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Information on how to request assistance from the NSDR.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
A poster explaining the different symbols used on medical devices.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Instructions for integrating with the new production MORE platform API.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
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.
A user guide for understanding and applying the national taxonomy for incident learning in clinical imaging, magnetic resonance imaging and nuclear medicine.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Information and recommendations for manufacturers on the preparation and presentation of a post-market surveillance report (PMSR).
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
VDEC responds strategically to AMR pathogens and new emerging threats (fungi, viruses, and bacteria), by determining the most appropriate research goals to combat these pathogens
Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.
Information relating to parallel imports and the implementation of the Windsor Framework.
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, …
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
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