Last updated: 3 April 2025
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This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format.
Always read the information on this procedure published on the MHRA website for the most up to date and complete information.
For what medicines is the MHRA scheme for marketing authorisation under exceptional circumstances available?
The MHRA’s scheme for applications under exceptional circumstances is 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.
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.
Who makes the final decision on the eligibility of a product to the scheme?
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 UK scheme will rest with the MHRA.
Under what regulation is the scheme for marketing authorisation under exceptional circumstances covered?
The scheme is covered under Human Medicines Regulations 2012, Regulation 60, ‘Conditions of UK marketing authorisation: exceptional circumstances’.
Is there a requirement for an applicant to discuss their submission with the MHRA prior to submitting a Marketing Authorisation Application under this scheme?
Yes, applicants are required to discuss their submissions with the MHRA prior to submitting their Marketing Authorisation Application.
Does this authorisation route lead to a standard marketing authorisation?
No, this authorisation route does not normally lead to a standard marketing authorisation.
Does a marketing authorisation granted by the MHRA via this scheme include Northern Ireland?
Until 1 January 2025 applications for Marketing Authorisations under Exceptional Circumstances in Northern Ireland had to be submitted to the EMA. From that date the MHRA can issue them as UK-wide MAs.
Is the MHRA likely to impose specific obligations on the MAH holder approved under exceptional circumstances?
Yes, 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.
Source: MHRA