May 18, 2018
Subgroup of common visual reminder (boxed warning and pictogram) to warn patient about teratogenic or foetotoxic effect on Baltic Package agreed upon the following common pictogram and its layout
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.
In order to ensure a harmonised risk communication for patients in Latvia, the State Agency of Medicines invites all Marketing authorisation holders of the relevant medicinal products registered in national, decentralised and mutual recognition procedures to use the same visual reminder as recommended for the Baltic Package on the outer packaging of their represented medicinal products.
