The Medicines and Healthcare Products Regulatory Agency (MHRA)
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.
The MHRA 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 – a scheme 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.
To see information about this go here: http://www.mhra.gov.uk/spc-pil/?indexChar=X#retainDisplay
For more information about the MHRA go to:
The Yellow Card Scheme
The Yellow Card Scheme is vital in helping the Medicines and Healthcare products Regulatory Agency (MHRA) to monitor the safety of the medicines and medical devices that are on the market.
Anyone, not just a clinician, can report suspected side effects (also known as adverse drug reactions) to a medicine, vaccine, herbal or complementary remedy or an adverse incident in respect of a medical device if:
- a medicine causes side effects
- someone’s injured (or almost injured) by a medical device, either because its labelling or instructions aren’t clear, it’s broken or has been misused
- a patient’s treatment is interrupted because of a faulty device
- someone receives the wrong diagnosis because of a medical device
- a medicine doesn’t work properly
- a medicine is of a poor quality
- you think a medicine or medical device is fake or counterfeit
Once a report is received the problem will be investigated by the MHRA, the manufacturer or a medical specialist, depending on how serious it is. Even if it is not investigated, it will be recorded to help prevent similar incidents in future.
You will receive a confirmation of your report and if you need to give more information, they will contact you.
Thyroid UK believes that any side effects to a thyroid hormone medicine should be reported.
For more information about the Yellow Card Scheme go to: https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
To report a medicine or medical device go to: https://yellowcard.mhra.gov.uk/
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Date created: 03/06/19 (V2.0)
Review date: 03/06/20