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A list of authorised orphan medicinal products registered by the UK licensing authority.
Orphan registered products are listed in alphabetical order by trade name.…
A list of orphan authorisations previously registered by the UK Licensing…
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
A list of authorised CAP Bridging Mechanism products registered by the UK Licensing Authority.
CAP Bridging Mechanism products are listed in alphabetical order by trade…
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to prepare for implementation and compliance of the Safety Features Regulation.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
Department of Health and Social Care and MHRA register of electronic export certificates (human).
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Guidance on measures in place until the Windsor Framework takes effect on 1 January 2025.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How to change the ownership from one marketing authorisation (MA) holder to another.
Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
Pfizer Ltd are recalling all in-date batches of Champix (varenicline) as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake. This recall also includes Parallel Imp…
Advanced Accelerator Applications (UK & Ireland) Ltd is recalling a specific batch as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.
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