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Detailed guide: Renewing Marketing Authorisations for medicines after Brexit

Medicines Healthcare Products Regulatory Agency

October 24
12:42 2019

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A Brexit deal has been agreed but needs to be ratified. The UK could still leave with no deal on 31 October 2019 if the UK and EU do not approve and sign the withdrawal agreement.

This page tells you how to prepare for Brexit and will be updated if anything changes. Sign up for email alerts to get the latest information.

The Medicines and Healthcare products Regulatory Agency (MHRA) will be the UKs medicines regulator if theres a no-deal Brexit. They will carry out all functions currently done at EU level, including making decisions on Marketing Authorisation (MA) applications and renewals.

Youll need to continue submitting applications for MA renewals in the same way as before. These will be processed by the MHRA as national renewals.

Centrally authorised products (CAPs) converted from EU to UK MAs will be treated as if they were granted on the date the corresponding EU MA was granted. The renewal date will stay the same.

There will be special transitional arrangements for the conversion of CAPs to national MAs.

Your MAs will remain in force until the MHRA has made a decision on your renewal applications.

Renewals submitted before Brexit for MAs granted through mutual recognition or decentralised procedures

If youve submitted renewals for MAs granted through mutual recognition (MRP) or decentralised (DCP) procedures and do not get a decision before the day the UK leaves the EU, you will not need to resubmit them.

The MHRA will take over the renewal process and will aim to observe the relevant procedural time periods.

They will take into account how far through the process your application is, any information youve previously submitted and any assessment undertaken.

If a final decision has been made on your renewal but it hasnt been processed in the UK before Brexit, the MHRA will implement the agreed outcome.

Renewals submitted after Brexit

If theres a no-deal Brexit, you should continue to submit your renewal applications to the MHRA, 9 months before they expire.

Include the same documents currently required in the EU for:

The UK will continue to follow the reduced submission requirements for renewals of MAs for products authorised under Article 10.1.

Conditional Marketing Authorisations

If theres a no-deal Brexit, you should continue to submit your renewal applications for conditional MAs to the MHRA, 6 months before they expire.

The MHRA will consider the application in accordance with new regulation 66B of the Human Medicines Regulations 2012.

The same applies to converted EU MAs that were granted as conditional MAs.

Changes to fees

The new fees will be:

  • 9,682 for the first renewal of a product containing a new active ingredient at the time of authorisation
  • 747 for related applications made at the same time as the first renewal

There will be no fees for:

  • subsequent MA renewal applications
  • renewing conditional MAs
Published 18 March 2019
Last updated 24 October 2019 +show all updates
  1. Now more accessible with no change to the actual content.
  2. First published.

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