrab kampjun tas-sustanza jew ta’ l-o[[ett elevat; jew
(b) jittratta dik is-sustanza jew dak l-o[[ett b]ala kampjun,
skond liema iqis l-aktar adatt meta titqies ix-xorta ta’ dik is-sustanza jew ta' dak l-o[[ett.
(3) Uffi`jal awtorizzat ma jkunx me]tie[ bis-sa]]a tas- subartikolu (2) iwarrab kampjun, jew jittratta sustanza jew o[[ett b]ala kampjun, jekk ix-xorta tas-sustanza jew ta’ l-o[[ett tkun tali li ma jkunx ra[onevolment prattikkabbli li ta[ixxi b’dak il-mod.
(4) Meta skond is-subartikolu (2) uffi`jal awtorizzat iwarrab kampjun, jew jittratta sustanza jew o[[ett b]ala kampjun, huwa g]andu jaqsmu fi tliet partijiet, hekk li kull parti ti[i mmarkata u si[illata jew marbuta b’dak il-mod li x-xorta tag]ha tkun tippermetti, u g]andu jag]ti parti wa]da minnhom lill-persuna li tkun g]amlet it- talba ta]t is-subartikolu (2).

104. (1) Persuna li tid]ol f’xi proprjetà jew f’xi fond, bastiment, in[enju ta’ l-ajru, posta jew post ie]or skond id- disposizzjonijiet ta’ l-artikolu 101, tista’ tkun akkompanjata minn kull persuna o]ra jew tie]u mag]ha dak it-tag]mir li jista’ jidhrilha li jkun me]tie[; u meta titlaq minn hemmhekk g]andha, jekk il- proprjetà ma tkunx okkupata jew jekk l-okkupant jew kull persuna o]ra li tkun qeg]da tie]u ]sieb il-bastiment, l-in[enju ta’ l-ajru, il- posta jew post ie]or tkun temporanjament assenti, t]alli hemmhekk mag]luq fi\-\gur kif kien.

(2) L-uffi`jal awtorizzat g]andu wkoll ikollu kull tali poter ie]or li jistg]u ji[u preskritti b’regolamenti mag]mulin mill-Ministru g]all-e\ekuzzjoni tal-funzjonijiet tieg]u kif imiss.

Kif tapplika pro`edura ta’ te]id ta’ kampjuni dwar sustanza jew o[[ett elevat.

Disposizzjonijie t supplimentari dwar id-dritt ta’ d]ul.

A 192

TAQSIMA VIII

G]arfien ta’ standards ekwivalenti.

Setg]a tal- Ministru li jag]mel regolamenti.

DISPOSIZZJONIJIET MIXXELLANJI
105. G]all-finijiet ta’ dan l-Att, il-Ministru jista’, bil-parir ta’ l- Awtorità dwar il-Li`enzjar, b’regolamenti jippreskrivi li xi disposizzjoni jew disposizzjonijiet dwar l-awtorizzazzjoni ta’ tqeg]id fis-suq ta’ prodott medi`inali g]andhom jitqiesu li jkunu [ew sodisfatti jekk standards ta’ manifattura, kwalità ta’ prodott medi`inali, sigurezza jew effika`ja, jew id-disposizzjonijiet dwar l- g]oti ta’ xi awtorizzazzjoni ta’ tqeg]id fis-suq ta’ xi pajji\ indikat f’dawk ir-regolamenti, jkunu [ew sodisfatti.

106. Il-Ministru jista’, wara konsultazzjoni ma’ l-Awtorità dwar il-Li`enzjar, jemenda l-iskedi ta]t dan l-Att, jippreskrivi b’regolamenti kull ]a[a li tista’ ti[i preskritta ta]t dan l-Att u jipprovdi dwar kull ]a[a li tirrigwarda prodott medi`inali, veleni u spi\eriji sabiex jag]ti effett iktar komplet lid-disposizzjonijiet ta’ dan l-Att, u b’mod partikolari, imma ming]ajr pre[udizzju g]all- [eneralità ta’ dak hawn qabel imsemmi, g]andu b’dawk ir- regolamenti jew xort’o]ra jipprovdi dwar:

(a) l-g]oti ta’ awtorizzazzjoni g]at-tqeg]id fis-suq;
(b) il-manifattura ta’ prodotti medi`inali u l-materjal grezz li jintu\a f’dik il-manifattura;
(`) id-distribuzzjoni bl-ingrossa ta’ prodotti medi`inali; (d) il-bejg] u l-forniment ta’ prodotti medi`inali;
(e) il-li`enzjar ta’ spi\eriji;
(f) ir-rappurtar ta’ reazzjonijiet medi`inali avversi;
(g) ir-reklamar ta’ prodotti medi`inali, u l- pre\entazzjoni u l-informazzjoni li jidda]]lu fir-reklam:
I\da r-reklamar ta’ `erti prodotti medi`inali jew klassijiet ta’ prodotti medi`inali jista' b'dawk ir-regolamenti, jkun projbit;
(h) it-tmexxija ta’ esperimenti klini`i;
(i) il-klassifikazzjoni ta’ prodotti medi`inali; (j) l-ittestjar ta’ prodotti medi`inali;
(k) ir-regolament ta’ prodotti medi`inali omeopati`i;
A 193
radjofarma`ewti`i u prodotti medi`inali li jinkisbu mid-demm tal-bniedem u plasma tal-bniedem; prodotti immunolo[i`i, u prodotti erbali;
(l) il-kompiti u r-responsabbiltajiet li jkollu detentur ta’
li`enza jew ta' awtorizzazzjoni;
(m) il-kompiti u r-responsabbiltajiet ta’ spi\jar responsabbli, persuna responsabbli u persuna kwalifikata;
(n) standards ta’ prattika tajba fil-manifattura, bejg] bl- ingrossa, distribuzzjoni u dispensa ta’ prodotti medi`inali:
I\da fil-ka\ ta’ standards ta’ dispensa l-Ministru jista’ wkoll jie]u l-parir tal-Bord dwar l-Ispi\jara;
(o) l-g]arfien ta’ standards ekwivalenti g]all-kwalità u l-effika`ja ta’ prodotti medi`inali dwar dawk il-pajji\i li jistg]u ji[u hekk preskritti;
(p) l-g]arfien ta’ standards ekwivalenti g]al prattika tajba fil-manifattura dwar dawk il-pajji\i li jistg]u ji[u hekk preskritti;
(q) id-drittijiet li jistg]u jin[abru mill-Awtorità dwar il- Li`enzjar u mill-Awtorità dwar il-Medi`ini;
(r) e``ezzjonijiet li jistg]u jsiru g]al xi disposizzjoni fl- interess tas-sa]]a pubblika.

107. Podotti medi`inali li jkunu fis-suq fid-data tad-d]ul fis- se]] ta’ l-artikolu 20 g]andhom ikunu so[[etti g]ad-disposizzjonijiet ta’ dak l-artikolu biss f’dak il-waqt u kif so[[etti g]al dawk il- kondizzjonijiet li jistg]u b’regoli ji[u stabbiliti mill-Awtorità dwar il- Li`enzjar.

108. L-Ordinanza dwar il-Professjoni Medika u l-Professjonijiet li g]andhom x’jaqsmu mag]ha g]andha ti[i emendata kif [ej:

(a) g]al dak li jirrigwarda spi\eriji: l-artikoli 22, 23, 25,
26, 27, 28, 30, 31, 33, 34, 35, 36, 37, 38, 39, 41, 42 u 48 g]andhom ji[u m]assra; u
(b) g]al dak li jirrigwarda velenu: l-artikoli 88, 89, 92,
93 u 95 g]andhom ji[u m]assra.

109. (1) Regolamenti mag]mulin ta]t id-disposizzjonijiet, ta' l-Ordinanza dwar il-Professjoni Medika u l-Professjonijiet li g]andhom x’jaqsmu mag]ha, li qed ji[u revokati bl-artikolu 108,

Disposizzjoni transitorja.

Emendi g]all- Ordinanza dwar il-Professjoni Medika u l- Professjonijiet li g]andhom x’jaqsmu mag]ha.

Kap. 31.

Riserva.

A 194
g]andhom, sakemm ma jsirx provvediment ta]t jew bis-sa]]a ta’ dan l-Att, jibqg]u jse]]u u jkollhom effett b]allikieku mag]mulin ta]t dan l-Att.
(2) Kull li`enza, permess jew awtorizzazzjoni o]ra mog]tija ta]t kull disposizzjoni ta' l-artikoli m]assra hawn qabel imsemmija, g]andhom jibqg]u fis-se]] b]allikieku kienu li`enza, permess jew awtorizzazzjoni mog]tija ta]t disposizzjoni jew awtorità korrispondenti mog]tija ta]t dan l-Att u g]andhom ji[u ttrattati u jsir minnhom skond hekk.
(3) Kull azzjoni me]uda jew pro`edimenti mibdija kontra jew dwar xi persuna ta]t xi disposizzjoni ta' l-artikoli m]assra hawn qabel imsemmija, g]andhom ikomplu jkollhom effett b]allikieku kienu xi azzjoni jew pro`edimenti me]uda jew mibdija ta]t xi disposizzjoni korrispondenti ta’ dan l-Att.
L-EWWEL SKEDA
Oqsma ta’ kompetenza
Anatomija Anestesjolo[ija Apparat mediku Biokimika
Bjolo[ija molekulari Dentistrija Dermatolo[ija Djabete
Ematolo[ija Endokrinolo[ija Epidemjolo[ija Erbali Farmakolo[ija
A 195
Farmakognosija Fi\jolo[ija Gastroenterolo[ija
{enetika Gerjatrija Immunolo[ija Kardjolo[ija Kimika analitika
Kimika farma`ewtika Kirur[ija Kosmi`ewti`i
Kura intensiva Medi`ina tal-Familja Medi`ina interna Medi`ina Respiratorja Medi`ina Trasfu\jonali
Medi`ina tal-Widnejn, Imnie]er u Grie\em Microbjolo[ija (b]al Virolo[ija, Batterjolo[ija) Nefrolo[ija
Newrolo[ija Nutra`ewti`i Nutrizzjoni Oftalmolo[ija Omeopatika Onkolo[ija
A 196
Ortopedija
Ostetrika u {inekolo[ija
Patolo[ija
Pedjatrija
Prodotti bioteknolo[i`i Prodotti mid-demm Psikjatrija Radjofarma`ewti`i Radjolo[ija Rewmatolo[ija Statistika medika
Teknolo[ija farma`ewtika
Tossikolo[ija Urolo[ija Va``inazzjoni
IT-TIENI SKEDA
Pro`edimenti tal-Bord ta’ Revi\joni dwar il-Medi`ini
1. Il-membri kollha tal-Bord ta’ Revi\joni dwar il-Medi`ini g]andhom ikunu pre\enti g]as-smig] ta’ xi appell jew il- formulazzjoni ta’ fehma ulterjuri.
2. Il-membri kollha tal-Bord ikollhom vot u l-fehma tal-Bord g]andha tirrifletti l-fehma tal-ma[[oranza tal-membri:
I\da membru li ma jaqbilx jista’ wkoll jitlob li l-fehma tieg]u tintehme\ mar-rapport tal-fehma tal-Bord b]ala rapport minoritarju.
3. L-appellant g]andu jidher quddiem il-Bord jew personalment jew kif rappre\entat minn xi a[ent fil-[urnata u l-]in
A 197
appuntati g]as-smig], jag]mel is-sottomissjonijiet tieg]u u j[ib dawk il-provi li l-Bord jista’ j]alli li jin[iebu:
I\da l-Bord jista’ jippostponi s-smig] ta’ l-appell jekk ikun sodisfatt li l-appellant ma setax jidher quddiemu min]abba f’mard jew assenza minn Malta jew g]al xi kaw\a ra[onevoli o]ra simili.
4. Il-Bord g]andu jag]ti lill-Awtorità dwar il-Medi`ini l- opportunità li tag]mel is-sottomissjonijiet tag]ha b’[ustifikazzjoni tal-fehma jew fehmiet li jkollha, u li [[ib kull prova li l-Bord jista’ jqis li tkun me]tie[a.
5. Il-Bord ikollu s-setg]a j]arrek xhieda u jag]ti l-[urament lil kull min jidher quddiemu.
6. Il-Bord ikollu s-setg]a jikkonferma jew inkella jo]ro[ fehma differenti minn dik li jsir appell kontriha, skond ma jista’ jqis li jkun xieraq.
7. Il-fehma tal-Bord g]andha tkun wa]da finali g]ad li ma tkunx skond id-de`i\joni ta’ l-Awtorità dwar il-Li`enzjar u ma jista’ jsir ebda appell minnha ]lief fuq xi punt ta’ li[i biss.
8. Bla ]sara g]ad-disposizzjonijiet ta’ qabel u g]ad- disposizzjonijiet ta’ dan l-Att, il-Bord jirregola l-pro`edura tieg]u nnifsu.
IT-TIELET SKEDA
Kondizzjonijiet u kriterji li jistabbilixxu jekk persuna g]andha jew m’g]andhiex interess dirett jew indirett fi spi\erija
(1) }add ma jkollu dritt g]al li`enza ta’ spi\erija jekk ikun tabib, kirurgu dentali, dentist jew veterinarju jew jekk ikun il-mara jew ir-ra[el ta’ tabib, kirurgu dentali, dentist jew veterinarju.
(2) Ebda li`enza ma ting]ata jew ti[[edded jekk tabib, kirurgu dentali, dentist jew veterinarju g]andu interess dirett jew indirett fl- ispi\erija.
(3) Ebda tabib, kirurgu dentali, dentist jew veterinarju jew
]addie]or awtorizzat minnhom biex jo]ro[ preskrizzjonijiet ta]t l-Att dwar il-Medi`ini jew Att ie]or, ma jista’ jag]mel qbil ma spi\jar jew
]addie]or sabiex ikollu sehem mill-profitti ta’ l-ispi\erija, jew li jkollu interess dirett jew indirett ta’ kwalunkwe xorta fi kwalunkwe spi\erija.
A 198
(4) Ebda spi\jar ma jista’:
(a) imexxi spe\erija g]al, jew bi ftehim ma’ tabib, kirurgu dentali, dentist jew veterinarju jew ]addie]or awtorizzat minnhom biex jo]ro[ preskrizzjonijiet ta]t l-Att dwar il- Medi`ini jew Att ie]or;
(b) li jag]mel ftehim ma’ tabib, kirurgu dentali, dentist jew veterinarju jew ]addie]or awtorizzat minnhom biex jo]ro[ preskrizzjonijiet kif di[à msemmi biex ikollu sehem fil-profitti mill-ispi\erija;
(`) li jislef ismu sabiex l-ispi\erija tin\amm minn
]addie]or.
Mg]oddi mill-Kamra tad-Deputati fis-Seduta Nru. 875 tal-25 ta’ Frar, 2003.
ANTON TABONE

