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The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
How to apply for marketing authorisation via this new procedure.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
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.
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…
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Information relating to the disapplication of falsified medicines under UK Law.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
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