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Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
A summary of actions related to problems with T34 syringe drivers
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
How investigators and sponsors should manage clinical trials during COVID-19
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
The MHRA's initial plans on an Early Access service, which will be developed further throughout 2025.
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
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…
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