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Help improve °Ç¸ç³Ô¹Ï
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 the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
How to renew marketing authorisations for products granted through different routes and at different times.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
How to change the ownership from one marketing authorisation (MA) holder to another.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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.
Guidelines to help mitigate and manage medicine shortages.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information about how approved bodies help regulate medical devices and how to apply for approval.
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…
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 on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
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