Legal provisions of COM(2002)529 - Inspection and verification of good laboratory practice (GLP) (codified version) - Main contents
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dossier | COM(2002)529 - Inspection and verification of good laboratory practice (GLP) (codified version). |
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document | COM(2002)529 |
date | February 11, 2004 |
Contents
Article 1
2. For the purposes of this Directive, 'good laboratory practice' (GLP), shall mean laboratory practice conducted in accordance with the principles set out in Directive 2004/10/EC.
3. This Directive does not concern the interpretation and evaluation of test results.
Article 2
2. Where the provisions of paragraph 1 have been complied with, and the results of the inspection and verification are satisfactory, the Member State in question 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 2004/9/EC on ... (date)'.
Article 3
2. The authorities referred to in paragraph 1 shall inspect the laboratory and audit the studies in accordance with the provisions laid down in Annex I.
Article 4
This report shall contain a list of laboratories inspected, the date on which such inspection was carried out and a brief summary of the conclusions of the inspections.
2. The reports shall be forwarded to the Commission each year, not later than 31 March. The Commission shall communicate them to the Committee referred to in Article 7(1). The Committee may request information in addition to those elements mentioned in paragraph 1 of this Article.
3. Member States shall ensure that commercially sensitive and other confidential information to which they gain access as a result of GLP compliance monitoring activities is made available only to the Commission, to national regulatory and designated authorities and to a laboratory or study sponsor directly concerned with a particular inspection or study audit.
4. The names of laboratories subject to inspection by a designated 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.
Article 5
2. Where a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply with GLP to the extent that the integrity or authenticity of the studies it performs might be compromised, it shall forthwith inform the Commission. The Commission shall inform the other Member States.
Article 6
Should it not be possible for the Member States concerned to reach agreement, the Member States in question shall immediately inform the other Member States and the Commission, giving reasons for their decision.
2. The Commission shall examine as soon as possible the reasons put forward by the Member States within the Committee referred to in Article 7(1); it shall then take the appropriate measures in accordance with procedure referred to in Article 7(2). It may in this connection ask for expert opinions from the designated authorities in the Member States.
3. If the Commission considers that amendments to this Directive are necessary in order to resolve the matters referred to in paragraph 1, it shall initiate the procedure referred to in Article 7(2) with a view to adopting those amendments.
Article 7
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. The Committee shall adopt its Rules of Procedure.
Article 8
- cooperation between the authorities designated by the Member States in technical and administrative matters arising from the implementation of GLP, and
- the exchange of information on the training of inspectors.
2. The amendments necessary for the adaptation of the formula referred to in Article 2(2) and of Annex I to take account of technical progress shall be adopted in accordance with the procedure referred to in Article 7(2).
Article 9
References made to the repealed Directive shall be construed as being made to this Directive and shall be read in accordance with the correlation table in Annex III.