Paragraph 10 Application for a generic veterinary medicinal productF13E1

F1Subject to sub-paragraphs (2A), (9) and (10) and paragraph 10A, an applicant need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant can demonstrate that the veterinary medicinal product is F2a generic of a veterinary medicinal product already authorised in the F3United Kingdom F4(“the reference veterinary medicinal product”), provided that the applicant provides data demonstrating the matters referred to in sub-paragraph (2).

For the purposes of this paragraph a product is F5a generic of an existing product if—

Sub-paragraph (1) does not apply to applications for biological (including immunological) veterinary medicinal products.

For the purposes of this paragraph—

Different immediate-release oral pharmaceutical forms are regarded as the same pharmaceutical form.

Bioavailability studies are not required if the bioequivalence guidelines produced by the F9European Medicines Agency F10or the Secretary of State exempt the product.

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For the purposes of these Regulations, subject to sub-paragraph (8), the summary of product characteristics of a generic veterinary medicinal product must be essentially similar to the summary of product characteristics for the reference product.

The requirement in sub-paragraph (7) does not apply in relation to those parts of the summary of product characteristics of the reference product that refer to indications or pharmaceutical forms which are covered by patents at the time when the generic veterinary medicinal product is authorised.

Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products intended to be administered by intramuscular, subcutaneous or transdermal routes, the applicant must provide—

Notwithstanding sub-paragraph (1), in respect of generic veterinary medicinal products containing antimicrobial or antiparasitic substances, the applicant must provide all available data (including published data) on the current level of resistance, together with a review of that data as it relates to target pathogens to the active substances concerned.

An applicant must provide an environmental risk assessment for a generic veterinary medicinal product where—

unless the Secretary of State holds an environmental risk assessment for the reference veterinary medicinal product and has confirmed this to the applicant.