MHRA Offers More No-Deal Brexit Guidance on Conditional Marketing Authorizations
Posted 28 March 2019 | By
The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published additional guidance in case the UK exits the EU without a deal, this time on conditional marketing authorization (CMA) applications, marketing authorizations in exceptional circumstances, and scientific advice.
As for the CMA scheme, MHRA says it will have the same eligibility criteria as the EU scheme and that like in the EU, it is meant for treatments for serious and life-threatening diseases where no satisfactory treatment methods are available or where the product offers a major therapeutic advantage. A CMA, which will be valid for a year and will be renewable annually, may be granted when comprehensive clinical data is not complete but will be available soon, MHRA says.
“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,” MHRA says.
Eligibility for a CMA will be determined by the MHRA at the time of marketing authorization application (MAA) assessment, as there is not a specific application route for a CMA. “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,” MHRA adds.
Like the CMA scheme, the marketing authorizations under exceptional circumstances (because the condition to be treated is rare or because collection of full information is not possible or is unethical) will adhere to the same eligibility criteria as the EU scheme and designations made by the European Medicines Agency or other jurisdiction may be considered by MHRA.
“The MHRA is likely to impose specific obligations on the holder of a Marketing Authorisation that is approved under exceptional circumstances. These will be aimed at the provision of information on the safe and effective use of the product,” the guidance says.
As for scientific advice, the MHRA says it will continue to offer this service after the UK leaves the EU in the event of no deal.
“In the event of no deal, 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,” MHRA adds.
MHRA guidance and publications on a possible no deal scenario
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice in a no deal scenario