Due diligence declaration at the stage of final development of a product
Article 6
1. 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 competent authority of the Member State in which the user is established. That declaration shall be made by submitting the completed template set out in Annex III to this Regulation. 2. The due diligence declaration referred to in paragraph 1 shall only be made once, prior to the first of the following events occurring: (a) market approval or authorisation is sought for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources; (b) a notification required prior to placing for the first time on the Union market is made for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources; (c) placing on the Union market for the first time a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources for which no market approval, authorisation or notification is required; (d) the result of the utilisation is sold or transferred in any other way to a natural or legal person within the Union in order for that person to carry out one of the activities referred to in points (a), (b) and (c); (e) the utilisation in the Union has ended and its outcome is sold or transferred in any other way to a natural or legal person outside the Union. 3. 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. 4. For the purposes of this Article and Annex III, ‘placing on the Union market’ means the first making available of a product developed via utilisation of genetic resources and traditional knowledge associated with genetic resources on the Union market, where making available means the supply by any means, for distribution, consumption or use on the Union 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.