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Commission Directive 2009/9/ECShow full title
Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)
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4.Combination veterinary medicinal products
For applications based on Article 13b, a dossier containing Parts 1, 2, 3 and 4 shall be provided for the combination veterinary medicinal product. It shall not be necessary to provide studies on the safety and efficacy of each active substance. It shall nevertheless be possible to include information on the individual substances in the application for a fixed combination. The submission of data on each individual active substance, in conjunction with the required user safety studies, residues depletion studies and clinical studies on the fixed combination product, may be considered a suitable justification for omitting data on the combination product, based on animal welfare grounds and unnecessary testing on animals, unless there is suspected interaction leading to added toxicity. Where applicable, information regarding the manufacturing sites and the safety evaluation of adventitious agents shall be provided.
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