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Medicinal products

Commission Directive 2003/63/EC of 25 June 2003 amends Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use.

Paragraph 9 requires that non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice.

Section 2.2 Module 4 (Part III of the Commission Directive) on radio-pharmaceutical precursors for radio-labelling purposes requires that for single dose and repeated dose toxicity, the results of studies carried out in conformity with the provisions related to good laboratory practice shall be provided, unless otherwise justified.

The EU receiving authority for Commission Directive 2003/63/EC is the European Medicines Agency (EMA).

Further information on medicinal products can be found on the website of the European Commission's Directorate General for Health and Consumers (DG SANCO).

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