Medicines and Healthcare products Regulatory Agency (MHRA)
Guidance on how to get an e-cigarette on the market in the UK, including the notification scheme and reporting problems with e-cigarettes.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to contact MHRA for specific services or enquiries.
What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Information about the risks of taking valproate medicines during pregnancy.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to license a medicine for sale in the UK and Europe, including applications through national, centralised and decentralised procedures.
How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.
How to prepare for implementation and compliance of the Safety Features Regulation.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to conform with the legal requirements for placing medical devices on the market.
What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal.
Details of the Yellow Card Scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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