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How to change the ownership from one marketing authorisation (MA) holder to another.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to renew marketing authorisations for products granted through different routes and at different times.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.
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.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
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.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
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