Medicinal product for human use
Decree on the placement of a pictogram on the outer packaging of certain medicines or products
The draft decree on the placement of a pictogram on the outer packaging of certain medicines or products is issued pursuant to Article L5121-20 of the French Public Health Code. This provision stems from Article 62 of Directive 2001/83/EC, which provides that the outer packaging of medicinal products may include pictograms designed to clarify certain information compatible with the summary of the product characteristics for the patient.
The main purpose of this draft decree is to display a pictogram on the outer packaging of medicinal products or products having teratogenic or foetotoxic effects, when this is mentioned in the marketing authorisation (MA). The pictogram templates shall be determined by Order of the Minister for Health on the advice of the Director General of the French National Agency for the Safety of Medicine and Health Products (ANSM). The pictograms can only be used in respect of medicinal products for which an MA has been issued under a mutual recognition procedure, a decentralised procedure or under a national procedure. Pharmaceutical laboratories affected by this provision must send ANSM for information purposes a sample copy of the outside packaging bearing the pictogram. Pharmaceutical laboratories shall have three months from the publication of the order establishing these pictogram templates to apply this provision. If the above provisions are not complied with, the Director-General of ANSM may suspend the MA of the medicinal product in question.