COM/2023/192 Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

Proposed EU Act: Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC [EXTERNAL LINK]

Evidence received (updated as received):

Department of Health Initial Assessment of Impact (PDF, 246 pages, 5778KB)

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: