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The Medicines (Amendment) Act, 2007 (Bill No. 95)

A Bill entitled

AN ACT to amend the Medicines Act, Cap. 458

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 (Amendment) Act, 2007.
(2) This Act shall be read and construed as one with the
Medicines Act, hereinafter referred to as “the principal Act”.
2. Article 2 of the principal Act shall be amended as follows> (a) immediately before the definition “advertising” there
shall be inserted the following new definition>-
“ “adverse reaction” means a response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function<”<
(b) immediately after the definition “clinical trial”, there shall be added the following new definition>-

Short title.

Amendment of article

2 of the principal

Act.

C 182
“ “common name” means the international non- proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name<”<
(c) for the definition “herbal medicinal product” there shall be substituted the following>-
““herbal medicinal product” means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations<”<
(d) for the definition “herbal preparations” there shall be substituted the following>-
“ “herbal preparations” means preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates<”<
(e) for the definition “herbal substances” there shall be substituted the following>-
“ “herbal substances” means all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author)<”<
(f) in the definition “homeopathic medicinal product”, for the words “in Malta” there shall be substituted the words “in the Member States”<
(g) for the definition “immunological medicinal product”
there shall be substituted the following>-
“immunological medicinal product” means any medicinal product consisting of vaccines, toxins, serums or allergen products, where –
(a) vaccines, toxins and serums shall cover in particular>
(i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine<
(ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin<
(iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti- smallpox globulin, antilymphocytic globulin<
(b) ‘allergen product’ shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent<”<
(h) in the definition “magistral formula” for the words “with a prescription” there shall be substituted the words “with a medical prescription”<
(i) in the definition “medicinal prescription” for the words “any prescription” there shall be substituted the words “any medicinal prescription”<
(j) for the definition “medicinal product” there shall be substituted the following>-
“ “medicinal product” means any substance or combination of substances -
(a) presented as having properties for treating or preventing disease in human beings< or
(b) which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis<”<
(k) immediately after the definition “medicinal product”, there shall be added the following new definition>-
C 183
C 184
“ “medicinal products derived from human blood or human plasma” means medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin<”<
(l) immediately after the definition “Minister” there shall be added the following new definition>-
“ “name of the medicinal product” means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder<”<
(m) the definitions “official formula” and “pre-packaging”
shall be deleted<
(n) immediately after the new definition “name of the medicinal product” there shall be inserted the following new definition>-
“ “officinal formula” means any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by such pharmacy<”<
(o) in the definition “radionuclide generator” for the word
“removed” there shall be substituted the word “obtained”<
(p) in the definition “radionuclide kit” for the words “radionuclide kit” there shall be substituted the word “kit”, and the said definition “kit” shall now be inserted immediately after the definition “investigational medicinal product”<
(q) in the definition “radionuclide precursor”, for the words
“radionuclide kit” there shall be substituted the words “kit”<
(r) for the definition “radiopharmaceutical” there shall be substituted the following>-
“ “radiopharmaceutical” means any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose<”<
(s) immediately after the definition “responsible person”
there shall be added the following new definition>-
“ “risk-benefit balance” means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in paragraph (a) of the definition”“risks related to use of the medicinal product<”<
(t) immediately after the definition “risk-benefit balance”
there shall be added the following new definition>-
“ “risks related to use of the medicinal product” means>- (a) any risk relating to the quality, safety or
efficacy of the medicinal product as regards patients’
health or public health<
(b) any risk of undesirable effects on the environment< ”<
(u) immediately after the definition “rules” there shall be added the following new definition>-
“ “serious adverse reaction” means an adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect”<
(v) immediately after the definition “serious adverse reaction” there shall be added the following new definition>-
“ “strength of the medicinal product” means the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form<”<
(w) for the definition “substance” there shall be substituted the following>-
“ “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, toxins, extracts, blood products), vegetable (including micro-organisms, plants, parts of plants, vegetable secretions, extracts), or chemical
C 185
C 186

Amendment of article 3 of

the principal Act.

