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Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland.
Under some circumstances (clarified in this statement), the CMA will not prioritise enforcement action against competing drug firms in relation to commercial negotiations to make combination therapies available to patients, …
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Information about suspected side effects of e-cigarettes and how to report side effects.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS).
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
A user guide for understanding and applying the national taxonomy for incident learning in clinical imaging, magnetic resonance imaging and nuclear medicine.
Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system.
Checklists providing a practical guide to using medical devices in a range of healthcare settings.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Update on MHRA UK risk-based GxP inspection programme.
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