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This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
How the MHRA processes variations to Marketing Authorisations (MAs)
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
Follow this guidance when you want to get spend approval for commercial activities costing £20 million or more excluding VAT.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How the Northern Ireland Protocol affects supplementary protection certificates (SPCs), and what it means you need to do when applying for an SPC and afterwards.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Authorisation decisions on the time-limited use of hazardous substances of very high concern under UK REACH.
How to renew marketing authorisations for products granted through different routes and at different times.
Follow this guidance when you want to get spend approval for digital and technology activities.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to apply for funding for plug-in vehicles as a car manufacturer or dealership.
Find out what you need to do to apply for temporary approval if your approval has been rejected or revoked in one of the application schemes.
Check if an inward or outward processing authorisation requires an economic test to test the impact the authorisation holder's goods have on UK producers.
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.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Apply for an Academic Technology Approval Scheme (ATAS) certificate, to study certain subjects in the UK.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to change the ownership from one marketing authorisation (MA) holder to another.
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