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Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
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.
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
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
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
How to change the ownership from one marketing authorisation (MA) holder to another.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Guidelines to help mitigate and manage medicine shortages.
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.
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)
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 conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
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