Written question asked by Lord Taylor of Holbeach (Conservative), in the House of Lords. It was answered by Lord Davies of Oldham (Labour) on Tuesday, 23 February 2010.

Veterinary Medicine Regulations 2009

Question: To ask Her Majesty’s Government whether paragraph 11 of Schedule 1 to the Veterinary Medicine Regulations 2009 (SI 2009/2297) means that a product will not receive marketing authorisation for 10 years after the initial authorisation (in the case of products for bees or fish, 13 years), regardless of its benefits compared to its pharmacologically equivalent product.

Answer: If an application is made using the procedure for a pharmacologically equivalent medicinal product, then the time limits referred to in paragraph 11—and, if appropriate, paragraph 12—of Schedule 1 to the Veterinary Medicine Regulations 2009 (SI 2009/2297) will apply. These time limits are set in Article 13 of European Directive 2001/82/EC (as amended). If products are pharmacologically equivalent then this means that their safety and efficacy in the target species should in effect be the same and therefore the pharmacologically equivalent product should not have any clinical benefits over the existing product. If a company generates the complete quality, safety and efficacy data for a veterinary medicine, they may apply at any time for a marketing authorisation under paragraph 2 of Schedule 1.

Secondary information