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How to change the ownership from one marketing authorisation (MA) holder to another.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
How to renew marketing authorisations for products granted through different routes and at different times.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
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 identify and, if found, 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.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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 locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Guidelines to help mitigate and manage medicine shortages.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
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