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Decision No 556/2014/EU of the European Parliament and of the CouncilShow full title
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
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Changes over time for: Article 4
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Article 4U.K.Activities of the EDCTP2 Programme
1.The activities of the EDCTP2 Programme shall meet the objectives described in Annex I and shall comply with Annex II.
Activities may include national programme activities of Participating States, including activities undertaken by public or private not-for-profit research organisations, and new activities, including calls for proposals managed by the EDCTP2-IS.
Activities shall be included in the work plan of the EDCTP2 Programme adopted annually by the EDCTP2-IS (‘the EDCTP2 annual work plan’), following the positive outcome of their external evaluation by international peer review with regard to the objectives of the EDCTP2 Programme.
2.The EDCTP2 annual work plan shall detail the budgeted value of each activity and shall provide for the allocation of the funding managed by the EDCTP2-IS, including the Union’s financial contribution.
The EDCTP2 annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues.
3.The EDCTP2-IS shall implement the EDCTP2 annual work plan.
The EDCTP2-IS shall monitor and report to the Commission on the implementation of all the activities included therein or selected following calls for proposals managed by the EDCTP2-IS.
4.Activities included in the EDCTP2 annual work plan that are not funded by the EDCTP2-IS shall be implemented in compliance with common principles to be agreed by the Participating States and the Commission, taking into account the principles set out in this Decision, in Title VI of Regulation (EU, Euratom) No 966/2012 and in Regulation (EU) No 1290/2013, in particular the principles of equal treatment, transparency, independent peer review evaluation and selection. The Participating States and the Commission shall also agree on the reporting requirements to the EDCTP2-IS, including with regard to indicators inserted into each of those activities.
Any activity funded by the EDCTP2-IS in accordance with the EDCTP2 annual work plan, or following calls for proposals managed by the EDCTP2-IS, shall be considered to be an indirect action within the meaning of Regulation (EU) No 1290/2013, and shall be implemented in accordance with Article 6 of this Decision.
5.Any communication or publication in the area of the activities of the EDCTP2 Programme, and performed in close collaboration with EDCTP2, whether undertaken by the EDCTP2-IS, a Participating State, or participants to an activity, shall be labelled or co-labelled as ‘[name of the activity] is part of the EDCTP2 programme supported by the European Union’.
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