Company code 191351864
Žirmūnų str. 139A, Vilnius, Lithuania
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65

The additional risk minimisation measure for medicinal products

During the Baltic Meeting held on 10th May 2018 in Tartu (Estonia) there was a discussion of Subgroup of common visual reminder (boxed warning and pictogram) to warn patient about teratogenic or foetotoxic effect on Baltic Package. The use, location and layout of the pictogram, also boxed warning issues were agreed.

For medicinal products where a visual reminder on the outer package to warn patient about teratogenic or foetotoxic effect has been requested as part of additional risk minimisation measure, the pictogram and the boxed warning must be placed on a dedicated surface of the outer packaging bearing no other labelling. Text in boxed warning must contain same languages as on the labelling. Boxed warning and pictogram must be placed side by side.

The pictogram must take the form of a red triangle on a white background, at least a centimetre in diameter, containing an image of a pregnant woman in black. The dimensions of the pictogram, which must be legible, shall be adapted to the size of the outer packaging of the medicinal product.

The use of common pictogram has been agreed by Estonian, Latvian and Lithuanian agencies.