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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to manage and use bed rails safely.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
How to contact the MHRA for specific services or enquiries.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to get access to MHRA submissions portals, how to use them, where to go for help.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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