Paragraph 11 Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product

This paragraph establishes the time limits relating to granting a marketing authorisation under the procedure for a pharmacologically equivalent 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 shall not be placed on the market until ten years (or, in the case of medicinal products for fish or bees where the application for a marketing authorisation was submitted after 30th October 2005, thirteen years) have elapsed from the initial authorisation of the reference product.

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