Speaker

RICHARD J. CAUCHI

Skrivan tal-Kamra tad-Deputati

A 199

MEDICINES ACT, 2003

Arrangement of Articles
1. Short title and commencement
PART I - PRELIMINARY
2. Interpretation
PART II - ADMINISTRATION

TITLE I - Licensing Authority

3. Functions of the Licensing Authority

TITLE II - The Medicines Authority

4. Establishment of the Medicines Authority
5. Legal personality of the Authority
6. Functions of the Medicines Authority
7. Organisation of the Medicines Authority
8. The Chief Executive Officer of the Medicines Authority
9. Employees of the Medicines Authority
10. Accounts of the Medicines Authority
11. Procurement by the Authority
12. Applicability of Code of Ethics
13. Exemption from tax, etc.

TITLE III - Medicines Review Board

14. Establishment of Medicines Review Board
15. Medicines Review Board may appoint advisors
16. Functions of the Medicines Review Board
17. Procedure of appeals
18. Public hearing

A 201
41. Suspension or revocation of a manufacturer's licence
42. Inspection in relation to manufacturer, etc
43. Duration and renewal of manufacturer, etc
44. Responsibilities of manufacturer's licence holder
45. Responsibilities of the qualified person
46. Suspension of activity of a qualified person
47. Change in conditions of manufacturer's licence
48. Obligations of the Licensing Authority
49. Manufacture of homeopathic medicinal products
50. Manufacturing of medicinal products derived from human blood and human plasma
51. Manufacture of radiopharmaceuticals
52. Immunological medicinal products
53. Herbal medicinal products

TITLE III - Wholesale Distribution of Medicinal Products for Human Use

54. Wholesale dealing
55. Application for a wholesale dealer's licence
56. Granting of a wholesale dealer's licence
57. Notice for further information
58. Duration and renewal of wholesale dealer's licence
59. Obligations of holder of wholesale dealer's licence
60. Responsibility of the responsible persons
61. Suspension or revocation of wholesale dealers licence
62. Change in conditions of a wholesale dealer's licence
63. Obligations of Licensing Authority
64. Inspecting in relation to wholesale

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89. Opening of pharmacies
PART IV - POISONOUS SUBSTANCES
90. Definition of poisons
91. Keeping etc of poisons
92. Licence for sale of poisons
93. Keeping of poisonous substances in a safe place
94. Sale of poisonous substances
95. Power of inspection
96. Poisoned grain, seed etc
PART V - OTHER DEALINGS WITH MEDICINAL PRODUCTS
97. Special restrictions on persons to be supplied with medicinal products
98. Adulteration of medicinal products
PART VI - OFFENCES AND PENALTIES
99. Offences and penalties
100. Special Procedure
PART VII - ENFORCEMENT
101. Right of entry
102. Power to inspect, take samples and seize goods and documents
103. Application of sampling procedure to substance or article seized
104. Supplementary provisions as to rights of entry and related rights
PART VIII - MISCELLANEOUS PROVISIONS
105. Recognition of equivalent standards
106. Power of Minister to make regulations
107. Transitory provision
108. Amendment of the Medical and Kindred Professions Ordinance
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109. Saving
First Schedule - Panel of experts to sit on Medicines Review Board
Second Schedule - Proceedings of the Medicines Review Board
Third Schedule - Conditions and criteria where any person can have or not have a direct or indirect interest in a pharmacy
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I assent.
(L.S.) GUIDO DE MARCO
President
5th March, 2003

ACT No. III of 2003

AN ACT to make provision for matters connected with the manufacture, preparation and assembly, wholesale distribution, storage, destruction, disposal, advertising and authorisation of medicinal products and any activity connected therewith and the regulation of the sale of medicinal products, pharmacies and related pharmaceutical activities and for any other matters ancillary thereto or connected therewith.

BE IT ENACTED by the President, by and with the advice and consent of the House of Representatives, in this present Parliament assembled, and by the authority of the same, as follows:-

1. (1) The short title of this Act is the Medicines Act,

2003.
(2) This Act shall come into force on such date as the Minister responsible for health may by notice in the Gazette appoint, and different dates may be so appointed for different provisions or different purposes of this Act.

PART I

PRELIMINARY

2. In this Act, unless the context otherwise requires - "advertising" in relation to medicinal products includes any

form of door-to-door information, canvassing activity or inducement
designed to promote the prescription, supply, sale or consumption of medicinal products and without prejudice to the generality of the

Short title and commencement.

Interpretation.

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foregoing in particular includes:
(a) the advertising of medicinal products to the general public;
(b) the advertising of medicinal products to persons qualified to prescribe or supply them;
(c) visits by medical or sales representatives to persons qualified to prescribe medicinal products;
(d) the supply of samples;
(e) the provision of inducements to prescribe or supply medicinal products, by way of a gift, offer or promise of any benefit or bonus, whether in money or in kind, except when the intrinsic value of such an inducement is minimal;
(f) sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products;
(g) sponsorship of any scientific congress attended by persons qualified to prescribe or supply medicinal products and in particular where payment of their travelling and accommodation expenses is offered in connection therewith;
but shall exclude:
(i) the labelling and the accompanying package leaflets, as may be specified in accordance with the provisions of Part III, Title I of this Act;
(ii) correspondence, even if accompanied by material of a non-promotional nature, which is in reply to a specific question about a particular medicinal product;
(iii) factual, informative, announcement or reference material relating to pack changes, adverse- reaction warnings as part of general drug precautions, trade catalogues, price lists and other material of a similar nature provided that such material does not include any product claim;
(iv) any statement relating to human health or disease, provided there is no reference, whether direct or indirect, to a medicinal product;
"analysis" includes testing of a medicinal product or any of its
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constituents, both active or inactive, in respect of their chemical, physical, pharmaceutical, biological, toxicological or pharmacological properties;
"assemble", in relation to a medicinal product, means to enclose the product in a container which is labelled before the product is sold or supplied, or, where the product is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied in it, and shall also include the act of introducing approved information in or on the container and "assembly" shall be construed accordingly;
"authorised officer" in relation to the Medicines Authority means any officer or employee of the Authority or any other person authorised by the Authority to act on its behalf and in relation to the Licensing Authority means any officer or employee of the Department as referred to in article 5 of the Department of Health (Constitution) Ordinance authorised by the Licensing Authority to act on its behalf;
"business" means any economic activity whether carried out by the individual or by a body of persons, whether corporate or unincorporate and includes the exercise of a profession;
"clinical trial" means any investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal product under investigation, or to identify any adverse reactions to one or more medicinal product under investigation or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product with the object of ascertaining its safety or efficacy; and includes clinical trials carried out in either one site or multiple sites, whether locally or in one or more states recognised by the Licensing Authority;
"composition" in relation to a medicinal product, means the ingredients constituting it and the proportions, and the degrees of strength, quality and purity, in which those ingredients are respectively contained in it and as may be established in a recognised pharmacopoeia;
"container" in relation to a medicinal product, means the immediate packaging or outer packaging;
"cosmetic product" shall have the same definition as found under the Product Safety Act;

Cap. 94.

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Cap. 31.

