Paragraph 11 Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal productF3

This paragraph establishes the time limits relating to granting a marketing authorisation under the procedure for a F1generic veterinary medicinal product.

An application for a marketing authorisation cannot be made until two years before the product may be placed on the market in accordance with this paragraph.

The product may not be placed on the market until the end of the longest of the following periods which is relevant—

Where the product—

the period mentioned in sub-paragraph (3)(a) is 14 years.

Where a patent in relation to a reference product has lapsed, the summary of product characteristics of the relevant generic product must be updated in order to include the protected information.

Where, as a result of a variation to an existing marketing authorisation a product is accorded a new marketing authorisation number any relevant protection period applies in relation to that product.

In this regulation “major species” means cattle, sheep (for meat production), pigs, chickens, dogs and cats.

Time limits in this paragraph are calculated from the first grant of the marketing authorisation for the reference product.