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The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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…
Guidance on whether or not your product is a medical device.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Guidelines to help mitigate and manage medicine shortages.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
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.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
The way you apply to licence biological products has changed
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
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