A black triangle appearing after the trade name of a British
medicine
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pract ...
(or
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
) indicates that the medication is new to the market, or that an existing medicine (or vaccine) is being used for a new reason or by a new route of administration.
Yellow Card Scheme
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Examples of how it might appear:
*NewDrugTradeName▼
*NewDrugTradeName▼
The black triangle also highlights the need for surveillance of any Adverse Drug Reactions
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...
(ADRs) that might arise from the use of a new medication. The Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
(MHRA) encourage anyone to voluntarily report ADRs (however minor) via the Yellow Card Scheme
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
History ...
to gather more information and gain more understanding of a new medication.
After a new medicine (or vaccine) has been brought to the market there is still a lot that can be learned about the drug from its widespread use. Similarly, if an existing drug is being used in a situation where it was not used before or if it is being given by a different route of administration much can still be learned about its new or modified use.
The black triangle label generally stays with the new drug (or new use of an existing drug) for at least 5 years, when it is reviewed, and after this time the black triangle label may or may not be discontinued.
See also
*Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025)
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...
*EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...
*Uppsala Monitoring Centre
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member c ...
(WHO)
*British National Formulary
The ''British National Formulary'' (BNF) is a United Kingdom (UK) pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicine ...
References
{{reflist
Pharmaceutical industry
Pharmacy in the United Kingdom
ru:Чёрный треугольник