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Veterinary products

Commission Directive 2009/9/EC of 10 February 2009 amends Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use.

Paragraph 6 of Directive 2009/9/EC requires that pharmacological, toxicological, residue and safety tests shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC and Directive 2004/9/EC.

Chapter II on the presentation of particulars and documents specifies that each study report shall include a statement of compliance with good laboratory practice, if applicable.

The EU receiving authority for Commission Directive 2009/9/EC is the European Medicines Agency (EMA).

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

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