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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 on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
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…
How the MHRA treats traditional herbal medicines and homeopathic medicines.
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 approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Information relating to the disapplication of falsified medicines under UK Law.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
How to use RamaXL, including system availability, running reports and how to subscribe.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Industry must notify the MHRA if they will not be using these flexibilities
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
AI Airlock programme develops industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
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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