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Black Triangle Scheme (â–¼) 

The Black Triangle Scheme was introduced in the UK as part of the 2010 pharmacovigilance legislation, which came into effect in July 2012. The black triangle symbol began appearing in the package leaflets of affected medicines in autumn 2013. Black Triangle (â–¼) became a part of an European Union (EU) wide scheme in 2013.

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The Black Triangle Scheme is a visual reminder to encourage patients and health practitioners to report any side effects or problems. The scheme applies to medicines that require additional monitoring, including:

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  • Medicines that contain a new active substance

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  • Biological medicines, such as vaccines or those derived from blood

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  • Medicines that have been given conditional approval

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  • Medicines that require further studies

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When a medicine carries a Black Triangle (â–¼), this means that it is subject to intensive monitoring. The Medicines and Healthcare products Regulatory Agency is particularly interested in hearing about any suspected adverse reactions associated with these medicines. You and healthcare professionals can report online at www.mhra.gov.uk/yellowcard.

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Medicines will be typically assigned a Black Triangle for a period of five years. The black triangle is usually removed once the product's safety has been assessed and proven. However, there is no specific limit on how long a product retains its black triangle status. Regulators may request that a medicine continue to have a black triangle for a longer period of time.

Vaccines on the August 2024 Black Triangle List and reason(s) for their inclusion on the list

Please note that a Black Triangle (additional monitoring status) is always assigned to a medicine if:

 

  • it contains a new active substance; new medicines or vaccines authorised on or after January 2011 are assigned a Black Triangle

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  • it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood)

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  • it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data) 

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  • the company that markets the medicine is required to carry out additional studies: for instance, to provide more data on long-term use of the medicine, or on a rare side effect seen during clinical trials.

Vaccines on the August 2024 Black Triangle List and reason(s) for their inclusion on the l
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