The way Marketing Authorisations (MAs) are processed will change after a no-deal Brexit.
The Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s medicines regulator if there’s 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.
You’ll 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.
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 you’ve 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 you’ve previously submitted and any assessment undertaken.
If a final decision has been made on your renewal but it hasn’t been processed in the UK before Brexit, the MHRA will implement the agreed outcome.
Renewals submitted after Brexit
If there’s 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 there’s 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