The MHRA acts as the regulator for products placed on the market in Northern Ireland. There are 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 remain in force until a decision has been made on your renewal applications.

Renewals submitted for MAs granted through mutual recognition (MR) or decentralised (DC) procedures

All holders of existing marketing authorisations (MAs), or applicants for MAs with applications submitted by 1 January 2021 and under review within a decentralised or mutual recognition procedure with UK as a CMS will have a choice on how to manage their marketing authorisations/applications.

Refer to the guidance on handling of decentralised and mutual recognition procedures.

The default position is to maintain a UK wide marketing authorisation and retain UK in respect of Northern Ireland (UK(NI) (UK in respect of Northern Ireland) as a CMS. In this case, the authorisation will continue to be a UK wide MA with Northern Ireland as a CMS and Great Britain aligned with, but not part of, the DCP/MRP.

Where this applies any pending applications will be processed to conclusion after 1 January 2021 as MR/DC renewals using the relevant MR/DC procedures led by the RMS.

New applications for a renewal of the MA should be submitted via the DCP/MRP and if approved would apply to the UK wide authorisation with Great Britain implementing the European decision unless the MHRA notifies the MAH within 30 days of the RMS decision that the decision cannot be accepted in Great Britain.

In this case, a separate MA for Great Britain would need to be issued. Other options include having separates MAs for UK(NI) as CMS, and Great Britain. Renewal applications for Great Britain MAs will be processed via the purely national route.

If you’ve submitted renewals for MAs granted through the the DCP/MRP 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

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:

• CAP renewals and annual reassessments
• Renewals for products authorised through MRP or DCP procedures

The MHRA will continue to follow the shortened renewal procedure accept the reduced submission requirements for national and MR/DCP renewals of MAs for products authorised under Article 10.1, 10c and 10.a as set out in the CMDh Best Practice Guide on processing renewals in the MRP/DCP.

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 fees are included below.

Annual renewal of Conditional Marketing Authorisations

You should continue to submit your renewal applications for conditional MAs 6 months before they expire.

See guidance on converting CAPS to UK MAs for advice on converted EU MAs which were granted as conditional MAs.

For Great Britain MAs your application should be submitted to the MHRA, who will consider the application in accordance with new regulation 66B of the Human Medicines Regulations 2012. There is no application form for a renewal of a conditional MA and the application form for a 5-year renewal of an MA is not applicable. Your application should include a cover letter accompanied by the same documents as currently required by the EU. The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.

There are no fees for conditional renewals.

Recognition route

Where an identical renewal application (for either a MA or a conditional MA) has been submitted for the centralised product the renewal application can be submitted for the Great Britain-MA.

Where this route is used it must be clearly indicated in the cover-letter and evidence of acceptance provided (the CHMP opinion) together with a copy of the final assessment report and any updates e.g. track-change of any updated product information, when available.

Where the application is not yet subject of a positive CHMP opinion the application will be put on hold until this has been received.

Once available the positive opinion and other documentation should be submitted to the MHRA via the portal.

For renewals a copy of the Commission Decision must be provided to the MHRA via the portal before the renewal can be concluded.

Where the application is for a first 5-year renewal of a MA which was granted for a new active substance, a reduced fee of £747 applies for the recognition route.

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
• A reduced fee (£747) will apply where the MA was granted via automatic recognition, unfettered access and applications submitted according to the recognition route.

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

Contact

For further information, please email our Customer Services Centre at RIS.NA@mhra.gov.uk. Alternatively, contact your Trade Association by emailing:

• Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
• British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
• BioIndustry Association (BIA): regulatory@bioindustry.org
• Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
• Ethical Medicines Industry Group (EMIG): info@emig.org.uk
• Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
• The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk