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
Modified by
Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use (Text with EEA relevance)
December 5, 2022 annex VI section B point 6 Amendment
December 5, 2022 annex VI section B paragraph B.6.3 Addition
December 5, 2022 annex VI section D section D.9 point (d) Replacement
December 5, 2022 annex VI section A section A.2.1.4 point (e) Replacement
December 5, 2022 annex VI section A section A.2.2.5 point (f) Replacement
December 5, 2022 annex VI section D section D.9 point (e) Addition
December 5, 2022 annex VI section B paragraph B.6.2 Addition
December 5, 2022 annex VI section D section D.9 point (b) Replacement
December 5, 2022 annex VI section D section D.9 point (c) Replacement
December 5, 2022 annex VI section A section A.2.2.5 point (e) Replacement
December 5, 2022 annex VI section A section A.2.1.4 point (f) Replacement