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News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched …
Apply for and maintain registrations for the brokering of human medicines.
Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Information for clinicians and patients.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
Guidelines to help mitigate and manage medicine shortages.
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
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.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
A list of herbal ingredients that are banned or restricted for unlicensed medicines.
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