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Departments, agencies and public bodies
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Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025.
Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.
Our Patient Involvement Strategy sets out how we will engage and involve the public and patients at every step of the regulatory journey.
Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.
For manufacturers reporting adverse incidents with joint replacement implants under the vigilance system.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2023.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2020.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2021.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.
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.
Guidance for manufacturers on reporting adverse incidents involving breast implants under the vigilance system.
Expansion of extra-jurisdictional inspection outcomes.
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
Guidance and specifications for the recording and extraction of CTAD data from laboratories in England processing LA and NHS commissioned chlamydia tests.
Sets out opportunities for commissioners and providers to realise community pharmacy’s role in protecting and improving the nation's health.
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