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Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
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.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
This guidance is designed to provide information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
The call for applications for phase 2 of the AI Airlock is now closed.
Labelling requirements for e-liquids.
Guidance and advice for community pharmacies in England providing services to people who use drugs and alcohol.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Dear colleague letter from Barry Cockcroft, Chief Dental Officer, dated 24 March 2011. Download :National Institute for Health and Clinical…
Explainer for industry on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
Industry must notify the MHRA if they will not be using these flexibilities
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
The pre-clinical evaluation team at VDEC provides a safe and controlled environment to test new vaccines and therapeutics before they progress to clinical trials
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Guidance for hospital blood banks on issuing blood components electronically in line with best practice.
Don’t include personal or financial information like your National Insurance number or credit card details.
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