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The Malta Standards Authority And Various Laws (Amendment) Act (Act No. Xxix Of 2007)

An ACT to amend the Malta Standards Authority Act and Various Laws.

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>

Short title and commencement.

Amendment of the Malta Standards Authority Act, Cap.

419.

Amendment of article 3 of the principal Act.

1. (1) The short title of this Act is the Malta Standards Authority and Various Laws (Amendment) Act, 2007.
(2) This Act shall come into force on such date as the Minister responsible for the Malta Standards Authority may by notice in the Gazette establish, and different dates may be so established for different provisions and for different purposes of the Act.
Part I
2. This Part amends and shall be read and construed as one with the Malta Standards Authority Act, hereinafter in this Part referred to as “the principal Act”.
3. Article 3 of the principal Act shall be amended as follows> (a) in subarticle (2) thereof, for the words “The Authority
shall be governed by a Council” there shall be substituted the words
“The Authority shall have a Council which shall have the functions set out in subarticle (2A) hereof and”< and
(b) immediately after subarticle (2) thereof, there shall be added the following new subarticles>-
“(2A) The Council shall have the following functions>- (a) to determine the general policy and objectives
of the Authority within the context of the framework
policies established by Government<
(b) to act as a liaison point between the Authority and the sectors it represents, and other persons having an interest therein<
(c) to approve any agreement proposed under subarticle (11) of this article before such agreement is forwarded for the concurrence of the Minister in terms of the said subarticle<
(d) to approve the financial statements of the
Authority<
(e) to guarantee the functional independence of the Directorates.
(2B) With the exception of the Chairman, who shall act in his own individual judgement in the interests of the Authority, the members of the Council shall be appointed as representatives of the sectors they represent.”.
4. In sub-paragraph (ii) of paragraph (b) of article 16 of the principal Act, for the words “ensuring the availability” there shall be substituted the words “the availability or ensuring the availability”.
5. In subarticle (1) of article 19 of the principal Act, for the words “the standards and fulfil the conditions prescribed in the standards” there shall be substituted words “the standards and technical regulations and fulfil the conditions prescribed therein”.
Part II
6. This Part amends and shall be read and construed as one with the Product Safety Act, hereinafter in this Part referred to as “the principal Act”.
A 1243

Amendment of article 16 of the principal Act.

Amendment of article 19 of the principal Act.

Amendment to the Product Safety Act, Cap. 427.

A 1244

Amendment of article 2 of the principal Act.

7. Article 2 of the principal Act shall be amended as follows> (a) for the definition of the expression “Director” therein
there shall be substituted the following>-
“ “Director” means the Head of the Market Surveillance Directorate of the Malta Standards Authority established by article 3 of the Malta Standards Authority Act or such other head of any Directorate as the Minister may by Order designate in his stead and includes, to the extent of the authority given, any officer authorised by such head, in writing, to act in that behalf for any of the purposes of this Act<”<
(b) the definition of the expression “Department” therein shall be deleted< and
(c) for the definition “safe product” therein there shall be substituted the following>–
“safe product” means any product which, under normal or reasonably foreseeable conditions of use, including duration, and, where applicable, putting into service, installation and maintenance requirements does not present any risk or only the minimum risks, compatible with the product’s use, which are considered as acceptable and consistent with a high level of protection for the safety and health of persons, taking into account in particular the following factors>
(a) the characteristics of the product, including its composition, packaging, instructions for assembly and maintenance<
(b) the effect on other products, where it is reasonably foreseeable that it will be used with other products<
(c) the presentation of the product, the labelling, any instructions for its use and disposal and any other indication or information provided by the producer<
(d) the categories of consumers at risk when using the product, in particular children, the disabled and the elderly>
Provided that the possibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be an unsafe product<”.
8. For article 27 of the principal Act that shall be substituted the following>-
A 1245

Substitution of article 27 of the principal Act.

“Functions of the Malta Standards Authority.

“27. Without prejudice to any other functions assigned to it by any other law, the Malta Standards Authority, shall also have the following functions>
(a) to establish and periodically update sectoral surveillance programmes in respect of all categories of products and risks<
(b) to follow up and update scientific knowledge concerning the safety of products, as well as periodical reports on surveillance activities, findings and results achieved<
(c) to periodically review and assess the functioning of the control activities and their effectiveness, and, if necessary, revise the surveillance approach and organisation put in place.”.
9. In article 22 of the principal Act, the words “of the
Department,” shall be deleted.
10. In subarticle (1) of article 28 of the principal Act, for the words “may, with the concurrence of the Director of Market Surveillance, make or” there shall be substituted words “may, with the concurrence of the head of the Regulatory Affairs Directorate established under the Malta Standards Authority Act or such other head of any Directorate as the Minister may by Order designate in his stead”.
11. Immediately after paragraph (k) of article 38 of the principal
Act there shall be added the following new paragraph>
“(l) designating any manufactured article, item or substance as a ‘product’ for all or any purposes of this Act.”.

