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Information relating to the disapplication of falsified medicines under UK Law.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to renew marketing authorisations for products granted through different routes and at different times.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
How to change the ownership from one marketing authorisation (MA) holder to another.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Guidelines to help mitigate and manage medicine shortages.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
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.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
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