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By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
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 to use RamaXL, including system availability, running reports and how to subscribe.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
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