"dental practitioner" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance or any other law replacing the same;
"disease" includes any injury, ailment or adverse condition, whether of body or mind;
"dispensing" includes sale or supply of medicinal products; "foodstuff" shall have the same meaning as that under the Food
Safety Act;
"good practice" in relation to manufacturing practice, laboratory practice, distribution practice, clinical practice and dispensing practice means the standards for the proper execution of the relative activity as established by or under this Act;
"herbal medicinal product" means any medicinal product containing as active ingredients one or more herbal substances or one or more herbal preparations or one or more herbal substances in combination with one or more such herbal preparations;
"herbal preparations" means preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration and fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates;
"herbal substances" means all mainly whole, fragmented or cut plants, plant parts, algae, funghi, lichen in an unprocessed, usually in dried form but sometimes fresh. Certain exudates which have not been subjected to a specific treatment are also considered to be herbal substances;
"homeopathic medicinal product" means any medicinal product prepared from products, substances or compositions referred to as homeopathic stocks in terms of a homeopathic manufacturing procedure described by a recognised Pharmacopoeia;
"immediate packaging" means the container or other form of packaging immediately in contact with the medicinal product;
"immunological medicinal product" means any medicinal product consisting of vaccine, toxin, serum or allergen product where:
(a) vaccine, toxin and serum include -
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(i) agents used to produce active immunity; (ii) agents used to diagnose immunity;
(iii) agents used to produce passive immunity; and
(b) ''allergen product'' means any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergising agent;
"ingredient" in relation to the manufacture or the preparation of a substance, includes anything which is the sole active ingredient of the substance as manufactured or prepared;
"investigational medicinal product" means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, and includes products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form;
"labelling" means any information on the immediate or outer packaging;
Act;
"licence" means a licence issued under the provisions of this
"licensee" means any person who is the holder of a licence for a particular activity granted under this Act;
"magistral formula" means any medicinal product prepared in a pharmacy in accordance with a prescription for an individual patient;
"manufacture", in relation to a medicinal product, includes any process carried out in the course of manufacturing the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it;
"medical device" means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including any software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of -
(a) diagnosis, prevention, monitoring, treatment or alleviation of disease;
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(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
(c) investigation, replacement or modification of the anatomy or of a physiological process; and
(d) control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
"medical practitioner" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance or any other law replacing same;
"medicinal prescription" means any prescription issued by a professional person qualified to prescribe medicinal products by or under this Act;
"medicinal product" means any substance or combination of substances presented for treating or preventing disease in human beings, as well as any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings;
"medicinal purpose" includes any one or more of the following purposes:
(a) the treating or preventing disease;
(b) the diagnosing of disease or ascertaining the existence, degree or extent of a physiological condition;
(c) contraception;
(d) inducing anaesthesia;
(e) the prevention or interference with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function or in any other way.
"Medicines Authority" means the Authority established under article 4;
"Medicines Review Board" means the Board established under
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article 14;
"Minister" means the Minister responsible for public health; "official formula" means any medicinal product that is prepared
in a pharmacy in accordance with instructions found in a prescription of a recognised pharmacopoeia and which is intended to be supplied directly to a patient being served by the said pharmacy;
"outer packaging" means the packaging into which the immediate packaging is placed;
"package", in relation to any medicinal product, means any box, packet or other article in which one or more container of the product are, or are intended to be, enclosed, and, where any such box, packet or other article is, or is to be itself enclosed in one or more other boxes, packets or articles, includes any of the said boxes, packets or articles;
"package leaflet" means a leaflet containing information for the user which accompanies the medicinal product;
"pharmacist" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance, or any other law replacing the same;
"pharmacy technician" means a person authorised to act as such under the Medical Kindred and Profession Ordinance or any other law replacing the same;
"pre-packaging" means the act by which a pharmacist divides a medicinal product into quantities more appropriate for individual patient use, thus changing the outer packaging of this product for the act of dispensing;
"prescribed" means prescribed by regulations made by the
Minister under this Act;
"qualified person" means any person who is a qualified person in relation to a manufacturer’s licence as provided in article 38 (1)(e);
"radionuclide generator" means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and used in a radiopharmaceutical;
"radionuclide kit" means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually
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prior to its administration;
"radionuclide precursor" means any radionuclide not being a radiopharmaceutical, radionuclide generator or radionuclide kit which is produced for the radio-labelling of another substance prior to administration;
"radiopharmaceutical" means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose;
"recognised laboratory" means any laboratory recognised as such by the Licensing Authority for the purposes of this Act;
"recognised pharmacopeia" means a pharmacopeia recognised by rules for the purpose of this Act;
"responsible person" means any person who is a responsible person in relation to a wholesale dealer's licence as provided in article
55(1)(d);
"rules" means rules made by the Licensing Authority under the provisions of this Act;
"substance" means any matter irrespective of origin be it human (including human blood and human blood products), animal (including micro-organisms, whole animals, parts of organs, animal secretions, extracts), vegetable (including micro-organisms, plants, parts of plants, vegetable secretions, extracts), or chemical (including elements, naturally occurring chemical materials or chemical products obtained by chemical change or synthesis);
"Superintendent of Public Health" has the same meaning as is assigned to it by article 4 of the Department of Health (Constitution) Ordinance;
"veterinary surgeon" means a person who is authorised to exercise such profession under the Veterinary Services Act, 2002, or any other law replacing the same;
"wholesale distribution" in relation to a medicinal product, includes all activities consisting of procuring, holding, supplying, distributing, exporting or importing medicinal products, other than retail sale or for personal use.
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PART II

ADMINISTRATION

Title I - The Licensing Authority

3. (1) The Superintendent of Public Health shall be the

Licensing Authority for the purposes of this Act.
(2) The Licensing Authority shall have the following functions:
(a) to establish standards to ensure the quality, safety and efficacy of medicinal products;
(b) to establish standards for the operation of pharmacies;
(c) to establish standards for the manufacture, preparation, assembly, packing, packaging or re-packing and labelling of medicinal products or any substance which is used or is intended to be used in such products;
(d) to establish standards for the operation of wholesale distribution;
(e) to establish standards for the testing or analysis of medicinal products or any substance which is used or is intended to be used therein;
(f) to establish standards for the carrying out of clinical trials;
(g) to establish standards for the reporting of adverse reactions, serious adverse reactions or suspected unexpected adverse reactions and make provision for the collection or submission of related information from any person or activity regulated by or under this Act;
(h) to establish standards in relation to the advertising of medicinal products;
(i) to advise the Minister in the making of regulations in respect of the classification of medicinal products;
(j) to issue, renew, amend, vary, suspend or revoke marketing authorisations for medicinal products;

Functions of the Licensing Authority.

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(k) to withdraw or recall medicinal products from the market in the interest of public health ; and
(l) to ensure compliance with international obligations entered into by the Government of Malta in relation to any matter regulated by or under this Act;
(m) to issue, renew, amend, vary, suspend or revoke any authorisation or licence that may be required by or under this Act;
(n) to carry out inspections of any activity, service or procedures in relation to medicinal products and to do all such things as may be necessary for the purpose of ensuring compliance with any provisions of this Act, or made thereunder v;
(o) to authorise the advertising and promotion of medicinal products;
(p) to carry out any other activity as may be prescribed; (q) to advise the Minister on any matter connected with
its functions or any other provision of this Act.
(3) The Licensing Authority may by rules delegate any of its functions referred to in subarticle (2)(m) (n) and (o) to the Medicines Authority.
(4) The Licensing Authority shall levy such fees as may be prescribed for the purpose of this Act:
Provided that such regulations may provide for the waiving of such fees in such circumstances as may be prescribed.
(5) For the proper exercise of its functions, the Licensing Authority may establish advisory committees as it may deem necessary.

Establishment of the Medicines Authority.

Legal personality of the Medicines Authority.

Title II - The Medicines Authority

4. There shall be established a Medicines Authority, which shall be headed by a Chief Executive Officer.

5. (1) The Medicines Authority shall be a body corporate having a separate and distinct legal personality and shall be capable, subject only to the provisions of this Act, of entering into any contract, of acquiring, holding and disposing of any kind of property

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both movable and immovable, of employing personnel for the purposes of its operations; and of suing and being sued, and to which any function or operation of government are or may be assigned under this or any other law.
(2) The legal and judicial representation of the Medicines
Authority shall vest in the Chief Executive Officer:
Provided that the Medicines Authority may appoint one or more of its officers or employees to appear in its name and on its behalf in any judicial proceedings or in any act, contract, instrument or other document whatsoever.

6. (1) The Medicines Authority shall have the following functions:

(a) to carry out those such functions as may be delegated to it by the Licensing Authority in terms of article
3(3);
(b) to assist and advise the Licensing Authority on any matter relating to the regulation of medicinal products and related activities;
(c) to undertake such activities and projects as may be necessary or expedient for the proper exercise of its functions;
(d) to establish such procedures as may be necessary for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products to be placed on the market in Malta;
(e) to establish such procedures as may be necessary to make such assessments of medicinal product safety, quality and efficacy as it may deem necessary for those products to be placed on the market in Malta;
(f) to establish such procedures as may be necessary for monitoring and obtaining reports on the quality, safety or efficacy of medicinal products;
(g) to make recommendations to the Licensing
Authority in relation to standards and licensing;
(h) to advise the Licensing Authority on the precautions or restrictions to which medicinal products may be subjected for their marketing or continued use in Malta; and

Functions of the Medicines Authority.

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(i) to furnish, whenever it so thinks fit or is so requested by the Licensing Authority, advice or make recommendations to the Licensing Authority in relation to any matter connected with its functions.
(2) For the proper exercise of its functions, the Medicines Authority may require the production of such information or documents as may be necessary for any of its functions and may seek expert advice from any person, who is not a member of the Medicines Review Board, possessing the necessary qualifications and experience in the fields listed in the First Schedule, and may also establish such advisory committees as it may deem necessary, either for general or specific purposes.
(3) The Medicines Authority shall levy such fees as may be prescribed for the purposes of this Act:

Organisation of the Medicines Authority.

The Chief Executive Officer of the Medicines Authority.

Provided that such regulations may provide for the waiving of such fees in such exceptional circumstances as may be prescribed .

7. The Authority shall establish such Directorates as may be necessary, and shall assign to each such Directorate those functions which it may deem expedient for the proper exercise of its functions.

8. (1) The Chief Executive Officer shall be appointed by the Minister from amongst persons who are suitably qualified and experienced in the medical, pharmaceutical or medical science sector.

(2) The Chief Executive Officer shall be responsible for the overall management and performance of the Authority including the management of the day-to-day operations of the Authority.
(3) A person shall not be eligible to be appointed or to hold office as Director or Chief Executive Officer of the Authority if he:
(i) is a member of the House of Representatives;
or
(ii) is a Judge or a Magistrate; or
(iii) is legally incapacitated; or
(iv) has been declared bankrupt or has made a composition or arrangement with his creditors; or
(v) has been convicted of fraud or any other offence against public trust, or has otherwise been sentenced to a term of imprisonment for a term not less
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than three months; or
(vi) has a financial or other interest whether direct or indirect, in any enterprise or activity which is likely to affect the discharge of his functions as a member of the Authority.
(4) (a) The Chief Executive Officer of the Authority shall hold office for a period not exceeding five years and shall be eligible for re-appointment for further periods each not exceeding five years.
(b) The Chief Executive Officer of the Authority may be relieved from office by the Minister prior to the expiry of his term of office where, in the opinion of the Minister, he has been guilty of misconduct or on the ground of inability to continue to perform the functions of his office, whether due to infirmity of mind or of body, or to any other cause, or of misbehaviour.

9. (1) Subject to the provisions of the Constitution and of any other enactment applicable thereto, and without prejudice to the other provisions of this Act, the appointment of officers or employees of the Authority shall be made by the Authority. The terms and conditions of employment shall be established by the Authority with the concurrence of the Minister, given after consultation with the Minister responsible for finance.

(2) The Prime Minister may, at the request of the Authority after it consults with the Minister, from time to time and by direction detail a public officer for duty with the Authority in such a capacity and for such term and under such conditions as may be established in relation to the officer so detailed.
(3) The Prime Minister may at any time revoke any such direction given under subarticle (2).
(4) Where an officer is detailed for duty with the Authority such officer shall, during the time in which such a direction is in force, be under the administrative direction and control of the Chief Executive Officer and shall otherwise remain and retain all rights and duties as a public officer and for the purposes of any law relating to government service pension, service with the Authority shall be deemed to be service with the Government:
Provided that no account shall be taken in assessing the pensionable emoluments of such officer for the purposes of any law relating to government service pensions of any allowances, bonuses or gratuities paid to such officer by the Authority in excess to what he is entitled as a public officer:

Employees of the Medicines Authority.

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Accounts of the Medicines Authority.

Procurement by the Medicines Authority.

Applicability of the Code of Ethics.

Exemption from tax, etc.

Provided further that during the time in respect of which he is so detailed to perform duties with the Authority the terms and conditions of his service shall not be less favourable than those which are attached to his appointment under the Government during the period aforesaid. Such terms and conditions shall not be deemed to be less favourable merely because they are not in all respects identical with or superior to those enjoyed by the officer concerned at the date of such offer, if such terms and conditions, taken as a whole, in the opinion of the Prime Minister offer substantially equivalent or greater benefits.

10. (1) The Authority shall keep proper books of account in such manner as the Minister of Finance may from time to time direct. Such accounts shall be audited by an auditor appointed for the purpose by the Authority and shall moreover be subject to audit by the Auditor General.

(2) The Authority shall, not later than six weeks after the end of each financial year, present to the Minister and the permanent secretary the audited accounts together with a report on the workings of the agency which report shall state the manner in which the agency has operated to fulfil its functions and its plans in the future.
(3) The reports referred to in subarticle (2) shall be laid on the Table of the House of Representatives by the Minister not later than six weeks after its receipt, or where the House is during the period not in session not later than the second week after the House resumes its sittings.

11. Except with the approval of the Minister, the Authority shall not enter into any contract for the supply of goods or materials or for the execution of work or for the rendering of services, to or for the benefit of the Authority, which is estimated by the Authority to involve an expenditure exceeding one hundred thousand liri or such other amount as the Minister may from time to time direct in writing, except after notice of the intention of the Authority to enter into such contract has been published and competitive tenders have been issued.

12. The Chief Executive Officer and all other executive officers and employees of the Authority shall conform with and abide by any public service values and Code of Ethics that may be in force from time to time in relation to public officers.

13. The Authority shall be exempt from any liability for the payment of any tax on income or duty on documents for the time being in force in Malta.

