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Advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.
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.
Information for pharmaceutical wholesalers explaining the main changes the Windsor Framework introduces to the packaging for all medicines licensed in the UK, effective from 1 January 2025.
Find out about coronavirus (COVID-19) treatments available outside of hospital, including information on free prescriptions and lateral flow tests.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
VDEC’s Discovery and surveillance capabilities provide unique services across a spectrum of molecular immunology platforms.
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
Information for retailers from Great Britain supplying medical devices to Northern Ireland.
Industry must notify the MHRA if they will not be using these flexibilities
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
We use decades of experience in safe bioagent handling to support partners in research, development and testing of vaccines and therapeutics
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
Submitting annual reports on sales of electronic cigarettes and refill containers.
Personal protective equipment for sale by the Department of Health and Social Care (DHSC) including visors, gowns, aprons and goggles.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
Information for local authorities in England about the grant, which will support local authorities to deliver routine commissioning of PrEP in 2020 to 2021.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
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