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We are allowing alternative courses of actions for manufacturing or laboratory equipment during the outbreak.
Guidance on the submission and content of notifications for Northern Ireland
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2021.
Expansion of extra-jurisdictional inspection outcomes.
Information on how the ACBS factors in the issue of pricing, when reviewing product applications.
A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
Outcomes from the first meeting with the regulators of medicine who had met globally to discuss dementia.
Report on how community pharmacies can improve the prevention, early detection and management of blood pressure.
Information on medical facilities available in Timor-Leste.
Outlines the level of payment due from members of the Pharmaceutical Price Regulation Scheme (PPRS) in 2018.
A letter providing guidance on the post-transition conversion process was sent by email on 23 October 2020 to the Community MA holders.
Information for healthcare professionals, patients, and the public.
Guidance and change control form to request a change to an Advisory Committee on Borderline Substances (ACBS) application form and/or guidance.
Scientific advice queries on nanomedicines have increased in recent years, particularly on lipid nanoparticles.
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.
How equipment for temperature screening is regulated, the limitations of temperature screening for detecting COVID-19 and advice on buying and using these products.
UK businesses can apply for a share of up to £8 million from the Industrial Strategy Challenge Fund for capital projects to improve medicines manufacturing.
Data submission requirements for acute, community and private microbiology services submitting data on all LA/NHS chlamydia tests done in England.
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