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Title III - Medicines Review Board

14. (1) There shall be a Medicines Review Board which shall be composed of three members and three substitute members appointed by the Minister, as follows:

(a) a person who shall be a legal practitioner having at least seven years’ legal experience who shall act as the chairperson; and
(b) two other persons who possess the technical and scientific qualifications and experience in the field of regulation of medicinals.
(2) The Minister shall designate a public officer to act as secretary for the Medicines Review Board.
(3) The members of the Medicines Review Board shall be appointed by the Minister for a term of three years under such terms and conditions as may be specified in their appointment. Members so appointed may be re-appointed on the expiration of their term of office.
(4) Where any member of the Medicines Review Board is unable to act, the substitute member having the same qualifications shall act in his stead.
(5) A person shall not be qualified to hold office as a member or substitute member of the Medicines Review Board if he:

Establishment of Medicines Review Board.

(i) is a member of the House of Representatives, or
(ii) is a Judge or a Magistrate; or
(iii) is legally incapacitated; or
(iv) has been declared bankrupt or has made a composition or arrangement with his creditors; or
(v) has been convicted of fraud or any other offence against public trust, or has otherwise been sentenced to a term of imprisonment for a term not less than three months; or
(vi) has a financial or other interest, whether direct or indirect, in any enterprise or activity which is likely to affect the discharge of his functions as a member
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Cap. 12.

Medicines Review Board may appoint advisors.

Functions of the Medicines Review Board.

of the Board.
(6) The provisions of Sub-title II of Title II of Book Third of the Code of Organization and Civil Procedure shall, mutatis mutandis, apply to members of the Medicines Review Board who may be challenged or may abstain from sitting on that Board during the hearing of an appeal.
(7) A person shall cease to be a member of the Medicines Review Board at the expiration of his term of office, or if any circumstances arise that, if he were not a member of the Medicines Review Board, he would cease to be qualified for such appointment.
(8) A member of the Medicines Review Board may be removed from office by the Minister if, in his opinion, such member is no longer fit to continue in office or has become incapable of properly performing his duties as a member.

15. (1) In the execution of its functions, the Medicines Review Board may seek the advice of any knowledgeable person on any matter which is the subject of an appeal being heard.

(2) The Board may also require any government department and, or authority to provide it with such information or advice it may deem necessary for the proper exercise of its functions.

16. (1) It shall be the function of the Medicines Review

Board:
(a) to hear any appeal made by any person aggrieved by any recommendation of the Medicines Authority in relation to the safety, quality and efficacy of a medicinal product following an application for a marketing authorisation submitted by the appellant;
(b) to provide advice and make its recommendations to the Licensing Authority regarding any appeal or request made to it.
(2) Concurrently with the submission of its recommendations to the Licensing Authority, the Board shall also submit a copy of such recommendations to the appellant and to the Medicines Authority.
(3) Any administrative and financial support required by the Medicines Review Board for the performance of its functions shall be provided by the Licensing Authority.
(4) Subject to the foregoing provisions the business of the
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Medicines Review Board shall be conducted in accordance with the rules contained in the Second Schedule and otherwise the Board may regulate its own procedure.

17. (1) Where an applicant for a marketing authorisation feels aggrieved by the findings and recommendations made by the Medicines Authority to the Licensing Authority, he may, within fourteen days of the receipt of a copy of such findings and recommendations, file an appeal with the Medicines Review Board.

(2) The Licensing Authority may, if it deems it necessary, within fourteen days of the receipt of the findings and recommendations of the Medicines Authority on the safety, quality and efficacy of a medicinal product, request the Medicines Review Board to provide it with a second opinion on the case.
(3) Any appeal or request for review shall be made in writing and shall be accompanied by the prescribed fee.
(4) The application for an appeal or request for review shall clearly and comprehensively state the grounds for the appeal or review and shall provide all evidence and documentation to sustain any claim made and which may be necessary to enable the Board to decide on the case:
Provided that the Medicines Review Board may require the submission of such further information or documentation as it may deem necessary:
Provided further that the Medicines Review Board shall after obtaining all the relevant information, process the application within a time limit specified in regulations made under this Act.

18. (1) The Medicines Review Board shall appoint the matter for public hearing within thirty days of the day of filing of the appeal or request for review and shall decide the matter as expeditiously as possible.

(2) The Medicines Review Board will inform the appellant, the Licensing Authority and the Medicines Authority of its opinion in writing as soon as is practicable.

Procedure of appeal.

Public hearing.

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PART III

GENERAL PROVISIONS

Applicability of certain provisions.

Authorisation to place medicinal products on the market.

Title I - Marketing Authorisation Relating to Medicinal Products

19. (1) The provisions of articles 20 to 36 shall apply to industrially produced medicinal products for human use intended to be placed on the market in Malta.

(2) Articles 20 to 36 shall not apply to -
(a) any medicinal product prepared in accordance with a magistral formula;
(b) any medicinal product prepared in accordance with an official formula;
(c) medicinal products intended for research and development trials;
(d) intermediate products intended for further processing by an authorised manufacturer;
(e) radionuclides in the form of sealed sources.

20. (1) No person shall place a medicinal product on the market in Malta unless he is in possession of a marketing authorisation from the Licensing Authority, in accordance with the provisions of this Act or any regulations or rules made thereunder:

Provided that the Licensing Authority may, in exceptional cases, allow the use of a medicinal product without a marketing authorisation subject to such conditions as it may attach to it:
Provided further that a medicinal product that is essentially identical to a medicinal product for which a marketing authorisation has already been granted shall only be subject to conditions as may be determined by the Licensing Authority.
(2) Any application for the grant of a marketing authorisation shall be made to the Licensing Authority and shall be accompanied by the prescribed fee.
(3) The application shall contain all the information and documents necessary for the assessment of the safety, quality and efficacy of the medicinal product and shall be submitted in such form and manner as the Licensing Authority may by rules require.
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(4) The Licensing Authority shall forward the application submitted to it to the Medicines Authority as soon as possible.
(5) Where an application for the issue of a marketing authorisation is received by the Medicines Authority, the Authority may -
(a) refuse to process the application if such application is not submitted in accordance with the provisions of this Act;
(b) request the applicant to furnish it with such further information relating to the application as it may consider necessary; and where any such request has been made, the Medicines Authority shall not be required to determine the application until the information as requested has been submitted to it;
(c) assess the application in respect of medicinal product safety, quality and efficacy in such a manner and within such period as may be prescribed by or under this Act; and
(d) carry out any other activity as may be prescribed by the Minister from time to time.
(6) The Medicines Authority shall report its findings and make its recommendations to the Licensing Authority, and shall submit a copy thereof to the applicant, in such a manner and within such period as may be prescribed.

21. Where the Licensing Authority or the applicant disagree with the findings or recommendations of the Medicines Authority, either party may lodge an appeal to the Medicines Review Board in the manner established under this Act.

22. (1) On receipt of the findings and recommendations of the Medicines Authority, or following an appeal or a request for a review by the Medicines Review Board, the Licensing Authority may refuse or otherwise issue a marketing authorisation either as recommended by the Medicines Authority or subject to any such condition or obligation as it may deem necessary.

(2) The decision of the Licensing Authority shall be final and together with the detailed reasons for such decision shall be communicated to the Medicines Review Board, the Medicines Authority and the applicant as necessary.

23. (1) In granting or refusing a marketing authorisation, the Licensing Authority shall also inform the Medicines Authority of

Review or appeal.

Granting of marketing authorisation.

Notification of marketing authorisation.

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such a decision.
(2) A marketing authorisation shall specify:
(a) the summary of product characteristics as approved; (b) the approved labelling and packaging;
(c) any conditions that may be attached to the granting of the marketing authorisation;
(d) the classification of the medicinal product;
(e) the term of validity of the marketing authorisation;

Validity of market authorisation.

Application of renewal.

Notification of refusal.

Refusal to renew marketing authorisation.

(f) any other specification that the Licensing Authority may deem necessary.

24. (1) Every marketing authorisation granted under this

Act, shall unless previously revoked, expire at the end of its validity.
(2) Every marketing authorisation so granted under this Act shall unless previously revoked, be renewable upon an application by the holder made at least three months before the expiry of the period of validity.

25. (1) Where an application for the renewal of a marketing authorisation under this Act has been duly made, the validity of the marketing authorisation shall be deemed to continue to have effect until such time as the Licensing Authority has determined the application.

(2) Notwithstanding the provisions of any other law, no court may issue a warrant of prohibitory injunction restraining the Licensing Authority from determinining any such application.

26. The Licensing Authority shall refer an application for renewal of a marketing authorisation to the Medicines Authority, and in such case the provisions of article 20(4), (5) and (6) and of article

21 shall, mutatis mutandis apply.

27. (1) The Licensing Authority may refuse to grant or renew the marketing authorisation on the basis of poor quality, safety and efficacy of the medicinal product or in the interest of public health or any other reason that would normally be a valid reason for the suspension, revocation or refusal of a marketing authorisation:

Provided that the Licensing Authority shall notify the
Medicines Authority and the applicant of the decision giving detailed
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reasons for such decision.
(2) A renewal of a marketing authorisation shall specify -
(a) the summary of product characteristics as approved; (b) the approved labelling and packaging;
(c) any conditions that may be attached to the granting of the marketing authorisation;
(d) the classification of the medicinal product;
(e) the term of validity of the marketing authorisation;
(f) any other specification that the Licensing Authority may deem necessary.

28. (1) The Licensing Authority shall suspend or revoke a marketing authorisation for a medicinal product where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. For the purpose of this article therapeutic efficacy shall be deemed to be lacking when it is established that therapeutic results cannot normally be obtained with the medicinal product.

(2) An authorisation shall also be suspended or revoked where the particulars supporting the application as provided for in this Act are found to be incorrect or have been amended without authorisation or when the requisite controls required by or under this Act have not been carried out.
(3) When the packaging, labelling or the package leaflet of the medicinal product in question do not comply with the requirements as specified by or under this Act, the Licensing Authority may suspend the marketing authorisation by notice served on the holder of the marketing authorisation concerned and the suspension shall continue to have effect until the Licensing Authority is satisfied that the requirements have been fulfilled.
(4) If the Licensing Authority suspends or revokes a marketing authorisation, it shall notify the holder of the marketing authorisation and the Medicines Authority of such decision stating in detail the reasons on which such a decision is based.
(5) The holder of the marketing authorisation may, within fourteen days of such notification, request the Medicines Review

Suspension or revocation of marketing authorisation.

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Board to examine the circumstances leading to the suspension or the revocation of the marketing authorisation, and the Medicines Review Board shall make its recommendations on the matter to the Licensing Authority:

Classification of medicinal products.

List of medicinal products having a marketing authorisation.

Provided that the request shall not suspend the effects of the decision of the Licensing Authority and that the Licensing Authority shall not be bound by the recommendations made by the Medical Review Board.

29. (1) When a marketing authorisation is granted or renewed, the Licensing Authority shall specify the classification of the medicinal product in accordance with the provisions of this Act, but in general into:

(a) a medicinal product subject to a medicinal prescription; or
(b) a medicinal product not subject to a medicinal prescription, where such medicinal product is considered that with reasonable safety it can be sold or supplied by or under the supervision of a pharmacist unless otherwise provided for by this Act that a medicinal product under paragraph (b) of subarticle (1) is classified under paragraph (a) of subarticle (1).
(2) The Licensing Authority may by rules determine the type, content and presentation or otherwise of a prescription and who is authorised to issue the said prescription that may be needed for a medicinal product or class of medicinal products.

30. (1) The Licensing Authority shall, at least annually, publish in the Gazette a list specifying -

(a) the medicinal products that have a valid marketing authorisation;
(b) the medicinal products which may only be sold by prescription; and
(c) where applicable, the type of prescription required and the person or persons authorised to issue the said prescription.
(2) Whenever a marketing authorisation has been issued in relation to a medicinal product the Licensing Authority shall publish in the Gazette the information specified in subarticle (1)(a), (b) and (c) and such publication shall be deemed to amend the list of medicinal products issued under subarticle (1).
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(3) The Licensing Authority shall publish in the Gazette, as soon as is practical, the list of medicinal products for which the marketing authorisation has been suspended or revoked and such publication shall be deemed to amend the list of medicinal products issued under subarticle (1).

