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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   Consultation on proposals for legislative changes for clinical trials Page summary: We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines Change made: Government response…
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March 31, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   Submitting an application for review by the ACBS Page summary: How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS). Change made: Added ‘11 March 2024 – closing date for submissions is 15 January 2024’ under the heading ‘ACBS meetings and…
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March 31, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA has confirmed EU amendment to MDR will apply in Northern Ireland

MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…
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March 31, 2023
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