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Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
A 5-year voluntary scheme on the control of prices agreed between government and the Association of the British Pharmaceutical Industry (ABPI).
How to report adverse incidents involving insulin infusion pumps and integrated meter systems under the vigilance system.
For manufacturers reporting adverse incidents with joint replacement implants under the vigilance system.
Outlines the aim, scope and definitions of the medical technology innovation classification framework.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
Notification Fees for Great Britain and Northern Ireland
Directions setting out the integration of the Ministry of Defence (MoD) into the NHS Prescription Service.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Information relating to the disapplication of falsified medicines under UK Law.
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.
UK government interpretation of the requirements for labelling e-liquids for Northern Ireland.
Submitting notifications on the European common entry gate for Northern Ireland for suppliers of e-cigarettes and e-liquids.
Collecting and acting on information on any adverse effects of electronic cigarette devices and refill containers on human health.
General advice on vigilance - electronic cigarettes devices and refill containers.
Information for local authorities in England about the grant, which will support local authorities to deliver routine commissioning of PrEP in 2020 to 2021.
Guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs).
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
AI Airlock programme develops industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
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