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Parliamentary questions
27 July 2017
E-003525/2017
Answer given by Mr Andriukaitis on behalf of the Commission

For collaborative projects focused on pharmaceutical research under the EU Framework Programme for Research and Innovation Horizon 2020 Societal Challenge n°1 (Health, Demographic Change and Wellbeing)(1), after a preliminary ad-hoc analysis, Greece currently holds the 16th rank among the EU Member States.

For the projects funded under the 2nd Innovative Medicines Initiative (IMI2), Greece currently holds the 19th rank (it held the 13th rank under the previous partnership, IMI1)(2).

Regulation (EU) No 536/2014 on Clinical Trials(3), which sets streamlined procedures and strict timelines for the assessment of clinical trials applications, will be directly applicable in all Member States of the EU and will replace current national legislation adopted in order to transpose Directive 2001/20/EC(4).

The entry into application of the Clinical Trials Regulation is linked to the full functionality of the EU Clinical Trials Portal and Database, developed by the European Medicines Agency. The Commission has not assessed the compliance of Article 78 of Greek law No 4472/2017 with the Clinical Trials Regulation since a regulation is directly applicable in Member States.

In any case, the Clinical Trials Regulation does not set the timelines and the procedures for the authorisation to place a new medicine on the market.

(1)http://ec.europa.eu/programmes/horizon2020/en/h2020-section/health-demographic-change-and-wellbeing
(2)https://www.imi.europa.eu/content/home
(3)Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ 27.05.2014, L158/01.
(4)Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ 1.05.2001, L121/34.

Last updated: 4 August 2017Legal notice