Chapter I: General provisions

When a medicinal product is the subject of a marketing authorisation granted by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the labelling of its outer packaging or, if there is no outer packaging,…

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…

Medicinal products subject to compulsory prescription shall be provided with the unique identifier referred to in Article R. 5121-138-2, unless they are exempt from this requirement due to their presence on the list established in Annex I of Commission Delegated Regulation No 2016/161 EU of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules concerning safety features on the packaging…

I.-The outer packaging or, where there is no outer packaging, the immediate packaging of medicinal products bears safety features consisting of a unique identifier and a tamper-evident device, under the conditions set out in articles R. 5121-138-1 and R. 5121-138-3. II.-The unique identifier allows persons whose activity is the wholesale distribution of medicinal products or the retail dispensing of medicinal products: 1° To verify the authenticity of the medicinal product;…