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Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Register as a manufacturer, importer or distributor of active substances for use in veterinary medicines.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
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