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Explainer for industry on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
Guidance and advice for community pharmacies in England providing services to people who use drugs and alcohol.
Scientific advice queries on nanomedicines have increased in recent years, particularly on lipid nanoparticles.
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Guidance for local partnerships on how to review adult drug and alcohol related deaths and near-fatal overdoses to prevent future deaths.
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 for healthcare professionals on risk minimisation options for medicines.
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
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
Information on how to request assistance from the NSDR.
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.
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
Acceptable naming, presentation and packaging of nicotine-containing electronic cigarettes and refill containers.
Don’t include personal or financial information like your National Insurance number or credit card details.
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