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
Corrected by
Corrigendum to 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 of 27 May 2014)On page 28, Article 23(5):for:"Where the conclusion … is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of the Member State concerned.",read:"Where the conclusion … is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.".