31. A medicinal product may only be advertised in accordance with such conditions as may be established by or under this Act.

32. The provisions of this Part shall apply to homeopathic medicinal products for human use except for homeopathic medicinal products which:

(a) are administered orally and externally, subject to such regulations as may be made by the Minister in respect thereof;
(b) have no specific therapeutic indication appearing on the labelling of the medicinal product or in any information relating thereto; and
(c) have a sufficient degree of dilution to guarantee the safety of the medicinal product, in particular, the medicinal product may not contain either more than one part per 10,000 of
the mother tincture or more than 1/100th of the smallest dose
used in allopathy with regard to active principles whose presence in an allopathic medicinal product results in the obligation to submit a medicinal prescription.

33. The provisions of this Part shall apply to medicinal products based on blood constituents which are prepared industrially by a private or a public establishment but shall not apply to blood, plasma or blood cells of human origin.

34. The marketing authorisation referred to in article 20 shall be required for generators, kits, precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals other than radiopharmaceuticals prepared at the time of use by a person or by an establishment authorised, under this Act, to use such medicinal products in an approved health care establishment exclusively from authorised generators, kits or precursor radiopharmaceuticals in accordance with the manufacturer's instructions.

35. (1) The provisions of this Part shall apply to immunological medicinal products.

(2) The Licensing Authority may prescribe rules regulating the issue or otherwise of a marketing authorisation for immunological

Advertising of medicinal products.

Homeopathic medicinal products.

Products derived from human blood or human plasma.

Radiopharmace utical medicinal product.

Immunological medicinal products.

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Herbal medicinal products.

Manufacturer's licence.

Application for manufacturer's licence.

medicinal products.

36. (1) The provisions of this Part shall apply to herbal medicinal products other than herbal medicinal products prepared in accordance with a magistral or an official formula:

(2) The Licensing Authority may prescribe rules regulating the issue or otherwise of a marketing authorisation for herbal medicinal products.

Title II - Manufacture of Medicinal Products for Human Use

37. Without prejudice to any exemption that may be granted under this Act, no person shall manufacture, assemble or in any way modify any medicinal product except in accordance with a manufacturer's licence issued in accordance with the provisions of this Act or any regulations or rules made thereunder:

Provided that such a licence shall not be required for the preparation, division, changes in packaging or presentation where these processes are carried out for the purpose of dispensing or administering as provided under this Act.

38. (1) Any application for the grant of a licence to manufacture, assemble or modify a medicinal product shall be made to the Licensing Authority and shall contain such information, documents, samples and other material as provided by or under this Act:

Provided that such application shall indicate the following: (a) the name of the medicinal product and
pharmaceutical form or forms, which is to be manufactured,
assembled or in any way modified;
(b) the place where such activity is to take place, and such information and documentation as may be required in order to show that such place is suitable and sufficient for that purpose;
(c) the equipment and control facilities as may be required by or under this Act;
(d) the name and address of the applicant;
(e) the name of at least one qualified person who shall be professionally responsible for the activity, such person having such qualifications as may be prescribed:
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Provided that when more than one qualified person is nominated, the application will clearly delineate the specific responsibilities of each person;
(f) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with or under this Act.
(2) The Licensing Authority shall determine the application in the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant information is provided.

39. (1) The Licensing Authority shall, before determining an application, inspect the premises indicated in the application and shall not issue a licence until it is satisfied that such premises conform with the requirements established by or under this Act:

Provided that a licence may be made conditional to the carrying out of such obligations as may be imposed therein.
(2) The manufacturer's licence shall specify the premises and the medicinal products and pharmaceutical form or forms to which it applies.
(3) The licence holder shall ensure that the activity is carried out in accordance to the provisions of this Act and any regulations made thereunder.

40. Where the Licensing Authority considers that circumstances may exist which would render necessary the consideration of whether the licence should be varied, suspended or revoked, the Licensing Authority may serve on the holder of a manufacturer's licence a notice requiring him, within such time as may be specified in the notice, to furnish it with any information specified in the notice.

41. (1) The Licensing Authority may suspend a manufacturer's licence under this Act for such period as it may determine, or may revoke, or vary the provisions of, any such licence.

(2) The powers vested in subarticle (1) shall only be exercisable in any of the following circumstances, where:
(a) the matters stated in the application on which the licence was granted were false or incomplete in a material particular;

Granting of manufacturer's licence.

Notice for further information.

Suspension or revocation of manufacturer's licence.

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(b) a material change of circumstances has occurred in relation to any of those matters;
(c) any of the conditions of the licence has been contravened;
(d) the requirements in relation to the licences as established by or under this Act have not been complied with;
(e) the processes of manufacture or assembly of a medicinal product are carried out in a manner that is not in compliance with the provisions of the marketing authorisation of that medicinal product;
(f) the conditions for good manufacturing practice are not being complied with; and

Inspection in relation to manufacturers, etc.

Duration and renewal of manufacturer's licence.

(g) in any other circumstance as is established by or under this Act.

42. (1) The Licensing Authority shall carry out regular inspections to ensure that the requirements established by or under this Act in relation to the manufacture, assembly or modification of a medicinal product are complied with.

(2) The Licensing Authority or any person carrying out an inspection shall:
(a) inspect the manufacturing establishment and any other location he may deem necessary;
(b) examine any relevant documents;
(c) take any samples he may deem necessary;
(d) draw up a report of the findings and communicate the contents of such report to the licensee or the applicant for a licence in relation to such inspection and to the qualified person;
(e) carry out any other activity he may deem appropriate for the proper execution of his duties and responsibilities as provided for by or under this Act.
(3) Except in urgent cases an inspection shall be carried out in the presence of a qualified person or his representative, if any, .

43. (1) Subject to the provisions of this Act, every licence granted under this Part shall, unless previously renewed or revoked, expire at the end of its validity.

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(2) Any licence so granted shall, unless previously revoked, be renewable upon an application by the licensee made at least three months before the expiry of the validity period.
(3) The Licensing Authority may by rules establish the period of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the renewal of a licence under this Part, the Licensing Authority:
(a) may renew the licence, with or without modifications, for such a further period as specified; or
(b) if, having regard to the provisions of this Act, it considers it necessary or expedient to do so, may refuse to renew the licence.
(5) The provisions of articles 25, 39 and 40 shall apply to such applications.

44. It shall be the duty of the holder of a manufacturer's licence -

(a) to immediately inform the Licensing Authority of any change of the qualified person;
(b) to provide authorised officers access to his premises at any reasonable time;
(c) to enable the qualified person to carry out his duties established by or under this Act;
(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and have such records available for inspection by any authorised officer for such period of time as may be required by or under this Act;
(e) to have at his disposal the services of staff to satisfy the requirements specified by or under this Act in relation to the manufacture, assembly or modification of medicinal products;
(f) to apply in writing to the Licensing Authority of any change proposed or modification required in relation to the licence;
(g) to comply with the regulations or Orders relating to good practice in manufacture as may be established by or under

Responsibilities of manufacturer's licence holder.

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this Act or under any other Act;
(h) to dispose of medicinal products as established by or under this Act or under any other Act;

Responsibilities of the qualified person.

Suspension of activity of a qualified person.

Change in conditions of manufacturer's licence.

Obligations of Licensing Authority.

(i) other responsibilities as may be established from time to time by or under this Act.

45. (1) The responsibilities of a qualified person shall be:

(a) to ensure that standards of good practice in manufacturing are complied with at all times;
(b) to ensure that each batch of medicinal products has been manufactured, tested and complies in all respects with any requirement established by or under this Act; and
(c) to ensure that each batch of medicinal products has been manufactured in accordance with the requirements of the marketing authorisation.
(2) The qualified person shall at all times be present at the premises when the activity is being carried out:
Provided that the qualified persons may nominate another person similarly qualified to act as his representative.
(3) When the qualified person has nominated a representative as aforesaid he shall immediately inform the Licensing Authority of such nomination.

46. The Licensing Authority, may if it has reasonable suspicion to believe that any qualified person is acting in contravention of any of the provisions of this Act, suspend the activity of such qualified person by notice in writing specifying the reasons for such suspension until such person has complied with any requirement of the Licensing Authority to remedy the non- compliance.

47. The Licensing Authority may upon an application made by the holder of licence in request thereof, vary the conditions of the licence if it is satisfied that such variation will not adversely affect standards of good practice in manufacture as may be prescribed.

48. The Licensing Authority may vary, suspend, revoke or refuse to renew a manufacturer's licence, or it may refer the matter to the Medicines Authority, and in such case the provisions of article

20(4), (5) and (6) and of article 21 shall, mutatis mutandis apply.
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49. Without prejudice to article 32, the provisions of articles

37 to 48 shall apply to the manufacture and assembly of homeopathic medicinal products other than the products listed in article 32(a) (b) and (c).

50. Without prejudice to article 33, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the manufacture and assembly of medicinal products derived from human blood and human plasma other than the products listed in article 32(a) (b) and (c).

51. Without prejudice to article 34, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the manufacture and assembly of radiopharmaceutical medicinal products other than the products listed in article 32(a) (b) and (c).

52. Without prejudice to article 35, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the manufacture and assembly of immunological medicinal products other than the products listed in article 32(a) (b) and (c).

53. Without prejudice to article 36, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the manufacture and assembly of herbal medicinal products other than the products listed in article 32(a) (b) and (c).

Title III - Wholesale Distribution of Medicinal Products for Human Use

54. (1) Without prejudice to any exemptions that may be granted by or under this Act, no person shall engage in the wholesale distribution of any medicinal product unless he is the holder of a wholesale dealer's licence issued in accordance with the provisions of this Act. and unless the medicinal product has been granted a marketing authorisation by the Licensing Authority.

(2) The wholesale distribution of a medicinal product by way of wholesale dealing shall only be carried out from the place specified in, and in accordance with the conditions of, the licence.

55. (1) Any application for the grant of a wholesaler's licence shall be made to the Licensing Authority and shall contain such information, documents, and other material as provided by or under this Act:

Provided that such application shall indicate the following: (a) the name and address of the applicant;

Manufacture of homeopathic medicinal products.

Manufacture of medicinal products derived from human blood and

human plasma, etc.

Manufacture of radiopharma- ceuticals.

Immunological medicinal product.

Herbal medicinal products.

Wholesale dealing.

Application for a wholesale dealer's licence.

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(b) the address of the premises that are to be used for the purpose of wholesale distribution;
(c) the equipment and control facilities as may be required by or under this Act;
(d) information, documentation or evidence to prove that the premises is suitable and adequate, and that there are suitable facilities, installations and equipment so as to ensure proper conservation and distribution of medicinal products;
(e) the name of at least one responsible or qualified person who shall be professionally responsible for the activity, such person having such qualifications as may be prescribed:
Provided that when more than one qualified or responsible person is nominated, the application will clearly delineate the specific responsibilities of each person;
(f) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with or under this Act.
(2) The Licensing Authority shall determine the application in the period of time as may be established under this Act:

Granting of a wholesale dealer's licence.

Notice for further information.

Provided that such time may be suspended until the relevant information is provided.

56. (1) The Licensing Authority shall, before determining an application, inspect the premises indicated in the application and shall not issue a licence until it is satisfied that such premises conform with the requirements established by or under this Act:

Provided that a licence may be made conditional to the carrying out of such obligations as may be imposed therein.
(2) The wholesale dealer's licence shall specify the premises and the activities to which it applies.
(3) The licence holder shall ensure that the activity is carried out in accordance to the provisions of this Act and any regulations made thereunder.

57. Where the Licensing Authority considers that circumstances may exist which would render necessary the consideration of whether the licence should be varied, suspended or revoked, the Licensing Authority may serve on the holder of a

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wholesale dealer's licence a notice requiring him, within such time as may be specified in the notice, to furnish it with any information specified in the notice.

58. (1) Subject to the provisions of this Act, every licence granted under this Part shall, unless previously renewed or revoked, expire at the end of its validity.

