Subsection 1: General provisions.

Without prejudice to the information required by other legislative and regulatory provisions, the labelling of the outer packaging or, where there is no outer packaging, the labelling of the immediate packaging of a medicinal product or a product referred to in Article L. 5121-8, must include the following information, written in such a way as to be easily legible, clearly understandable and indelible:

1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, a reference to the recipient ("infants", "children" or "adults"), as well as, where the medicinal product contains a maximum of three active substances, the non-proprietary name or names; the procedures for writing the name and strength in Braille, as well as the procedures for informing the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) in connection with this writing, are laid down by decision of the Director General of the Agency.

2° The qualitative and quantitative composition in active substances per dosage unit or, depending on the form of administration, for a given volume or weight, using the common names;

3° The pharmaceutical form and content by weight, volume or units of administration;

4° The list of excipients with a known action or effect. However, in the case of an injectable product, a topical preparation or an eye drop, all the excipients are mentioned;

5° The method of administration and, if necessary, the route of administration, followed by a space to indicate the prescribed dosage;

6° A special warning that this medicinal product must be kept out of the reach and sight of children;

7° A special warning, if one is required for this medicinal product;

8° The batch number;

9° The expiry date in clear text;

10° Special storage precautions, if any;

11° Special precautions for disposal of unused products or waste derived from these products, if applicable, and a reference to any appropriate collection system in place;

12° The name and address of the marketing authorisation holder and, where applicable, of the company exploiting the medicinal product or product;

13° The words: "Authorised medicinal product No." followed by the national number identifying the presentation of the medicinal product referred to in article R. 5121-4;

14° For medicinal products not subject to prescription, the therapeutic indication;

15° (Repealed) ;

16° (Repealed) ;

17° The prescription and dispensing classification of the medicinal product, as mentioned in the marketing authorisation;

18° For the homeopathic medicinal products mentioned in 5° of article R. 5121-28 the words: "Homeopathic medicinal product traditionally used in" followed by the therapeutic indication.