Consultation ML X375 sought your views on the draft consolidated medicines regulations and proposed policy changes to ensure that medicines legislation remains fit for purpose and reflects modern practice.
The current body of UK medicines legislation comprises the Medicines Act 1968 and approximately 200 statutory instruments. It has developed piecemeal since the Medicines Act 1968 came into force some 40 years ago and is fragmented, complex and often difficult to follow.
We have published our formal consultation on draft consolidated regulations and proposals for policy changes. We encouraged responses from all interested parties. The consultation was open for 12 weeks. The consultation is now closed.
- Public consultation (MLX 375): Consolidation and review of UK medicines legislation (560Kb)
- MLX375: Annex A - Draft consolidated regulations (1438Kb)
- MLX375: Annex B - Consolidation Impact Assessment (96Kb)
- MLX375: Annex C - Repeal of section 10(7) impact assessment (190Kb)
- MLX375: Annex D - Legislation within scope of the consolidation (41Kb)
- MLX375: Annex E - Description of each part of the consolidated regulations (23Kb)
- MLX375: Annex F – Table of origins (199Kb)
- MLX375: Annex G - Response sheet(89Kb)
- MLX375: Annex H - Confidentiality template(29Kb)
- MLX375: Annex I - Consultation list (52Kb)