(2) Any licence so granted shall, unless previously revoked, be renewable upon an application by the licensee made at least three months before the expiry of the validity period.
(3) The Licensing Authority may by rules establish the period of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the renewal of a licence under this Part, the Licensing Authority:
(a) may renew the licence, with or without modifications, for such a further period as specified; or
(b) if, having regard to the provisions of this Act, it considers it necessary or expedient to do so, may refuse to renew the licence.
(5) The provisions of articles 25, 39 and 40 shall apply to such applications.

59. It shall be the duty of the holder of a wholesale dealer's licence -

(a) to immediately inform the Licensing Authority of any change of the qualified or responsible person;
(b) to provide authorised officers access to his premises at any reasonable time;
(c) to enable the Licensing Authority to carry out its duties established by or under this Act;
(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and have such records available for inspection by any authorised officer for such period of time as may be required by or under this Act.

60. (1) The responsible person shall ensure that standards of good practice in wholesale distribution as may be prescribed are complied with at all times.

Duration and renewal of wholesale dealer's licence.

Obligations of holder of wholesale dealer's licence.

Responsibilities of the responsible person.

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(2) The qualified or responsible person shall at all times be present at the premises when the licenced activity is being carried out:
Provided that the qualified or responsible person may nominate another person to act as his representative.

Suspension or revocation of wholesale dealer's licence.

Change in conditions of a wholesale dealer's licence.

Obligations of Licensing Authority.

Inspecting in relation to wholesale.

(3) When the qualified or responsible person has nominated a representative as aforesaid he shall immediately inform the Licensing Authority of such nomination.

61. The Licensing Authority may suspend a wholesale dealers' licence granted under this Act for such period as it may determine, or may revoke, or vary the provisions of, any such licence in any of the following cases:

(a) where the matters stated in the application on which the licence was issued were false or incomplete in a material particular;
(b) where a material change of circumstances has occurred in relation to any of those matters;
(c) where any of the conditions of the licence has been contravened;
(d) where the requirements in relation to the licence as established by or under this Act have not been complied with;
(e) where conditions of good practice in wholesale distribution are not being complied with; and
(f) in any other circumstance as may be established by or under this Act.

62. The Licensing Authority may, upon an application made by the holder of a licence in respect thereof, vary the conditions of the licence, if it is satisfied that such variation will not adversely affect the standards of good practice in wholesale distribution.

63. The Licensing Authority may vary, suspend, revoke or refuse to renew a wholesale dealer's licence, or it may refer the matter to the Medicines Authority, and in such case the provisions of article

20(4), (5) and (6) and of article 21 shall, mutatis mutandis apply.

64. (1) The Licensing Authority shall ensure that the requirements established by or under this Act in relation to the wholesale dealing of a medicinal product are complied with.

(2) The Licensing Authority shall:
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(a) inspect the wholesale dealing establishment and any other location it may deem necessary;
(b) examine any documents relating to the inspection; (c) take any samples it may deem necessary;
(d) draw up a report of the findings, which shall be communicated to the licensee or the applicant for a licence in relation to such inspection and to the responsible person;
(e) carry out any other activity it may deem appropriate for the proper execution of its duties and responsibilities as provided for by or under this Act.

65. Without prejudice to the provisions of this Part, the Licensing Authority may by rules establish additional requirements for the wholesale distribution of:

(a) narcotic or psychotropic substances;
(b) medicinal products derived from blood; (c) immunological medicinal products;
(d) radiopharmaceuticals;
(e) such other medicinal products or class or classes of medicinal products as the Minister may prescribe.

Title IV - Pharmacies and Related Pharmaceutical Activity

66. (1) It shall not be lawful for any person to open or keep a pharmacy unless he is in possession of a pharmacy licence issued in accordance with the provisions of this Act or any regulations made thereunder.

(2) Licences are to be issued in accordance with geo- demographic criteria as may be established by regulations made under this Act.
(3) Regulations under this article shall not be made unless the Minister shall have first published a draft thereof in the Government Gazette allowing any person a period of at least four weeks to make representations to the Minister.
(4) The Minister shall request the Licensing Authority to report on any representation made to him after hearing such person or taking such expert advice as it considers expedient, together with any

Special provisions.

Licence to open a pharmacy.

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views it may have and the Minister may, upon receipt of the report by the Licensing Authority proceed to revise the draft regulations and to promulgate such regulations in accordance with such revision.
(5) Without prejudice to any exemption that may be granted by or under this Act, no person shall sell by retail any medicinal product expect in accordance with a pharmacy licence issued in accordance with the provisions of this Act or any regulations or rules made thereunder.

Application for a pharmacy licence.

Grant of a pharmacy licence.

(6) The licensee shall be responsible for complying with the conditions of the licence as may be established by or under this Act.

67. (1) Any application for the grant of a pharmacy licence shall be made to the Licensing Authority and shall contain such information, documents, samples and other material as provided by or under this Act:

Provided that such application shall indicate the following: (a) the name and address of the applicant;
(b) the address of the premises that are to be used for the purpose of the retail sale of the medicinal products;
(c) the equipment and control facilities as may be required by or under this Act;
(d) information, documentation or evidence to prove that the premises is suitable and adequate, and that there are suitable facilities, installations, and equipment so as to ensure proper conservation and dispensing of medicinal products;
(e) the name of a managing pharmacist who shall be professionally responsible for all activities;
(f) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with or under this Act.
(2) The Licensing Authority shall determine the application in the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant information is provided.

68. (1) The Licensing Authority shall, before determining an application, inspect the premises indicated in the application and

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shall not issue a licence until it is satisfied that such premises conform with the requirements established by or under this Act:
Provided that a licence may be made conditional to the carrying out of such obligations as may be imposed therein.
(2) The pharmacy licence shall specify the premises and the activities to which it applies:
Provided that the Licensing Authority may, upon application, grant an additional licence for the use of identified premises to be used as a store for the purpose of the pharmacy after it is satisfied that such premises comply with any requirements established by or under this Act.

69. Where the Licensing Authority considers that circumstances may exist which would render necessary the consideration of whether the licence should be varied, suspended or revoked, the Licensing Authority may serve on the holder of a pharmacy licence a notice requiring him, within such time as may be specified in the notice, to furnish it with any information specified in the notice.

70. (1) Subject to the provisions of this Act, every licence granted under this Part shall, unless previously renewed or revoked, expire at the end of its validity.

(2) Any licence so granted shall, unless previously revoked, be renewable upon an application by the licensee made at least three months before the expiry of the validity period.
(3) The Licensing Authority may by rules establish the period of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the renewal of a licence under this Part, the Licensing Authority:
(a) shall renew the licence, with or without modifications, for such a further period as specified; or
(b) if, having regard to the provisions of this Act, it considers it necessary or expedient to do so, may refuse to renew the licence.
(5) The provisions of articles 25 and 39 shall apply to such applications.

Notice for further information.

Duration and renewal of pharmacy licence.

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Transfer of a pharmacy licence.

Suspension or revocation of pharmacy licence.

Temporary closure of pharmacy.

71. No person may transfer a licence unless authorised by the Licensing Authority which authorisation shall not be issued unless the Licensing Authority is satisfied that the new licensee complies with any requirement established by or under this Act, and on payment of the prescribed fee.

72. The Licensing Authority may suspend a pharmacy licence granted under this Act for such period as it may determine or may revoke, or vary the provisions of any such licence in any of the following circumstances:

(a) where any matter stated in the application on which the licence was issued is false or incomplete
(b) where a material change of circumstances has occurred in relation to any of those matters;
(c) where the provisions of the licence have been contravened by the licensee; or
(d) in any other circumstance as may be established by or under this Act:
Provided that the Licensing Authority shall notify the licensee of the decision giving detailed reasons for such decision.

73. (1) The licensee of a pharmacy shall not close a pharmacy, temporarily or otherwise, unless he has given at least twenty-four hours notice to, and such closure has been authorised by, the Licensing Authority:

Provided that the temporary closure shall not be construed to include the closure of a pharmacy resulting from the unforeseen or unexpected absence of a pharmacist, force majeure resulting in the inability to open the premises, or closure outside the business hours established for pharmacies by rules made the Licensing Authority.
(2) Subject to the provisions of subarticle (1), the licence in relation to a pharmacy which has remained closed for a period of five consecutive working days without the authorisation of the Licensing Authority shall be deemed to have been automatically revoked.
(3) The Licensing Authority may, on receipt of a notice as is referred to in subarticle (1), or where it has come to its knowledge that a pharmacy has been closed, seal all the medicinal products, wherever kept by the licensee in terms of the provisions of this Act, and take charge of any register required to be kept by the licensee under this or any other law.
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74. It shall be the duty of the holder of a pharmacy licence -

(a) to inform the Licensing Authority of any change of the managing pharmacist, prior to such change;
(b) to provide authorised officers access to his premises at any reasonable time;
(c) to enable the Licensing Authority to carry out its duties established by or under this Act;
(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and have such records available for inspection by any authorised officer for such period of time as may be required by or under this Act;
(e) to comply with regulations or Orders relating to good practice in retail sale of medicinal products as may be established by or under this Act;
(f) to dispose of medicinal products as established by or under this Act or any other law;
(g) other responsibilities as may be established from time to time by or under this Act.

75. (1) Every pharmacy shall be managed by a pharmacist hereinafter referred to as the "managing pharmacist".

(2) The managing pharmacist shall:
(a) act as the managing pharmacist of a licensed pharmacy including any other premises used as a store by the said pharmacy in terms of article 68(2);
(b) ensure that he or another pharmacist sells or supervises the sale of medicinal products present in the pharmacy and keep records of the pharmacist who was present at all times while the pharmacy was open;
(c) keep any documents, information or evidence in the manner as may be required to be kept by or under this Act;
(d) carry out such obligations pertaining to a managing pharmacist as may be established by or under this Act;
(e) nominate a substitute managing pharmacist when he cannot carry out his duties for a period of five or more

Obligations of the holder of a pharmacy licence.

Managing pharmacist.

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consecutive days and shall notify the Licensing Authority of this substitution:
Provided that in exceptional cases the licensee may nominate a replacement and notify the Licensing Authority;
(f) comply with regulations or rules relating to good practice in the dispensing of medicinal products as may be established by or under this Act;
(g) dispose of medicinal products as established by or under this Act or any other law.
(3) No pharmacist may, without the authority in writing of the Licensing Authority, act as a managing pharmacist of two or more pharmacies:
Provided that the Licensing Authority shall not give such authority unless it is satisfied that such pharmacist can reasonably carry out the duties of a managing pharmacist for more than one pharmacy.

Duties of pharmacist.

Interest in a pharmacy.

Licensee may employ one or more pharmacists.

(4) No pharmacist shall take up or abandon his duties as a managing pharmacist of any pharmacy without giving prior notice in writing to that effect to the Licensing Authority.

76. (1) Unless otherwise provided by or under this Act, a medicinal product shall only be prepared or dispensed from a pharmacy and by a pharmasist:

Provided that a pharmacist may permit medicinal products to be prepared or dispensed by a pharmacy technician under his personal supervision as regulated by or under this Act.
(2) In carrying out his functions in the preparation and dispensing of medicinal products from a pharmacy, a pharmacist shall act in accordance with such standards as may be established by or under this Act or any other Act.

77. The conditions and criteria where any person can have or not have a direct or indirect interest in a pharmacy are to be defined in the Third Schedule to this Act.

78. The licensee shall employ a pharmacist to carry out the responsibilities of a managing pharmacist and shall provide all the support and in no way interfere with the managing pharmacist's or a pharmacist's professional responsibilities in the performance of his duties as defined in by or under this Act or under any other law.

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79. (1) A pharmacy shall only dispense in medicinal products and trade in products or groups or classes of products that may from time to time be established by rules made by the Licensing Authority.

(2) Unless otherwise provided by or under this Act, a medicinal product shall only be sold from a pharmacy:
Provided that the Licensing Authority may, in special circumstances relating to the provision of services to the public, by rules prescribe that a medicinal product or class or classes of medicinal products therein specified may be sold from a premises other than a pharmacy such premises not being a general retail outlet:
Provided further that the Licensing Authority may with same circumstances by rules prescribe that a medicinal product of class or classes of medicinal products therein specified may be sold, prepared or provided to a patient by a person, other than a pharmacist, who is suitably qualified for such purpose:
Provided also that such rules shall provide for the circumstances under which such a sale, preparation or provision may occur and impose such restrictions as may be provided.
(3) The Licensing Authority may by rules establish a list of medicinal products that as a minimum must be available at a pharmacy at all times:
Provided that this requirement may be temporarily waived in relation to a particular medicinal product or class of medicinal product in exceptional circumstances, if the Licensing Authority is satisfied that the unavailability of such a medicinal product or class of medicinal product from a pharmacy is beyond the control of the managing pharmacist.

