MHRA yellow card

From Safer nicotine wiki

The MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that healthcare products meet appropriate standards of safety, quality and efficacy. We keep watch over medicines and devices, and take necessary action to protect the public promptly if there is a problem.

Speak to your doctor, pharmacist or to call [111] if you are worried about your health as the MHRA is unable to provide medical advice.

The Yellow Card scheme

The MHRA runs the Yellow Card scheme, which collects and monitors information on suspected safety concerns involving a healthcare products, like a side effect with a medicine or an adverse medical device incident. The scheme relies on voluntary reporting of problems to a healthcare product by the public (including patients, parents and carer givers) as well as from healthcare professionals. The scheme also collects suspected safety concerns involving defective (not of an acceptable quality), falsified or fake healthcare products.

Healthcare products

Always read the patient information leaflet, or instructions supplied with your medicine or medical device. It lists the known side effects or problems and advises you on what to do. You can report safety issues from any healthcare product to the Yellow Card scheme. Healthcare products include:

  • Medicines
  • Vaccines
  • Blood factor and immunoglobulin products
  • Herbal products or complementary therapies such as homeopathies
  • Medical devices (including software, apps and artificial intelligence)
  • E-cigarettes including their refill containers (e-liquids)

More information on the types of reports for these healthcare products can be found here.

Aims of the scheme

It is important for people to report problems experienced with healthcare products as these are used to identify issues which might not have been previously known about. The purpose of the Yellow Card scheme is to provide an early warning that the safety of a product may require more further investigation. The scheme helps the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users. Reports are used alongside other safety information and help the MHRA to take action if any trends associated to the safety or efficacy of a healthcare product are identified. The MHRA will review the issue and if necessary, take action to minimise risk and maximise benefit to the patients.

Latest details on E-Cigarettes

Report on all adverse events reported by the yellow card scheme
Report on all adverse events reported by the yellow card scheme
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