Conversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs) – letter to industry

Documents

Details

Stay up to date

Get ready for Brexit on 31 October 2019. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.

Sign up to email alerts to get the latest information

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

As stated in the guidance, the Medicines and Healthcare products Regulatory Agency will issue Product Licence (PL) numbers to Community MAs based on the existing UK practice for determining how many separate national licences are needed across a product range. A proposal setting out the allocated PL numbers will be sent to Community MA holders and published in early January 2019.

If your company holds one or more Community MAs and has not received our letter, please email capconversion@mhra.gov.uk so that 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 31 December 2018
Last updated 9 October 2019 + show all updates

  1. Change of text within Stay up to date box.
  2. First published.