French Public Health Code
In forceI.-The labelling of the medicinal products mentioned in 1° of II of article L. 5121-12 includes at least the following information:
1° The name of the medicinal product or, where appropriate, its code name or international non-proprietary name;
2° The name or corporate name and address of the company manufacturing the medicinal product;
3° The batch number;
4° The route and, if applicable, the method of administration of the medicinal product;
5° The composition in terms of active ingredients and excipients with a known effect;
6° The expiry date;
7° Where appropriate, any information required for the proper storage of the medicinal product.
The above information is written in French. They may also be written in other languages, provided that the same information appears in all the languages used.
Where the medicinal product is not intended to be supplied directly to the patient or where the medicinal product complying with these provisions is not immediately available when authorisation is granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at the justified request of the holder of the marketing rights or his authorised representative and subject to the measures he deems necessary to protect human health, waive the obligation to include certain particulars and to draft the particulars in French for a period specified in the notice referred to in III of Article L. 5121-12. 5121-12.
II.-The labelling and package leaflet of the medicinal products mentioned in 2° of II of article L. 5121-12 are defined in accordance with their marketing authorisation and in accordance with the provisions mentioned in articles R. 5121-138 and R. 5121-149.
III.For a medicinal product which has been the subject of an early access authorisation prior to its marketing authorisation, the holder of the early access authorisation has a maximum period of three months from the date of issue of the marketing authorisation, unless an exception is granted in accordance with the conditions set out in 4° of II of article R. 5121-72, to make the medicinal product available with labelling and a package leaflet that comply with its marketing authorisation and the provisions mentioned in Article R. 5121-138 and Article R. 5121-149.
