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Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.
This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Information for patients who have been prescribed Paxlovid (nirmatrelvir 150mg and ritonavir 100mg) film-coated tablets COVID-19 antiviral medication.
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
The MHRA has published advice for patients and healthcare professionals
Guidance on measures in place until the Windsor Framework takes effect on 1 January 2025.
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
Information relating to the disapplication of falsified medicines under UK Law.
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
Advice on ingredients in nicotine-containing liquids in electronic cigarettes and refill containers.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Deficiencies in Omega’s pharmacovigilance system are not thought to affect the safety of the products that they market.
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
The review of the safety of isotretinoin has concluded.
UK government interpretation of the requirements for labelling e-liquids for Great Britain
What 'single-use' means and what symbol is used by manufacturers to show this.
General advice on vigilance - electronic cigarettes devices and refill containers.
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