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Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2025.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Information on how to request assistance from the NSDR.
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
The MHRA's initial plans on an Early Access service, which will be developed further throughout 2025.
A poster explaining the different symbols used on medical devices.
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…
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
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