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 may 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 are calculated from the first grant of the marketing authorisation for the reference product.