Consultation ML X375 seeks 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 now published our formal consultation on draft consolidated regulations and proposals for policy changes. We would encourage responses from all interested parties. The consultation is open for 12 weeks, and comments are invited by Tuesday 17 January 2012.
Please respond using the forms provided in Annex G
(89Kb) and Annex H
(29Kb) below.
We would encourage responses to be sent to the email address below if possible, but they can alternatively be sent to the postal address below.
Email: medicines.consolidation@mhra.gsi.gov.uk
Postal address for responses:
Stephen Fawbert
MHRA
Area 5-M
5th Floor
151 Buckingham Palace Road
LONDON
SW1W 9SZ
Download documents:
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Public consultation (MLX 375): Consolidation and review of UK medicines legislation (560Kb)
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MLX375: Annex A - Draft consolidated regulations (1438Kb)
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MLX375: Annex B - Consolidation Impact Assessment (96Kb)
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MLX375: Annex C - Repeal of section 10(7) impact assessment (190Kb)
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MLX375: Annex D - Legislation within scope of the consolidation (41Kb)
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MLX375: Annex E - Description of each part of the consolidated regulations (23Kb)
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MLX375: Annex F – Table of origins (199Kb)
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MLX375: Annex G - Response sheet(89Kb)
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MLX375: Annex H - Confidentiality template(29Kb)
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MLX375: Annex I - Consultation list (52Kb)

