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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 register your medical devices with the Medicines and Healthcare products Regulatory Agency (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.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Information about the risks of taking valproate medicines during pregnancy.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
How to contact MHRA for specific services or enquiries.
The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.
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