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Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
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
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
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.
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Submissions related to human medicines need to be submitted directly to the MHRA.
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Information about the risks of taking valproate medicines during pregnancy.
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