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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 to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Industry must notify the MHRA if they will not be using these flexibilities
How to use RamaXL, including system availability, running reports and how to subscribe.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
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 whether or not your product is a medical device.
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access p…
The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs)
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The way you apply to licence biological products has changed
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
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
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Information relating to the disapplication of falsified medicines under UK Law.
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
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