1 Amendments of Simona BALDASSARRE related to 2020/0321(COD)
Amendment 204 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) In order to ensure the full application of Article 35 of Regulation (EU) no.536/2014 of the European Parliament and of the Council 1a, with regard to emergency clinical trials on subjects unable to provide informed consent, a special independent monitoring committee for emergency clinical trials is setup, in order to avoid the duplication of similar studies that could harm the human dignity and to ensure closer pharmacovigilance due to the particularity of the trial in question. _________________ 1a Regulation (EU) no 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union L 158/1, p. 34. https://ec.europa.eu/health/sites/health/fil es/files/eudralex/vol- 1/reg_2014_536/reg_2014_536_en.pdf