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Guidance for manufacturers who source their own-branded products from another company.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Notification Fees for Great Britain and Northern Ireland
A 5-year voluntary scheme on the control of prices agreed between government and the Association of the British Pharmaceutical Industry (ABPI).
Poster with advice for healthcare professionals on how to carry out point of care testing safely and correctly.
Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
How to report adverse incidents involving insulin infusion pumps and integrated meter systems under the vigilance system.
Guidance and change control form to request a change to an Advisory Committee on Borderline Substances (ACBS) application form and/or guidance.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2021.
Update about the developing role of biosimilar medicines in the NHS in England and the safe, effective and consistent use of biosimilar medicines.
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.
VDEC’s Discovery and surveillance capabilities provide unique services across a spectrum of molecular immunology platforms.
Actions that trial sponsors should consider to build resilience into clinical trial design
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.
VDEC works with global leaders from all sectors to develop and deliver the vaccine and therapeutic products we need to protect us from infectious diseases.
We use decades of experience in safe bioagent handling to support partners in research, development and testing of vaccines and therapeutics
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
Expansion of extra-jurisdictional inspection outcomes.
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