Renewing Medicine Authorisation 2021 UK Guidance

by
MedicinesUK Post-Exit Guidance Notes [2020]
Guidance

Renewing Marketing Authorisations for medicines from 1 January 2021

The way Marketing Authorisations (MAs) are processed will change from 1 January 2021.

Published 1 September 2020
Last updated 27 October 2020 — see all updates
From:
Medicines and Healthcare products Regulatory Agency

New rules for January 2021

The UK has left the EU, and the transition period after Brexit comes to an end this year.

This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.

For current information, read: Renew: marketing authorisation for a human medicine

You can also read about the transition period.

The Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s medicines regulator from 1 January 2021. This includes acting as the regulator for products placed on the market in Northern Ireland. There will be some different requirements for products placed on the market in the UK with respect to Great Britain (England, Scotland, Wales) and Northern Ireland.

Renewals for converted Centrally Authorised Products (CAPS)

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.

Please refer to Guidance on Converting Centrally Authorised Product (CAPS) to UK MAs.

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

Renewals submitted 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 1 January 2021, you will not need to resubmit them.

If a final decision has been made on your renewal but it hasn’t been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome.

Where a final decision has not been made, the MHRA will ensure that the renewal process is concluded and processed by the appropriate route.

Renewals submitted from 1 January 2021

From 1 January 2021, you should continue to submit your renewal applications 9 months before they expire.

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:

The MHRA will continue to accept the reduced submission requirements for renewals of MAs for products authorised under Article 10.1 as set out in the CMDh Best Practice Guide on processing renewals in the MRP/DCP.

Conditional Marketing Authorisations

From 1 January 2021, you should continue to submit your renewal applications for conditional MAs 6 months before they expire.

For Great Britain MAs the application should be submitted to the MHRA, who 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.

Renewals for MAs granted via unfettered access

Where you have a Great Britain-only MA granted via the Unfettered Access route, an application to renew the MA should be submitted in line with the above guidance. Where the MA has remained in line with the EU or Northern Ireland MA we will accept the same renewal application as submitted to the EU and a reduced fee will be applied.

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

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Published 1 September 2020
Last updated 27 October 2020 
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