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Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
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.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without an authorisation.
Register as a manufacturer, importer or distributor of active substances.
A collection of active marine guidance notes, published by the Maritime and Coastguard Agency (MCA).
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