Black Triangle: a New EU Requirement

In the future, following an Implementing Regulation adopted by the European legislator, medicinal products with new APIs shall be subject to additional monitoring. This should help improve medicinal products safety (pharmacovigilance).

The medicinal products in question should bear a warning symbol: the black triangle.

The symbol is black and has the shape of an inverted triangle. It is supposed to be proportional to the font size of the subsequent standardised text; however, each side of the triangle has to have a minimum length of 5 mm.

The presence of the warning symbol should point out the fact that the medicinal product is subject to additional monitoring.

The symbol will have to appear on all the medicinal products concerned which will be manufactured after 1st January 2014. It comprises all medicinal products authorised in the EU that contain a new API which hadn't been contained in any medicinal product on 1st January 2011 as well as biological medicinal products authorised after 1 January 2011 - particularly "biosimilars".

More information can be found on the European Commission's Website and at ECA's Conference on Printed Packaging Materials, where Dr Klaus Menges from the BfArM will present these new requirements.

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