Amendment of article 22 of the principal Act.

Amendment of article 28 of the principal Act.

Amendment of article 38 of the principal Act.

A 1246

Amendment to the Pesticides Control Act, Cap. 430.

Amendment of Article 2 of the principal Act.

Cap. 419.

Amendment of article 10 of the principal Act.

Amendment to the Food Safety Act, Cap. 449.

Amendment of article 7 of the principal Act.

Part III
12. This Part amends and shall be read and construed as one with the Pesticides Control Act, hereinafter in this Part referred to as “the principal Act”.
13. Article 2 of the principal Act, shall be amended as follows>- (a) immediately after the definition of the expression
“authorisation” therein there shall be added the following new
definition>-
“ “the Authority’’ means the Malta Standards Authority established by article 3(1) of the Malta Standards Authority Act or such other Directorate as the Minister may by Order designate in its stead<”<
(b) in the definition of the expression “Director” therein, for the words “Director of the Department” there shall be substituted the words “the head of the Regulatory Affairs Directorate established under the Malta Standards Authority Act or such other head of any Directorate as the Minister may by Order designate in his stead”< and
(c) the definition of the expression “Department” shall be deleted.
14. In paragraph (d) of sub-article (2) of article 10 of the principal Act, for the words “Malta Standards Authority” there shall be substituted the words “Plant Health Department”.
Part IV
15. This Part amends and shall be read and construed as one with the Food Safety Act, hereinafter in this Part referred to as “the principal Act”.
16. Immediately after Article 7 of the principal Act there shall be inserted the following new article>

Cap. 419.

“The Commis- sion to exercise functions through the Authority.

7A. (1) The Commission shall exercise its functions under article 7(1) (b), (c), (d), (e), (g), (h), (j) and (l) through the Malta Standards Authority as established by article 3 of the Malta Standards Authority Act.
(2) The Malta Standards Authority shall also issue such guidelines as may be necessary in relation to the functions mentioned in subarticle (1) of this article.
(3) The Commission may demand from the Malta Standards Authority any information obtained or report drawn up by the Authority in the exercise of its functions under this article and the Authority shall comply with any such demand.
(4) The functions of the Malta Standards Authority under this article shall be without prejudice to any other functions assigned to it by any other law.”.
17. In subarticle (1) of article 9 of the principal Act, for the words “the Director of the Market Surveillance Directorate” there shall be substituted the words “the head of the Market Surveillance Directorate of the Malta Standards Authority established under the Malta Standards Authority Act or such other head of any Directorate as the Minister may by Order designate in his stead.”.
Part V
18. This Part amends and shall be read and construed as one with the Medicines Act, hereinafter in this Part referred to as “the principal Act”.
19. For article 4 of the principal Act there shall be substituted the following>-
“4. There shall be established a Medicines Authority, or such other authority as the Prime Minister may, after consultation with the Minister responsible for health, designate in terms of article
110 of this Act.”.
20. For subarticle (5) of article 103 of the principal Act there shall be substituted the following>
“(5) (a) 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.
A 1247

Amendment of article 9 of the principal Act.

Amendment to the

Medicines Act, Cap.

458.

Substitution of article 4 of the principal Act.

Amendment of article 103 of the principal Act.

A 1248

Addition of new article 110 to the principal Act.

(b) In those cases where the owner fails to consent to the destruction of the medicinal product, the Licensing Authority may, after filing an application requesting the Court to order the destruction at the expense of the owner, proceed with such destruction.”.
21. Immediately after article 109 of the principal Act there shall be added the following>

“Designation of competent authority.

110. (1) The Prime Minister may, following consultation with the Minister responsible for health, by Order in the Gazette designate any authority to carry out the functions carried out by the Medicines Authority under this Act.
(2) Any such Order may delete any of the provisions of articles 5 and 7 to 13 of this Act.
(3) Any such Order may also amend or delete subarticle (3) of article 3 and articles 4 and 6 of this Act.”.
__________
Passed by the House of Representatives at Sitting No. 602 of 12th December,
2007.
ANTON TABONE

Speaker

RICHARD J. CAUCHI

Clerk to the House of Representatives

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

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

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