(including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis)<”<
(x) immediately after the definition “Superintendent of
Public Health” there shall be inserted the following new definition>-
“ “unexpected adverse reaction” means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics<”
(y) for the definition “wholesale distribution” there shall be substituted the following>-
“ “wholesale distribution”, in relation to a medicinal product, includes all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in Malta.”<
(z) in the Maltese text only thereof>
(i) the definition “leaflets ;o pakkett” shall be deleted< (ii) immediately after the definition “farmakopeia
rikonoxxuta” there shall be added the following new
definition>-
“ “fuljett ta’ tag[rif” tfisser il-fuljett li jkun fih l- informazzjoni kollha g[al min ikun se juzah u li jkun jinsab flimkien mal-prodott mediçinali<”
(iii) in the definition “reklamar”, and in article 28(3), for the words “leaflets” and “leaflets ;o pakkett” wherever they occur there shall be substituted the words “fuljetti ta’ tag[rif” and “fuljett ta’ tag[rif” respectively< and
(iv) in article 102 (1)(b), for the word “leaflet” there shall be substituted the word “fuljett”.
3. For sub-article (3) of article 3 of the principal Act, there shall be substituted the following>
“(3) The Licensing Authority may by rules delegate any of its functions referred to in paragraphs (l), (m), (n) and (o) of sub- article (2) hereof to the Medicines Authority.”.
4. In sub-article (2) of article 10 of the principal Act, for the word “agency”, wherever it occurs, there shall be substituted the word “Authority”.
5. For paragraph (a) of sub-article (1) of article 16 of the principal
Act, there shall be substituted the following>-
“(a) to hear an appeal submitted by the applicant of a marketing authorisation on any recommendation of the Medicines Authority in relation to the safety, quality and efficacy of a medicinal product”.
6. For article 19 of the principal Act, there shall be substituted the following>
“19. (1) The provisions of Titles I, II and III shall apply> (a) to medicinal products for human use intended to
be placed on the market in Member States and either prepared
industrially or manufactured by a method involving an industrial process<
(b) in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a medicinal product and within the definition of a product covered by other Community legislation.
(2) Titles I, II and III of this Act shall not apply to – (a) any medicinal product prepared in accordance with
a magistral formula<
(b) any medicinal product prepared in accordance with an officinal formula<
(c) medicinal products intended for research and development trials, but without prejudice to the provisions of the Clinical Trials Regulations, 2004<
(d) radionuclides in the form of sealed sources<
C 187

Amendment of article 10 principal Act.

Amendment of article 16 of the principal Act.

Substitution of article 19 of the principal Act.

C 188

Amendment to Title I of Part III of the principal Act.

Amendment of article 28 of the principal Act.

(e) whole blood, plasma or blood cells of human origin, except for plasma prepared by a method involving an industrial process<
(f) intermediate products intended for further processing by an authorised manufacturer.
(3) (a) The Authority may, in accordance with legislation in force and to fulfill special needs, exclude from the provisions of this Act medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.
(b) The Authority may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm>
Provided that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised indications or from the use of an unauthorised medicinal product, when such use is recommended or required by the Authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. This shall apply irrespective of whether or not national or Community authorisation has been granted>
Provided further that liability for defective products, as provided for by Council Directive 85#374#EEC of 25 July, 1985 on the approximation of the laws, regulations and administrative provisions of the Member States, concerning liability for defective products shall not be affected by the preceding proviso.”.
7. Title I of part III of the principal Act shall be deleted from appearing before article 19 and shall be inserted to appear immediately before article 20.
8. Article 28 of the principal Act shall be amended as follows>- (a) for sub-articles (1) and (2) thereof, there shall be
substituted the following>
“(1) The Licensing Authority shall suspend, revoke, withdraw or vary the marketing authorization for a medicinal product, ensure that the supply of the medicinal product is prohibited and order its withdrawal from the market if>
(a) the medicinal product is harmful under normal conditions of use< or
(b) it lacks therapeutic efficacy, where such lack of therapeutic efficacy shall be deemed as occurring when it is concluded that therapeutic results cannot be obtained from the medicinal product< or
(c) the risk benefit balance is not favourable under the authorised conditions of use< or
(d) its qualitative and quantitative composition is not as declared< or
(e) the controls on the medicinal product and, or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out, or if the requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled>
Provided that the Licensing Authority may limit the prohibition to supply the medicinal product, or its withdrawal from the market, to those batches which are the subject of dispute.
(2) An authorisation shall also be suspended, revoked, withdrawn or varied 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.”< and
(b) immediately after sub-article (5) thereof shall be added the following new articles>
“(6) The Licensing Authority shall suspend or revoke the marketing authorization for a category of preparations or all preparations where the provisions of Title II are not complied with.
C 189
C 190

Amendment of article 32 of the principal Act.

Amendment of article 41 of the principal Act.

Substitution of article 49 of the principal Act.

Amendment of articles 50,51, 52 and 53 of the principal Act.

Amendment of article 80 of the principal Act.

Amendment of article 83 of the principal Act.

Amendment of article 87 of the principal Act.

Amendment of article 99 of the principal Act.

Amendment of article 101 of the principal Act.

Amendment of article 102 of the principal Act.

