2016/0635/F
EC/EFTA
FR Frankreich
  • C00P - PHARMAZEUTIKA, KOSMETIKA
2016-12-15
2016-12-13

Medicinal product for human use

Order issued pursuant to Article R. 5121-139 of the French Public Health Code and relating to the placement of a pictogram on the outer packaging of certain medicines or products

This draft order determines the templates for the three pictograms that should be placed on the outer packaging of medicinal products that have teratogenic or foetotoxic effects, and of medicinal products containing sodium valproate or its derivatives, depending on the circumstances.

The first pictogram warns patients about medicinal products that it is advisable not to use during pregnancy unless no alternative therapy is available.

This pictogram consists of a red equilateral triangle with sides of at least one centimetre on a white background, containing an image of a pregnant woman in black. To the right of this, or below it, the following wording appears: ‘NOM DE LA SPECIALITE + GROSSESSE = DANGER’ [‘NAME OF THE PROPRIETARY MEDICINAL PRODUCT + PREGNANCY = DANGER’]. Below it is the following message: ‘Ne pas utiliser chez les adolescentes ou femmes en âge de procréer et sans contraception efficace, ou enceintes, sauf en l’absence d’alternative thérapeutique’ [‘Not to be used by adolescents or women of childbearing age not using effective contraception or already pregnant, unless no alternative therapy is available’].

The second pictogram warns patients about medicinal products that are contraindicated during pregnancy and which they should not use.

This pictogram is a crossed-through red circle on a white background, at least a centimetre in diameter, containing an image of a pregnant woman in black. To the right of this, or below it, the following wording appears: ‘NOM DE LA SPECIALITE + GROSSESSE = INTERDIT’ [‘NAME OF THE PROPRIETARY MEDICINAL PRODUCT + PREGNANCY = FORBIDDEN’]. Below it is the following message: ‘Ne pas utiliser chez les adolescentes ou femmes en âge de procréer et sans contraception efficace, ou enceintes’ [‘Not to be used by adolescents or women of childbearing age not using effective contraception or already pregnant’].

The third pictogram warns patients about medicinal products containing valproate or its derivatives, which it is advisable not to use during pregnancy unless other treatments have failed.

This pictogram consists of a red equilateral triangle with sides of at least one centimetre on a white background, containing an image of a pregnant woman in black. To the right of this, or below it, the following wording appears: ‘NOM DE LA SPECIALITE + GROSSESSE = DANGER’ [‘NAME OF THE PROPRIETARY MEDICINAL PRODUCT + PREGNANCY = DANGER’]. Below it is the following message: ‘Ne pas utiliser chez les filles, adolescentes ou femmes en âge de procréer ou enceintes, sauf en cas d’échec des autres traitements’ [‘Not to be used by girls, adolescents or women of childbearing age, or who are pregnant, unless other treatments have failed’].