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The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Links to EU guidance, as it stood immediately before end of transition period.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Apply for and maintain registrations for the brokering of human medicines.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Recommendations for prescribing methadone and buprenorphine to people in treatment for opioid dependence in England.
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
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…
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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 poster explaining the different symbols used on medical devices.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
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