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How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
Advice for healthcare professionals when handling oxygen cylinders and their regulators.
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.
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.
Information relating to the disapplication of falsified medicines under UK Law.
How marketing authorisation holders should provide educational materials to MHRA for assessment and approval prior to launching their products on the UK market.
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.
Explains regulations that widen the availability of naloxone, a drug used as an antidote for heroin (or other opiate) overdoses.
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
Guidance for healthcare providers in the UK.
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.
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