The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health and is responsible for:
- ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy
- ensuring that the supply chain for medicines, medical devices and blood components is safe and secure
- promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
- helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- supporting innovation and research and development that’s beneficial to public health
- influencing UK, EU and international regulatory frameworks so that they’re risk-proportionate and effective at protecting public health
The MHRA deal with the Yellow Card Scheme which enables you to report problems with a medicine or a medical device (adverse incident).
They also have details of all active substances within medicines along with its patient information leaflet (PIL), which provides information on using the medicine safely and the Summaries of Product Characteristics (SPCs) which are a description of a medicinal product’s properties and the conditions attached to its use.
Date updated: 10.05.21 (V1.2)
Review date: 17.05.22