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How to renew marketing authorisations for products granted through different routes and at different times.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
This strategy sets out our vision of the role of the retail market in achieving net zero.
How to set up a public service mutual and 'spin out' of a public service organisation.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
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.
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
The effectiveness of marketing channel liberalization in increasing competition among traders and prices obtained by farmers for their produce
From 13 May 2024 we are introducing a change to the procedure for new Marketing Authorisation (MA) applications, where a joint assessment of labels is requested.
How to apply for marketing authorisation via this new procedure.
Marketing authorisations granted in 2024
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
RIDA funds research and development in new technologies, and new approaches to existing technologies, that support Sustainable Development Goals in south-east Asia.
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