80. (1) A pharmacist shall prepare or dispense any medicinal product required by any person presenting a prescription unless he has a justified reason of concern that the prescription is false, that the person is misusing the prescribed medicinal product, or that the medicinal product is not available or if he has professional reasons for not preparing or dispensing the prescription.

(2) Upon presentation of a prescription for a medicinal product, unless the prescriber specifically requests a particular branded product by writing "branded" or "®" on the prescription, a pharmacist can dispense the medicinal product prescribed or an equivalent medicinal product having the same chemical entity, dose, dosage form, formulation and dosage frequency as the medicinal

Medicinal products to be sold from a pharmacy.

Dispensing of a medicinal product.

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product indicated on the prescription.
(3) When, in dispensing any medicinal product, a pharmacist discovers that there are reasons why the medicinal product should not be dispensed to the patient or that the dosage regimen indicated on the prescription goes beyond what can be considered a safe therapeutic dose, the pharmacist is bound to draw the attention thereto of the person prescribing the same and may require such person to write out in ink or in other indelible manner on the prescription a statement assuming responsibility for the prescription.

Dispensing against prescription.

Presentation of a prescription.

Labelling of dispensed products.

Disposal of expired, deteriorated or imperfect products.

(4) The pharmacist shall assume full responsibility for the dispensing of medicinal products which do not need a prescription for dispensing to patients.

81. (1) It shall not be lawful for any pharmacist to dispense any medicinal product except on the prescription of a medical or dental practitioner, veterinary surgeon or other person authorized to prescribe under this or any other Act, unless the medicinal product is deemed not to require a medicinal prescription by the Licensing Authority.

(2) The provisions of subarticle (1) shall also apply to products or substances not classified as medicinal products but which have been deemed to require a medicinal prescription for their use by the relevant competent authority.

82. The Licensing Authority may by rules prescribe the format, content and presentation of a prescription required by or under this Act.

83. The pharmacist shall label each medicinal product or magistral formula or official formula dispensed in accordance with such regulations or rules made under this Act.

84. It shall not be lawful for any managing pharmacist to sell, allow the sale, dispensing or supply in any other way of -

(a) any imperfect, deteriorated or harmful substance;
(b) any medicinal product bearing an expiry date which has expired;
(c) food not in accordance with the provisions of the
Food Safety Act, 2002, or any regulations made thereunder:
Provided that such imperfect, deteriorated or expired substances or medicinal products shall only be kept in such place and
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in such a manner as the Licensing Authority may from time to time by rules establish.

85. (1) It shall not be lawful for any managing pharmacist to keep anywhere within the pharmacy any medicinal product in any container or under such conditions which are not suitable to the nature thereof and which are not such as to protect it from alteration, deterioration or contamination.

(2) It shall not be lawful for any managing pharmacist to permit any medicinal product under his charge to be kept or stored outside the pharmacy under his management, and it shall be his duty to ensure that the pharmacy has the facilities to ensure that medicinal products are stored in accordance with storage recommendations:
Provided that in the case where the Licensing Authority has granted a licence for the keeping or storage of medicinal products in any premises other than the pharmacy, the responsibilities of the managing pharmacist shall also apply to such premises.

86. Premises, facilities, records and equipment used for the storage, preparation and dispensing of medicinal products are to be kept in accordance with the requirements and standards established by or under this Act.

87. The preparation of magistral and official formulas, and the pre-packing, reconstitution, dispensing and administration of medicinal products and any other activity related to medicinal products and their use shall be in accordance with such standards as may be established under this Act.

88. (1) The Licensing Authority shall have the right to inspect pharmacies and any premises licensed for use as stores under article 68(2) whenever it deems necessary.

(2) Any inspection as aforesaid shall be carried out in the presence of the managing pharmacist or of the pharmacist for the time being in charge of the pharmacy.
(3) At the time of the inspection, the inspecting officer shall draw up a list of deficiencies that may have been identified at the time of the inspection and shall sign this list, and such list shall be countersigned by the managing pharmacist or by the pharmacist for the time being in charge of the pharmacy:
Provided that the inspecting officer shall draw up a report of the inspection within seven working days of the inspection and shall forward a copy of such report to the Licensing Authority, the

Storage of medicinal products in pharmacy.

Premises, etc., in accordance with requirements and standards.

Pharmacist to be guided by set standards.

Inspections of pharmacies.

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licensee and the managing pharmacist:
Provided also that the managing pharmacist or pharmacist for the time being in charge of the pharmacy may make comments or otherwise make reservations in respect of the contents of the said list.
(4) (a) If in the course of the inspection, any article is found to be in breach of the provisions of this Act or any regulation made thereunder, the inspecting officer shall forthwith seize the said article.
(b) The wrapper or receptacle containing the article so seized shall be sealed and the signature of the inspecting officer and the managing pharmacist shall be appended to the seal:
Provided that if the managing pharmacist so requests, the article in question shall be divided, by the inspecting officer, in two equal parts, sealed and signed in the manner as aforesaid, and one part be given to the managing pharmacist:
Provided further that the inspecting officer shall send the seized article, sealed and signed in the manner aforesaid to the Licensing Authority together with the inspection report as described in subarticle (3).

Opening of pharmacies.

Definition of poisons.

(5) If the managing pharmacist or the pharmacist for the time being in charge of the pharmacy refuses to countersign the list referred to in subarticle (3), the inspecting officer shall record such fact on the said list together with the reason given, if any, for such refusal.

89. The Licensing Authority may by notice in the Gazette establish the business hours of pharmacies and may also require pharmacies in specified localities or districts to open for the serving of customers on such days and for such times as may be specified in such notice.

PART IV

POISONOUS SUBSTANCES

90. For the purposes of the provisions contained in this Part, "poison" means -

(a) all those substances which, taken even in a very small dose, may cause the death or serious injury to any person,
(b) all those substances which the Minister may, on the advice of the Licensing Authority, prescribe,
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but does not include any similar substance which is used, or is intended to be used, for day to day domestic purposes, which latter substance, however shall be deemed to be a poison for the purpose of article 94.

91. It shall not be lawful for any person to keep for sale, manufacture, sell or otherwise distribute or deal in any poison without a licence from the Licensing Authority .

92. (1) The licence mentioned in article 91 shall only be granted to manufacturers of, and dealers in chemical products, colorists and such other persons as require to make use of poisons in the exercise of their trade or profession.

(2) Such licence shall show the name and surname of the licensee, his trade or profession, and the place in which he intends to carry on such trade or profession and any other information as may be established from time to time by rules made by the Licensing Authority.

93. Every person granted a licence under article 91 shall keep all poisonous substances in a separate and safe place the key whereof shall be always kept by the licence holder.

94. (1) No person granted a licence under article 91 shall sell or deliver any poisonous substance, either by wholesale or retail, to any person not being a pharmacist, except on production of a prescription or for purposes of disinfection or industry or for any other purpose as may be authorised by the Licensing Authority.

(2) Every person granted a licence under article 91 shall keep, maintain, update, store and make available to the Licensing Authority or any authorised person any information as may from time to time be required by the Licensing Authority and in any such manner as may be form time to time be required by the Licensing Authority.
(3) Poisonous substances shall be labelled in such a manner the Licensing Authority may from time to time by rules establish.

95. The Licensing Authority or any authorised officer, may in the interest of public health, pay surprise visits to the business premises of manufacturers of and dealers in chemical products and of the other persons referred to in article 91.

96. Without prejudice to the provisions of the Pesticides Control Act, it is prohibited to sow, cast, put or place, or cause to be sown, cast, put or placed in or upon any land or other exposed place any grain, seed, meal, or flesh which has been so dipped or steeped in

Keeping, etc., of poisons.

Licence for sale of poisons.

Keeping of poisonous substances in a safe place.

Sale of poisonous substances.

Power of inspection.

Poisoned grain, seed etc.,

Cap. 430.

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poison, or has been so mixed with poison or other ingredient or preparation as to be rendered poisonous and calculated to destroy life.

PART V

Special restrictions on persons to be supplied with medicinal products.

Adulteration of medicinal products.

Offences and penalties.

OTHER DEALINGS WITH MEDICINAL PRODUCTS

97. The Licensing Authority may by rules provide, either in respect of medicinal products generally or in respect of medicinal products of a description or falling within a class specified in the rules that, subject to such exceptions as may be so specified, no person -

(a) being the holder of a marketing authorisation, or
(b) in the course of business carried by him and consisting, in whole or in part, of manufacturing medicinal products or of selling medicinal products by way of wholesale dealing,
shall sell or supply any medicinal product to which the rules apply to any person who does not fall within a class specified in those rules.

98. No person shall -

(a) add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition of the product, with the intent that the product shall be sold or supplied in that state; or
(b) sell or supply, or offer or expose for sale or supply, or have in his possession for the purpose of sale or supply, any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.

PART VI

OFFENCES AND PENALTIES

99. (1) Without prejudice to any other liability under any other law, any person who fails to comply with any of the provisions of this Act or any regulations or rules made thereunder shall be guilty of an offence and shall, on conviction, be liable, in the case of an offence against:

(a) the provisions of articles 20, 24, 28, 37, 39, 41 and
43, to a fine (multa ) of not less than ten thousand liri and not exceeding fifty thousand liri or to imprisonment for a term not exceeding two years, or both such fine and imprisonment;
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(b) the provisions of articles 54, 56, 58 and 61, to a fine (multa) of not less than five thousand liri and not exceeding thirty thousand liri or to imprisonment for a term not exceeding six months, or both such fine and imprisonment;
(c) the provisions of articles 44, 45, 66(1), 71, 75(3),
75(4), 76(1), 81(1), 91 and 98, to a fine (multa) of not less than two thousand liri and not exceeding twenty thousand liri or to imprisonment for a term not exceeding three months, or to both such fine and imprisonment;
(d) the provisions of articles 59, 60, 65, 74(b), 75(1),
75(2), 84, 93, 94(1) and 96, to a fine (multa) of not less than five hundred liri and not exceeding ten thousand liri;
(e) the provisions of articles 31, 66(2), 78, 85(1), 85(2) and 94(2), to a fine (multa) of not less than two hundred liri and not exceeding five thousand liri;
(f) the provisions of articles 29, 73(1) and 94(3), to a fine (multa) of not less than one hundred liri and not exceeding one thousand liri.
(2) Without prejudice to the powers of the Licensing Authority under this Act, where any person who has committed an offence is the holder of a licence or an authorisation under this Act, and the conviction is the third or subsequent conviction, the Court shall, at the request of the prosecution, order the revocation or suspension of the aforesaid licence or authorisation.

100. (1) Notwithstanding any other law providing for the trial of offences, where the Licensing Authority believes that a person has committed an offence against this Act or any regulations or rules made thereunder, the Authority shall give notice in writing to such person describing the offence of which the person is accused, indicating the steps to be taken to remedy the offence and the penalty which he is required to pay in respect of that offence.

(2) The Minister shall prescribe the penalties that may be demanded by the Licensing Authority in relation to any specified offence:
Provided that such penalty shall not exceed an amount of ten thousand liri.
(3) Where a notice under this article has been given, the person named in the notice may, within twenty-one days of the service of the notice, accept responsibility for the offence specified in

Special procedure.

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Cap. 9.

the notice and within the same period pay the penalty indicated in the notice, and comply with the relative provision of this Act, or of the regulations or rules made thereunder and no further proceedings may be taken under this Act in respect of such offence.
(4) Where the person to whom notice is given under subarticle (1) has not paid the penalty within the twenty-one day period referred to in subarticle (3) and has not, within the time specified, complied with the requirements of this Act, criminal proceedings may be taken against him in accordance with the provisions of the Criminal Code, of this Act and of any other law applicable of the offence.

