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How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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 show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
A guide to the legislation enabling drug services and others to supply take home naloxone without a prescription to save a life in an emergency.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
How to contact the MHRA for specific services or enquiries.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
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