REGULATION (EU) NO 536/2014 ON CLINICAL TRIALS AND VULNERABLE GROUPS

A complete review of the normative established for clinical trials in vulnerable patient is performed. To do that, the basis is the last European norm, that is, the 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 (Text with EEA relevance). It is checked all related to vulnerable patients from the previous European norm. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 and the corresponding transpositions into Spanish law by Royal Decree 223/2004, of February 6, 2004, whereby clinical drug trials and Law 29/2006 of 26 July, on guarantees and regulates use rational use of medicines and health products.