COM/2023/193 Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

Proposed EU act: Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 [EXTERNAL LINK]

Evidence received (updated as received):

Department of Health Initial Assessment of Impact (PDF, 246 pages, 5779KB)

UK Government Explanatory Memorandum on the proposed EU act - 10 July 2023 [PDF, 6 pages, 91KB]

Department of Health - Written Answers [PDF, 4 pages, 154KB]

Response from the Department of Health – 29 May 2025 [PDF, 2 pages, 155KB]

Response from the Medicines and Healthcare Products Regulatory Agency – 17 June 2025 [PDF, 2 pages, 128KB]

Response from the British Dental Association – 9 June 2025 [PDF, 2 pages, 134KB]

Relevant Official Report (Hansard) transcript: