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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 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
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
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.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
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…
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Guidelines to help mitigate and manage medicine shortages.
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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