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Information relating to parallel imports and the implementation of the Windsor Framework.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Under some circumstances (clarified in this statement), the CMA will not prioritise enforcement action against competing drug firms in relation to commercial negotiations to make combination therapies available to patients, …
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
The Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
Overview of the different types of MHRA safety communications about medicines, medical devices and other healthcare products, including what they are and who they are aimed at, and information on decision-making around safet…
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
Links to EU guidance, as it stood immediately before end of transition period.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
An initiative to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to m…
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
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