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Information about suspected side effects of e-cigarettes and how to report side effects.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Overview of the different types of MHRA safety communications about medicines, medical devices and other healthcare products, including what they are and who they are aimed at, and information on decision-making around safet…
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
Under some circumstances (clarified in this statement), the CMA will not prioritise enforcement action against competing drug firms in relation to commercial negotiations to make combination therapies available to patients, …
A user guide for understanding and applying the national taxonomy for incident learning in clinical imaging, magnetic resonance imaging and nuclear medicine.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Guidance on registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity.
Information on how to request assistance from the NSDR.
The MHRA’s Innovation Office offers access to expert regulatory guidance for developers of innovative medicines and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulat…
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
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