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A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
Information on practical arrangements for notification, what should and should not be classified as a “serious breach” and what must be reported.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Points to consider when using real-world data in clinical studies
Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.
Reforms to ensure that medical device regulation is fit for purpose for software products, including artificial intelligence (AI).
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Provides a standard framework for NHS procurement professionals to assess non-financial value when buying medical technology.
Requirements and recommendations for sponsors and those conducting trials.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
Which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities.
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.
Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
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