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What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
How to change the ownership from one marketing authorisation (MA) holder to another.
How to renew marketing authorisations for products granted through different routes and at different times.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
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.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Guidelines to help mitigate and manage medicine shortages.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
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