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How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Guidance on transitional arrangements for the Clinical Trials Regulations.
How to conform with the legal requirements for placing medical devices on the market.
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.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
The review of the safety of isotretinoin has concluded.
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'
How to get access to MHRA submissions portals, how to use them, where to go for help.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.
Guidance on using non-investigational medicinal products in a clinical trial.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
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