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The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
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 on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Using an ecological momentary assessment to evaluate your digital health product.
Submission dates and how the submissions using the EC decision reliance procedure work.
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.
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