Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Guidance for Great Britain Conditional Marketing Authorisation Applications
The MHRA has introduced a national Conditional Marketing Authorisation (CMA) scheme for new medicinal products in Great Britain effective 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 has 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 continues to offer its national scientific advice service. 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.
There is 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.
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