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A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Apply for and maintain registrations for the brokering of human medicines.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Guidelines to help mitigate and manage medicine shortages.
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
Information for clinicians and patients.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
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