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Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States article 3 CELEX: 32014D0556 Conditions for the Union’s financial contribution
1. The Union’s financial contribution shall be conditional upon the following: (a) the demonstration by the Participating States that the EDCTP2 Programme is set up in accordance with Annexes I, II and III; (b) the designation by the Participating States or organisations designated by the Participating States of the EDCTP2-IS, an entity with legal personality, as the structure responsible for implementing the EDCTP2 Programme and for receiving, allocating and monitoring the Participating States’ contribution, as well as the Union’s financial contribution; (c) the demonstration by the EDCTP2-IS of its capacity to implement the EDCTP2 Programme, including receiving, allocating and monitoring the Union’s contribution in the framework of indirect management of the Union budget in accordance with Articles 58, 60 and 61 of Regulation (EU, Euratom) No 966/2012; (d) the establishment of a governance model for the EDCTP2 Programme in accordance with Annex III; and (e) the commitment by each Participating State to contribute to the financing of the EDCTP2 Programme. |
Decision No 556/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States article 3 CELEX: 32014D0556 2. During the implementation of the EDCTP2 Programme, the Union’s financial contribution shall be conditional upon the following: (a) the implementation by the EDCTP2-IS of the objectives set out in Annex I, and activities set out in Annex II, to this Decision, in particular the activities and indirect actions that it funds, in compliance with Regulation (EU) No 1290/2013 as referred to in Article 6 of this Decision; (b) the maintenance of an appropriate and efficient governance model for the EDCTP2 Programme in accordance with Annex III; (c) the compliance by the EDCTP2-IS with the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012; and (d) the fulfilment of the commitments referred to in point (e) of paragraph 1. |