Correspondence

Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letters to industry

Letters sent to industry outlining how to convert marketing authorisations.

From:
Medicines and Healthcare products Regulatory Agency
Published
21 January 2019
Last updated
9 October 2019 — See all updates

This publication was withdrawn on

For current information on Conversion of Community Marketing Authorisations see European Medicines Agency: Marketing Authorisation

Documents

Letter to industry on Centrally Authorised Products conversion (inflight)

PDF, 40.3 KB, 1 page

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Letter to industry on Centrally Authorised Products conversion (no reply)

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Letter to industry on Centrally Authorised Products conversion (reply rescinded)

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Letter to industry on Conversion of Community Marketing Authorisations to UK Marketing Authorisations

PDF, 85.3 KB, 2 pages

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Details

The legislation that will come into force in a no-deal Brexit will, subject to being approved by Parliament, automatically convert Community Marketing Authorisations (CMAs) into UK Marketing Authorisations (MAs) on 31 October 2019 (so-called ‘grandfathering’).

To facilitate the grandfathering process. The MHRA has sent a letter to MAHs that sets out the actions that companies are requested to take concerning authorised Community Marketing Authorisations (CMAs) or inflight CAPS.

We have allocated a PL number based on each presentation within the product range rather than a separate number for each pack size. This means that there will usually be fewer UK authorisation numbers issued compared with those issued by the European Medicines Agency.

If your company holds one or more CMA and has not received this second letter, please email capconversion@mhra.gov.uk so we can verify the appropriate contact details.

For more information see our guidance on Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes.

Published 21 January 2019
Last updated 9 October 2019 + show all updates

  1. Change of text within Stay up to date box.

  2. Published three new letters sent to industry regarding conversion of Community Marketing Authorisations to UK Marketing Authorisations

  3. First published.