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Health watchdogs and authorities

Medicines and Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the government agency which ensures that medicines and medical devices work, and are acceptably safe. The MHRA has three centres, which include the National Institute for Biological Standards and Control (NIBSC), and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.

NHS Choices works closely with the MHRA for all medicines-related information on the website, including providing direct access to the Yellow Cards Scheme from numerous articles. The scheme allows you to report side effects of medicines, as well as incidents and problems with healthcare products. This includes adverse incidents involving medical devices, defective medicines (those that are not of an acceptable quality) and counterfeit (fake) medicines or medical devices. See Reporting an adverse effect below.

 

MHRA's key responsibilities

  • To assess the safety, quality and effectiveness of medicines, including to authorise their sale or supply in the UK for human use.
  • To operate rigorous surveillance and inspection systems for the investigation of adverse reactions to medicines (the Yellow Card Scheme) and to adverse incidents involving medical devices, taking any necessary action to safeguard public health.
  • To operate a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines, and investigating internet sales and potential counterfeiting of medicines.
  • To regulate clinical trials of medicines and medical devices.
  • To monitor and ensure compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary.
  • To promote good practice in the safe use of medicines and medical devices.
  • To provide the public and professions with authoritative information on treatment choices

For more detailed information, visit the MHRA website.

 

Reporting an adverse effect

The Yellow Card Scheme is a special reporting system for possible adverse effects of medicines. If the healthcare professional treating you thinks a medicine may have caused a potentially negative effect, they will fill in a report and send it to the MHRA.

It is important to report problems with medicine or medical devices, to identify issues which may not have been known previously. The MHRA will review the product if necessary, and take action to minimise risk and maximise benefit to the patients. The MHRA is also able to investigate counterfeit or fake medicines or devices and, if necessary, take action to protect public health. You can use the Yellow Card Scheme yourself, or on behalf of a child or adult in your care.

You can make a report by:

  • Accessing the Yellow Card Scheme website.
  • Phoning 0808 100 3352.
  • Posting a Yellow Card form. You can download the form online or ask your pharmacist for one.
  • Use the free Yellow Card App. The app is available on iTunes or GooglePlay. The app will allow you to create a "watch list" for medicines. You’ll then get official news and alerts about those medicines, be able to view the number of Yellow Cards received by the MHRA, and see previous Yellow Cards you have submitted through the app.

Page last reviewed: 24/03/2016

Next review due: 24/03/2018

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