Today we’re looking at renewals submitted for Marketing Authorisations (MAs) granted through the Centrally Authorised Procedure (CAP).
For the basics on renewals please see my previous blog.
A quick recap on how CAP licences will be handled – also see my previous blog on this subject:
All existing MAs authorised through the CAP will automatically be converted into UK MAs. These UK MAs will be issued with a UK MA number before the end of the transition period. For further information please refer to Guidance on Converting CAPs to UK MAs.
How will renewals for converted Centrally Authorised Products (CAPs) be handled?
Firstly, 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 therefore stay the same.
Your UK MA will remain in force until a decision has been made on your renewal applications.
When should I submit my renewal?
You should still submit your renewal application 9 months before it expires.
What are the requirements for my submission?
The requirements for renewal submissions will remain the same for products authorised in the UK and should include the same documents currently required in the EU as detailed in the following guidance: CAP renewals and annual reassessments.
What Agency fees are required?
Fees apply for the first 5-year renewal of a MA which was granted for a new active substance. Where this applies it should be clearly stated in the cover letter. Details on current fees are included on the MHRA website (Fees). There will be no fees for:
Renewal applications for MAs which were not granted as new active substance
subsequent MA renewal applications
renewing conditional MAs
The full MHRA guidance can be found here.
To receive your complimentary Brexit licence review:
Contact us at firstname.lastname@example.org or submit the form on our Brexit page.
If you would like to discuss how Fusion Pharma can support you with CAP conversion and/or CAP renewals, please email us at email@example.com or phone us on +44 (0) 203 1379 799.