Correspondence

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

A letter providing guidance on the conversion process was sent by email on 26 November 2018 to the Community MA holders.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2018
• Last updated: 9 October 2019 — See all updates

This publication was withdrawn on 31 January 2020

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

Documents

Letter to industry and accompanying guidance

PDF, 213 KB, 6 pages

Details

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. 9 October 2019

   Change of text within Stay up to date box.

2. 31 December 2018

   First published.