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Converting Centrally Authorised Products to UK Marketing Authorisations—post-Brexit transition guidance from MHRA

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Published on: 18 October 2021

Published by LNB News

LNB News 18/10/2021

Document Information

Issue Date: 18 October 2021

Published Date: 18 October 2021

Jurisdiction(s): England and European Union

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has added further guidance on what to submit if the converted licence should be cancelled in mainland UK between 21 December 2020 and 31 December 2021 to their guidance on 'converting Centrally Authorised Products (CAPs) and UK Marketing Authorisations (MA), 'grandfathering' and managing lifecycle changes' guidance. The addition includes information on the general approach to grandfathering of CAPs, actions that need to be taken by EU MA holders and specific circumstance-based guidance on conversions. While the Brexit transition/implementation period ended at 11pm on 31 December 2020, the government continues to issue new and updated Brexit webpages and guidance documents on the associated legal and practical changes.

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