Regulation (EU) No 536/2014 of the European Parliament and of the CouncilShow full title

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)

Article 93U.K.Data protection

1.Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.

2.Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission and the Agency pursuant to this Regulation.