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Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
MHRA's Improving Patient Information project aims to modernise how medicines product information is delivered, making it more accessible, trusted, and future-ready.
Guidance on clinical trials that are categorised as ‘notifiable’.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Detailed guidance on advertising and promoting medicines.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.
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.
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