A Black Triangle symbol is assigned to any drug or vaccine if it meets any of the criteria which is:
a new active substance or a biosimilar medicine
a new combination of medicines or active substances
...
gov.uk/drug-safety-up…
a new active substance or a biosimilar medicine
a new combination of medicines or active substances
...
gov.uk/drug-safety-up…
a new route of administration
a new drug-delivery system
an established medicine which is to be used in a new patient population.
a new drug-delivery system
an established medicine which is to be used in a new patient population.
The MHRA assesses the Black Triangle status of a product usually 2 years after marketing; however, there is no standard time for a product to retain Black Triangle status. The symbol is not removed until the safety of the drug is well established.
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