Article 6 Due diligence declaration at the stage of final development of a product

For the utilisation of genetic resources and traditional knowledge associated with genetic resources users shall make the due diligence declaration pursuant to Article 7(2) of Regulation (EU) No 511/2014 to the F1relevant competent authority. That declaration shall be made by submitting the completed template set out in Annex III to this Regulation.

The due diligence declaration referred to in paragraph 1 shall only be made once, prior to the first of the following events occurring:

For the purposes of this Article and Annex III, ‘result of the utilisation’ means products, precursors or predecessors to a product, as well as parts of products to be incorporated into a final product, blueprints or designs, based on which manufacturing and production could be carried out without further utilisation of the genetic resource and traditional knowledge associated with genetic resources.

For the purposes of this Article and Annex III, ‘placing on the F3United Kingdom market’ means the first making available of a product developed via utilisation of genetic resources and traditional knowledge associated with genetic resources on the United Kingdom market, where making available means the supply by any means, for distribution, consumption or use on the United Kingdom market in the course of a commercial activity, whether in return for payment or free of charge. Placing on the market does not include pre-commercial trials, including clinical, field or pest resistance trials, nor the making available of unauthorised medicinal products in order to provide treatment options for individual patients or groups of patients.