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Information for retailers from Great Britain supplying medical devices to Northern Ireland.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
UKHSA offers a unique opportunity to harness world-class intellectual, scientific, and operational expertise for public health solutions.
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
A 5-year voluntary scheme on the control of prices agreed between government and the Association of the British Pharmaceutical Industry (ABPI).
We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
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.
Guidance and specifications for the recording and extraction of CTAD data from laboratories in England processing local authority and NHS commissioned chlamydia tests.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition
A series of webinars providing guidance on the Windsor Framework agreement and 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 2023.
Patient factsheet to provide information on vaccines and vaccine safety.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
VDEC provides a number of services for vaccines post-licensure
Guidance for industry on flexible approaches we are taking on good distribution practices.
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
Actions that trial sponsors should consider to build resilience into clinical trial design
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