Guidance for Great Britain Conditional Marketing Authorisation Applications
The MHRA will introduce a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products in Great Britain from 1 January 2021. Great Britain is England, Wales and Scotland. In Northern Ireland Marketing Authorisation applications for products which fall within mandatory scope of the Centrally Authorised Procedure as laid down in Regulation (EC) No 726/2004, must be submitted to the EMA.
The scheme will have the same eligibility criteria as the EU scheme and is intended for medicinal products that fulfill an unmet medical need. Examples would be for serious and life-threatening diseases where no satisfactory treatment methods are available or where the product offers a major therapeutic advantage.
The MHRA may grant a CMA where comprehensive clinical data is not yet complete, but it is judged that such data will become available soon.
Actions for those submitting a Marketing Authorisation Application (MAA)
The MAA must still contain adequate evidence of safety and efficacy to enable the MHRA to conclude that the risk-benefit balance of the medicinal product is positive.
Applicants wishing to submit an application for a conditional marketing authorisation to the MHRA should state their justification for a CMA and indicate clearly what clinical studies are underway and when comprehensive clinical data will become available.
Eligibility for a CMA will be determined by the MHRA at the time of MAA assessment.
There is no specific application route for a CMA; applicants should submit their MAA dossier as for a full Marketing Authorisation.
At the completion of the assessment of a MAA dossier, the MHRA will determine whether to approve the application and grant a conditional MA or whether the risk benefit ratio is negative and reject the application.
The designation of a product as being eligible for a CMA by the EMA or another jurisdiction may be taken into account by the MHRA, but the final decision on eligibility of the product for the Great Britain scheme will rest with MHRA.
CMAs will be valid for one year and will be renewable annually.
Guidance for Great Britain Marketing Authorisations under exceptional circumstances
The MHRA’s existing scheme for applications under exceptional circumstances will continue to be available for medicines where a comprehensive data package cannot be provided, because the condition to be treated is rare or because collection of full information is not possible or is unethical. Applications for Marketing Authorisations under Exceptional Circumstances in Northern Ireland must be submitted to the EMA.
This is covered under Human Medicines Regulations 2012, Regulation 60, ‘Conditions of UK marketing authorisation: exceptional circumstances’.
The scheme has the same eligibility criteria as the EU scheme. Approvals will only be granted under this scheme where there are exceptional circumstances and where the applicant can demonstrate that it is not possible to provide comprehensive data on the efficacy and safety under normal conditions of use.
The designation of a product as being eligible for an exceptional circumstances scheme by the EMA or another jurisdiction may be taken into account by the MHRA, but the final decision on eligibility of the product for the GB scheme will rest with MHRA.
Actions for those applying for UK marketing authorisations under exceptional circumstances
The MHRA is likely to impose specific obligations on the holder of a Marketing Authorisation that is approved under exceptional circumstances. These will be communicated to the applicant during the review and will be aimed at the provision of information on the safe and effective use of the product.
Applicants are required to discuss their submissions with the MHRA prior to submitting their Marketing Authorisation Application.
Guidance for national scientific advice after 1 January 2021
The MHRA will continue to offer its national scientific advice service after 1 January 2021. This service is available for developers of medicinal products and can be requested at any stage of the product’s development. The procedure for requesting scientific advice is described in further detail.
From 1 January 2021 there will be one change to the fees payable for scientific advice. Applications for scientific advice submitted by UK-based Small and Medium-sized Enterprises (SME) will be exempt from the fee. Applicants will be required to submit evidence of their SME status together with the scientific advice form.
Requests for advice that is purely regulatory in nature will remain free of charge.
This guidance will apply from 1 January 2021.
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.
Products placed on the market in Northern Ireland will need to be in line with EU legislation and follow EU requirements.
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.
There will be special transitional arrangements for the conversion of CAPs to national 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 remain the same 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 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.
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
How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
How the MHRA will assess Marketing Authorisation Applications (MAA) for medicines referred under Article 29 from 1 January 2021.
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: CMDh referrals guidance
You can also read about the transition period.
Article 29 referrals are triggered when a consensus cannot be reached between Member States on the outcome for a Marketing Authorisation Application (MAA) which has been evaluated in a mutual-recognition procedure (MRP) or decentralised procedure (DCP), on the grounds of a potential serious risk(s) to public health (PSRPH).
How we will treat MAAs at different stages of the process from 1 January 2021
For MAAs that have been referred under Article 29, where either a positive or negative opinion has been taken at the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) or the Committee for Medicinal Products for Human Use (CHMP) but no decision issued by 1 January 2021, the MHRA will either grant or refuse the application with regard to the relevant committee decision.
For all pending MAAs submitted in the UK, as a Concerned Member State (CMS), that have been referred under Article 29 before 1 January 2021 but no opinion has been reached by CMDh or CHMP, the MHRA will complete the assessment for Great Britain as a national procedure.
The MHRA assessment will take into account the existing RMS and CMS assessments with particular focus on the identified PSRPH. If the MHRA are minded to refuse an application based on a PSRPH, consultation with the Commission on Human Medicines (CHM) and other relevant expert advisory committees will take place.
On completion of the MHRA assessment, and consultation with expert advisory committees as required, the MHRA will issue its decision on approval or refusal of the Marketing Authorisation.
For applications where the MHRA had a positive opinion at Day 210 of a DCP or Day 90 of an MRP, and considered that the risk/benefit of the product is positive in the subsequent referral procedure, a Marketing Authorisation will be granted following receipt of the national product information.
No additional or different fee will be charged for applications that are completed as a national procedure having previously been referred under Article 29. If a Marketing Authorisation applicant does not wish the MHRA to continue with the DCP/MRP as a national application, the applicant should submit a withdrawal letter to the UK.
From 1 January 2021, Northern Ireland will continue to participate in referrals under Article 29 and will be bound by the outcome of the CMDh or CHMP decision.