PART VII

ENFORCEMENT

Right of entry. 101. (1) Subject to the provisions of this article, and without prejudice to the other provisions of this Act, any person duly authorised in writing by the Licensing Authority shall, on production of his authorisation or credentials, have a right at any reasonable time to enter any premises:

(a) for the purpose of ascertaining whether there is or has been, or there is likely to be any contravention of any provisions of this Act or of any regulations or rules made thereunder;
(b) generally for the purposes of the exercise by the Licensing Authority of its function under this Act or under any regulations or rules made thereunder.
For the purposes of this Part, premises shall include any building, structure, any other place whatsoever or any means of transport.

Power to inspect, take samples and seize goods and documents.

(2) Any authorised officer shall, on the production of his authorisation, have a right at any reasonable time to board any ship or aircraft for the purpose of ascertaining whether there is in the ship or aircraft any substance or article imported in contravention of any provisions of this Act or of any regulations or rules made thereunder or whether the said craft is carrying out any activity in contravention to any of the said provisions.

102. (1) For the purpose of ascertaining whether there is or has been or there is likely to be a contravention of this Act or of any regulations or rules made thereunder, an authorised officer shall have a right to inspect:

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(a) any substance or article appearing to him to be a medicinal product;
(b) any article used or intended to be used to contain any medicinal product or to be a label or leaflet used or intended to be used in connection with a medicinal product; or
(c) any plant or equipment appearing to him to be used or intended to be used in connection with the manufacture or assembly of medicinal products, and any process of manufacture or assembly of any medicinal products and the means employed, at any stage in the process of manufacture or assembly, for testing the materials after they have been subjected to those processes.
(2) An authorised officer may, for the purpose specified in the preceding subarticle, take a sample of any:
(a) substance or medicinal product sold or supplied or intended to be sold or supplied; or
(b) substance or article used or intended to be used in the manufacture of a medicinal product.
(3) For the purposes of subarticle (1), an authorised person shall have the right:
(a) to inspect any records, in whatever form they are held, related to the manufacture, assembly, sale or supply of a medicinal product and, where such records are kept in electronic form:
(i) may have access to, and inspect and check the operation of any computer, any associated apparatus or material which is or has been in use in connection with the records; and
(ii) may require any person having charge of, or otherwise connected with the operation of, the computer, apparatus or material to afford him such assistance as he may reasonably require;
(b) to take copies of any entry in any book or document produced in pursuance of the preceding paragraph and where the records are kept electronically, by means of a computer or otherwise, require the records to be produced in an intelligible form which may be taken away.
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(4) Any authorised officer shall have a right to seize, remove and detain any substance or article which he has reasonable cause to believe to be a substance or article in relation to which, or by means of which, an offence under this Act is being or has been committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under this Act.
(5) For the purpose of subarticle (4), any authorised person may, so far as is reasonably necessary in order to secure compliance with the provisions of this Act and any regulations or rules made thereunder, require any person to break open any container, package or machine, or to permit him to do so:
Provided that where a person seizes any substance or article, including any document, for the purposes specified in subarticle (4), he shall inform the person from whom it is seized and give him a receipt thereof.
(6) Without prejudice to the preceding provisions of this article, any authorised person shall have the same rights conferred by those provisions in relation to things belonging to, or any business carried on by, an applicant for an authorisation or certificate under Part III of this Act, and may exercise such rights for the purpose of verifying any statements or information contained in the application for the authorisation or certificate; and, where by virtue of the provisions of this subarticle a person exercises any such right as is specified in subarticle (4), he shall be subject to the duty imposed by subarticle (5).

Application of sampling procedure to substance or article seized.

(7) Notwithstanding anything in the preceding provisions of this article, where a person claiming to exercise a right by virtue of the provisions of this article is required to produce his authorisation or credentials, the right shall only be exercisable by him on the production of the authorisation or credentials.

103. (1) The provisions of this article shall apply where an authorised officer seizes a substance or article, other than a document, in the exercise of such a right as is specified in article 102(4) and (6).

(2) If any person who in accordance with article 102(5) is entitled to be informed of the seizure so requests, either at the time of the seizure or at any subsequent time, not being later than twenty-one days after he is informed of the seizure, then subject to the following provisions of this article, the authorised officer shall either:
(a) set aside a sample of the substance or article seized;
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or
(b) treat that substance or article as a sample,
whichever he considers more appropriate having regard to the nature of that substance or article.
(3) An authorised officer shall not be required by virtue of subarticle (2) to set aside a sample, or to treat a substance or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those things.
(4) Where in accordance with subarticle (2) an authorised officer sets aside a sample, or treat a substance or article as a sample, he shall divide it into three parts, each part to be marked and sealed or fastened up in such manner as its nature will permit, and shall supply one excerpt of it to the person who made the request under subarticle (2).

104. (1) Any person entering any property or any other premises, ship, aircraft, stall or place in accordance with the provisions of article 101, may be accompanied by such other person or take such equipment as may appear to him to be necessary; and on leaving any such property shall, if the property is unoccupied or the occupier or any other person who is in charge of a ship, aircraft, vehicle, stall or place, is temporarily absent, leave it as effectively secured.

(2) The authorised officer shall also have such other powers as may be prescribed by regulations made by the Minister for the proper execution of his functions.

PART VIII

MISCELLANEOUS PROVISIONS

105. (1) For the purposes of this Act, the Minister may, on the advice of the Licensing Authority, by regulations prescribe that a provision or provisions in relation to the marketing authorisation of a medicinal product shall be deemed to be satisfied, if the standards of manufacture, medicinal product quality, safety or efficacy, or the provisions in relation to the granting of a marketing authorisation of a country designated in such regulations, are satisfied.

106. The Minister may, after consultation with the Licensing Authority, amend the schedules to this Act, prescribe by regulations anything that may be prescribed under this Act and make provision on any matter relating to medicinal products, poisons and pharmacies in

Supplementary provisions as to right of entry.

Recognition of equivalent standards.

Power of Minister to make regulations.

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order to give fuller effect to the provisions of this Act, and, in particular, but without prejudice to the generality of the aforesaid, shall by such regulations regulate or otherwise provide for:
(a) the grant of marketing authorisations;
(b) the manufacture of medicinal products and raw materials used in such manufacture;
(c) the wholesale distribution of medicinal products; (d) the sale and supply of medicinal products;
(e) the licensing of pharmacies;
(f) the reporting of adverse drug reactions;
(g) advertising in respect of medicinal products, and the presentation and information contained in the advert:
Provided that the advertising of certain medicinal products or classes of medicinal products may, by such regulations, be prohibited;
(h) the conduct of clinical trials;
(i) the classification of medicinal products; (j) the testing of medicinal products;
(k) the regulation of homeopathic medicinal products; radiopharmaceuticals and medicinal products derived from human blood and human plasma; immunological products, and herbal products;
(l) the roles and responsibilities of a licence or authorisation holder;
(m) the roles and responsibilities of the managing pharmacist, responsible person and qualified person;
(n) standards of good practice in the manufacture, wholesale, distribution and dispensing of medicinal products:
Provided that in the case of dispensing the Minister may take the opinion of the Pharmacy Board;
(o) the recognition of equivalent standards for medicinal product quality and efficacy in relation to such
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countries as may be prescribed;
(p) the recognition of equivalent standards for good practice in manufacture in relation to such countries as may be prescribed;
(q) the fees that may be levied by the Licensing
Authority and the Medicines Authority;
(r) exceptions to any provision in the interest of public health.

107. Any medicinal products on the market on the date of the coming into force of article 20 shall only be subject to the provisions of that article at such time and subject to such conditions as may by rules be established by the Licensing Authority.

108. Articles 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34,

35, 36, 37, 38, 39, 41, 42, 48, 88, 89, 92, 93 and 95 of the Medical and
Kindred Professions Ordinance shall be deleted.

109. (1) Any regulations made under the provisions of the articles, of the Medical and Kindred Professions Ordinance, which are being repealed by article 108, shall, until provision is made under or by virtue of this Act, continue in force and have effect as if made under this Act.

(2) Any licence, permission or other authorisation granted under any provision of the repealed articles as aforesaid, shall continue in force thereafter as if it were a licence, permission or authorisation granted under a corresponding provision or authority granted under this Act and shall be treated and dealt with accordingly.
(3) Any action taken or proceedings commenced against or in relation to any person under the repealed articles as aforesaid shall continue to have effect as if it were action or proceedings taken or commenced under a corresponding provision of this Act.

Transitory provision.

Amendment of Medical and Kindred Professions Ordinance, Cap.

31.

Saving.

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FIRST SCHEDULE
Areas of competency.
Anaesthesiology Analytical Chemistry Anatomy Biochemistry
Biotechnology Products Blood Products Cardiology Cosmiceuticals Dentistry
Dermatology Diabetes Endocrinology ENT Medicine Epidemiology Family Medicine Gastroenterology Genetics Geriatrics Haematology Herbals Homeopathics Immunology Intensive care
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Internal Medicine Medical Devices Medical Statistics
Microbiology (such as Virology, Bacteriology) Molecular Biology
Neurology Nephrology Nutraceuticals Nutrition
Obstetrics & Gynaecology
Oncology Ophthalmology Orthopaedics Paediatrics Pathology
Pharmaceutical Chemistry Pharmaceutical Technology Pharmacognosy Pharmacology
Physiology Psychiatry Radiology
Radiopharmaceuticals Respiratory Medicine Rheumatology
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Surgery Toxicology Transfusion Medicine Urology
Vaccines
SECOND SCHEDULE Proceedings of the Medicines Review Board
1. All members of the Medicines Review Board shall be present for a hearing of an appeal or the development of a second opinion.
2. All members of the Board shall have a vote and the opinion of the Board shall reflect the opinion of the majority of members:
Provided that a dissenting member may also request that his opinion be attached to the Board's opinion report as a minority report.
3. The appellant shall appear before the Board either in person or through an agent on the day and at the time fixed for the hearing, make his submissions and produce such evidence as the Board may allow:
Provided that the Board may postpone the hearing of the appeal if it is satisfied that the appellant was prevented from appearing before it owing to illness or absence from Malta or other similar reasonable cause.
4. The Board shall give the Medicines Authority an opportunity to make its submissions in justification of its opinion/s, and bring such evidence as the Board may consider necessary.
5. The Board shall have the power to summon witnesses and to administer the oath to any person appearing before it.
6. The Board shall have power to confirm or issue a different opinion to that appealed against, as it may deem appropriate.
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7. The opinion of the Board shall be final albeit not binding to the decision of the Licensing Authority and no appeal shall lie therefrom except on a question of law only.
8. Subject to the foregoing provisions and to the provisions of this Act, the Board shall regulate its own procedure.
THIRD SCHEDULE
Conditions and criteria where any person can have or not have a direct or indirect interest in a pharmacy
(1) No person shall qualify for a licence if he is a medical practitioner, dental surgeon, dentist or veterinary surgeon or if he is the husband or wife of any such medical practitioner, dental surgeon, dentist or veterinary surgeon.
(2) No licence shall be granted or renewed if a medical practitioner, dental surgeon, dentist or veterinary surgeon has any direct or indirect interest in a pharmacy.
(3) It shall not be lawful for any medical practitioner, dental surgeon, dentist or veterinary surgeon or any other person authorised to issue prescriptions under the Medicines Act or any other Act, to enter into any agreement with any pharmacist or any other person for any share in the profits of a pharmacy, or to have any direct or indirect interest of whatever nature in any pharmacy.
(4) It shall not be lawful for any pharmacist:
(a) to carry on the business of a pharmacy on account of, or in partnership with any medical practitioner, dental surgeon, dentist or veterinary surgeon or any other person authorised to issue prescriptions under the Medicines Act or any other Act;
(b) to enter into any agreement with any medical practitioner, dental surgeon, dentist or veterinary surgeon or any other person authorised to issue prescriptions as aforesaid, for any share in the profits of a pharmacy;
(c) to lend his name in order that the business may be carried out by some other person.
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Passed by the House of Representatives at Sitting No. 875 of the
25th February, 2003.
ANTON TABONE

Speaker

RICHARD J. CAUCHI

Clerk to the House of Representatives

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni — 3, Pjazza Kastilja — Published by the Department of Information — 3, Castille Place

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

Prezz Lm1.28c – Price 1.28c