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Product Safety Act (Act No. V Of 2001) The Good Laboratory Practice Regulations, 2003. (L.N. 234 Of 2003 )

B 2723

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,468, 5 ta’ Settembru, 2003

Taqsima B

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IN exercise of the powers conferred by article 39 of the Product Safety Act, the Minister for Finance and Economic Affairs has, on the advice of the Malta Standards Authority, made the following regulations>
1. The title of these Regulations is the Good Laboratory
Practice Regulations, 2003.
2. Laboratories carrying out tests on chemical products, in accordance with the Dangerous Substances (Notification) Regulations,
2001, shall comply with the principles of good laboratory practice as laid down in the First Schedule to these regulations.
3. Regulation 2 shall apply also where other provisions provide for the application of the principles of good laboratory practice in respect of tests on chemical products to evaluate their safety for man and, or the environment.
4. The National Accreditation Body-Malta Standards Authority (NAB-MSA), hereinafter referred to as the competent authority, shall be responsible for verifying compliance with the principles of good laboratory practice of any testing laboratory in Malta claiming to use GLP, as referred to in regulation 2, in the conduct of tests on chemicals.
5. Should it be established on the basis of detailed evidence that the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of these regulations, it presents a danger to man and, or the environment, the Director responsible for Consumer Affairs may, on the advice of the Head of the Directorate responsible for Chemicals within the Malta Standards Authority, provisionally prohibit

Citation.

General Provisions

Duties of the Competent Authority

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Certification of

Results

Inspection and Verification of Good Laboratory Practice

or make subject to special conditions the marketing of that substance in
Malta.
6. Where a laboratory has carried out a test in accordance with regulation 2 of these regulations, it shall give a notice in writing to the person who commissioned the test and to the competent authority, stating that the test has been carried out in conformity with the principles of good laboratory practice.
7.1 This regulation shall apply to the inspection and verification of the organizational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.
2.2 This regulation is not concerned with the interpretation and evaluation of test results.
7.3 The compliance with GLP of any testing laboratory claiming to use GLP in the conduct of tests on chemicals shall be verified using the procedure laid down in this regulation.
4.4 Where the provisions of regulation 7.3 have been complied with, and the results of the inspection and verification are satisfactory, the competent authority may provide endorsement of a claim by a laboratory that it and the tests that it carries out comply with GLP, using the formula ‘Assessment of conformity with GLP according to Directive 88#320#EEC on ‘……… (date)’.
4.5 The competent authority shall inspect the laboratory and audit the studies in accordance with the provisions laid down in the Second Schedule to these regulations.
4.6 The competent authority shall ensure that commercially sensitive and other confidential information to which it gains access as a result of GLP compliance monitoring activities is made available only to those national and international bodies which the Minister may, from time to time, designate, and to a laboratory or study sponsor directly concerned with a particular inspection or study audit.
7.7 The names of the laboratories subject to inspection by the competent authority, their GLP compliance status and the dates upon which laboratory inspections or study audits have been conducted shall not be considered to be confidential.
8. Without prejudice to regulation 9, the competent authority shall accept the results of laboratory inspections and study audits on GLP compliance carried out by Member States of the European Community.
9. Where the competent authority has sufficient reason to believe that a laboratory in another State claiming GLP compliance has not carried out a test according to GLP, it may request further information from the competent authority of that State prior to taking a decision on whether to accept the test results.
10. As from such date as the Minister may, by notice in the Government Gazette, determine, the provisions of Article 6 of Council Directive 88#320#pEEC of the European Community shall apply in respect of measures taken pursuant to regulation 9.
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Recognition of GLP compliance status in other States

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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

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