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Guidelines to help mitigate and manage medicine shortages.
How to apply for marketing authorisation via this new procedure.
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).
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
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…
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Industry must notify the MHRA if they will not be using these flexibilities
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
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