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Data, Freedom of Information releases and corporate reports
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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.
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.
Guidance on categorising certain clinical trials as ‘notifiable’.
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 MHRA’s national assessment procedure for marketing authorisation applications.
You must get permission to export certain drugs and medicines.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Clinical trial applications that need expert advice from a specialist group or committee.
Guidance on the process for ending a clinical trial.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Fees payable to the MHRA from 2025.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
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