(7) The provisions of this article and of articles 99 to
104, shall apply to homeopathic medicinal products.”.
9. In sub-article (1) of article 32 of the principal Act, for the words “Homeopathic medicinal products” there shall be substituted the words “Without prejudice to article 28 of this Act, homeopathic medicinal products”.
10. In sub-article (1) of article 41 of the principal Act, the words
“under this Act” shall be deleted.
11. For article 49 of the principal Act, there shall be substituted the following>-
“49. The provisions of articles 37 to 48 shall apply to the manufacture and assembly of homeopathic medicinal products.”.
12. In articles 50, 51, 52 and 53 of the principal Act, the words “other than the products listed in article 32(a) (b) and (c)”, wherever they occur shall be deleted.
13. In sub-article (2) of article 80 of the principal Act, the words
“, formulation” shall be deleted.
14. In article 83 of the principal Act, for the words “or official formula” there shall be substituted the words “or officinal formula”.
15. In article 87 of the principal Act, for the words “official formulas” there shall be substituted the words “officinal formulas” and for the word “pre-packing” there shall be substituted the words “division of authorised packs into smaller units”.
16. In paragraph (e) of subarticle (1) of article 99 of the principal
Act, the words “66(1)” shall be deleted.
17. In article 101 of the principal Act, in sub-article (1) thereof, for the words “to enter any premises>” there shall be substituted the words “to enter and carry out repeated and unannounced inspections at any premises>”.
18. Article 102 of the principal Act shall be amended as follows> (a) in paragraph (c) of sub-article (1) thereof, for the words
“to those processes.” there shall be substituted the words “to those
processes>” and, immediately thereafter, there shall be added the following provisos to the whole sub-article>-
“Provided that an authorized officer may also carry out inspections of starting material manufacturers after a specific request for the purpose is made by such manufacturer himself>
Provided further that the samples that may be collected may be analysed at a designated laboratory identified by the Authority.”<
(b) immediately after paragraph (b) of sub-article (3) thereof, there shall be added the following new paragraph>
“(c) to take photographs of any equipment, premises, records and documents.”< and
(c) immediately after sub-article (7) thereof, there shall be inserted the following new sub-articles>
“(8) After every inspection the authorized officer shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice or, where appropriate, with the requirements relating to pharmacovigilance. The content of such reports shall be communicated to the manufacturer or marketing authorisation holder who has undergone the inspection.
(9) Within 90 days of an inspection a certificate of good manufacturing practice shall be issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice as provided for by legislation in force at the time.”.
19. Immediately after sub-article (4) of the principal Act, there shall be added the following new sub-article>-
“(5) Where any medicinal product has been seized under the provisions of this Act, and the owner thereof consents in writing to the destruction of such medicinal product the Licensing Authority may after taking such samples as may be required to prove the offence, direct that the said medicinal product be destroyed, without prejudice to the taking of any proceedings against the person responsible for the offence, and the said Licensing Authority shall recoup all the expenses involved in the destruction of the medicinal product.”.
C 191

Amendment of article 103 of the principal Act.

C 192

Addition of new article 104A to the principal Act.

20. Immediately after article 104 of the principal Act, there shall be added the following new articles>

“Proof of controls carried out.

104A. (1) The holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, shall furnish proof of the controls carried out on the medicinal product and, or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 8(3)(h) of Directive 2001#83
EC and any amendments thereto.
(2) Manufacturers of immunological products shall submit to the Authority copies of all the control reports signed by the qualified person.
(3) Where the Authority considers it necessary in the interests of public health, it may require the holder of an authorization for marketing>
(a) live vaccines,
(b) immunological medicinal products used in the primary immunization of infants or of other groups at risk<
(c) immunological medicinal products used in public health immunization programmes,
(d) new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization,
to submit samples from each batch of the bulk and, or the medicinal product for examination by a laboratory designated for that purpose before release on to the market unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. The Authority shall ensure that any such examination is completed within
60 days of the receipt of the samples.
(4) In the interests of public health, the Authority may require the marketing authorization holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and, or the medicinal product for testing by a laboratory designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. The Authority shall ensure that any such examination is completed within 60 days of the receipt of the samples.”.
21. For paragraph (q) of article 106 of the principal Act there shall be substituted the following>-
“(q) the fees that may be levied by the Licensing Authority, the Medicines Authority and any other committee established by or under this Act or regulations made thereunder,”.
22. Immediately after article 109 of the principal Act, there shall be added the following new article>
C 193

Amendment of article 106 of the principal Act.

Addition of new article 110 in the principal Act.

“Saving provisions.

110. (1) Nothing in this Act shall in any way derogate from any Acts or regulations for the radiation protection of persons undergoing medical examination or treatment, or from the Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation.
(2) This Act shall be without prejudice to Council Decision 86#346#EEC of 25 June 1986 accepting on behalf of the Community the European Agreement on the Exchange of Therapeutic Substances of Human Origin.
(3) The provisions of this Act shall not affect the powers of the Authority either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions.
(4) This Act shall not affect the application of any law prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients.”.
C 194

Objects and Reasons

The objective of this Bill is to amend the Medicines Act, 2003, which regulates medicinal products for human use and related pharmaceutical activities. This amendment is required in order to transpose the new EU requirements into national legislation, thus bringing it in line with EU legislation currently in force. Directive 2001#83#EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, has been amended by Directives
2004#24#EC and 2004#27#EC of the European Parliament and of the Council of 31
March 2004.