Black triangle products
In the European Union (EU), medicines that are being monitored closely by regulatory authorities are labelled with a black inverted triangle (▼) in the product information. These medicines are described as being under ‘additional monitoring’.
Medicines under additional monitoring carry a black triangle symbol (an inverted equilateral black triangle; ▼) to let patients and Health Care Professionals (HCPs) know that these medicines are being closely monitored by European regulatory authorities.
 |
| Black triangle products |
Where this black triangle symbol finds?
The black triangle symbol appears next to the name of relevant medicines on their Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), on educational materials for HCPs and on patient support materials.
(this symbol indicates) This medicinal product is subject to additional monitoring.
Additional monitoring aims to enhance reporting of suspected adverse drug reactions for medicines for which the clinical evidence base is less well developed. The main goals are to collect information as early as possible to further inform the safe and effective use of these medicines and their benefit-risk profile when used in everyday medical practice.
How long this black triangle carries with product?
Typically new medicines are assigned a black triangle for a period of five years following first authorisation in the EU. In some cases the period may be longer than five years.
Role of Pharmacist
Pharmacists should be vigilant and report all suspected adverse drug reactions for black triangle medicines and help support and educate patients with any questions they may have regarding the scheme.
Pharmacists should be familiar with any risk minimisation materials a medicine may have and ensure that they are distributed to patients and that patients are counselled on their use.
Medicines subject to additional monitoring:
Additional monitoring status is always applied to a medicine in the following scenarios:
- It contains a new active substance authorised in the EU after 1 January 2011;
- It is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), authorised in the EU after 1 January 2011;
- It has been given a conditional approval or approved under exceptional circumstances;
- 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;
- It is authorised with specific obligations on the recording of suspected adverse drug reactions.
The European Medicines Agency (EMA) maintains a list of all medicines that are under additional monitoring in the EU. The list of medicines for monitoring is reviewed each month by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) and updated as required.