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Information about the MHRA's duties and how you can report a non-compliant medical device.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Clinical trial applications that need expert advice from a specialist group or committee.
This guidance summarises our approach to pharmacovigilance
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Comply with good pharmacovigilance practice and prepare for an inspection.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
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