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For manufacturers reporting adverse incidents with joint replacement implants under the vigilance system.
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.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2021.
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)
From discovery to real-world impact, VDEC equips scientists with the expertise and facilities to navigate each step in the development of vaccines and therapeutics.
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.
Guidance for manufacturers on reporting adverse incidents involving breast implants under the vigilance system.
Expansion of extra-jurisdictional inspection outcomes.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
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.
Acceptable naming, presentation and packaging of nicotine-containing electronic cigarettes and refill containers.
UK government interpretation of the requirements for labelling e-liquids for Northern Ireland.
Guidance and specifications for the recording and extraction of CTAD data from laboratories in England processing LA and NHS commissioned chlamydia tests.
Deficiencies in Omega’s pharmacovigilance system are not thought to affect the safety of the products that they market.
The Defence and Security Accelerator (DASA) is running a Market Exploration to explore research and technology development of relevance to the modelling of traumatic wounds and the monitoring of their progression.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Notification Fees for Great Britain and Northern Ireland
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