What’s changed?

Post 1 January 2021, if a UK company wishes to obtain a MA that allows a medicinal product to be placed on the market in the UK and EU, they must make an application to the EMA as well as the MHRA.

Whilst this doubles the paperwork, at present, the MA standards and procedures are extremely similar for both applications at present, as the UK has not changed the substantial requirements for a licence, and it is still based on EU law. 

Centrally Approved Marketing Authorisations

For medicinal products which were placed on the market in the UK before 1 January 2021, via a centrally approved EMA marketing authorisation (“CAP”), under the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 all CAPs were automatically entitled to a nationally recognised MA in the UK on 1 January 2021, and so the CAP will continue to apply across EU and UK.

UK Marketing Authorisations

UK licenses approved prior to 1st of January 2021 remain valid but may require attention.

Products approved in the UK via the Decentralised Procedure (“DCP”)/Mutual Recognition Procedure (“MRP”) before 1 January 2021 were issued with national UK MAs and the Marketing Authorisation Holder (MAH) now has the option to do one of the following:

  1. Maintain a UK-wide marketing authorisation.

The authorisation will continue to be a UK-wide MA with Northern Ireland as a Connected Member State.

This will be the default position and no action will need to be taken by the MAH.

  1. Request that separate MAs are issued for:
    1. UK(NI) as a CMS, and
    2. Great Britain (England, Wales and Scotland)
  1. Notify the UK and the RMS (reference member state) in writing that they wish to remove UK(NI) as a CMS from the DCP/MRP and maintain a national MA in Great Britain only.[1]

In terms of making variations to these UK MAs in the future, See also guidance on variations

We hope you found this brief article interesting, but please be aware that the procedure for placing a medicinal product on the market is intricate and this article does not constitute legal advice.

Please reach out to Wendy Lloyd-Goodwin (wendy@lslawservices.com ) at Life Science Law with any queries.

© Life Science Law 2nd March 2021.

[1] Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending – GOV.UK (www.gov.uk)