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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)
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
British travellers to the US must register with the Electronic System for Travel Authorisation (ESTA) before their journey
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
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.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How to change the ownership from one marketing authorisation (MA) holder to another.
How to renew marketing authorisations for products granted through different routes and at different times.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Apply for an Academic Technology Approval Scheme (ATAS) certificate, to study certain subjects in the UK.
Find out about the different simplified declarations for imports and what you need to do to get authorisation to use them.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Information on who can get an ETA and how to apply before coming to the UK.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Find out how to use the Online Agent Authorisation to get client authorisation for HMRC online services for agents.
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.
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