Section 11: Labelling

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;…

All medicinal products are fitted with the tamper-evident device referred to in Article R. 5121-138-2. However, this device is not compulsory for medicinal products on the list set out in Annex I to 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 of medicinal products for human…

The safety features may only be replaced by equivalent safety features in order to verify the authenticity, identify and provide proof of unlawful handling of the medicinal product. This replacement is carried out without opening the immediate packaging as defined in 3° of article R. 5121-1 and in compliance with the good practices mentioned in article L. 5121-5. Safety devices are considered equivalent if : 1° They meet the requirements…

I.- In addition to the company’s distinctive sign, the outer packaging may include signs or pictograms explaining some of the above information, as well as other information compatible with the summary of product characteristics. This information must be useful for patients and must not be promotional in nature. II -When the medicinal product or product has effects on the ability to drive vehicles or use machines, as mentioned in the…

The information provided for in Articles R. 5121-138 and R. 5121-139 is written in French. They may also be written in other languages, provided that the same information appears in all the languages used. When the medicinal product is not intended to be supplied directly to the patient or when it is made available to the patient on an exceptional basis, in particular due to the unavailability of a medicinal…

By way of derogation from the provisions of Article R. 5121-138, when the medicinal products or products are contained in an outer packaging that complies with the requirements of the said Article, the primary packaging in blister pack form must include at least the following information: 1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, the name of the recipient (“infants”, “children”…

Ampoules or other small primary packaging on which it is impossible to include all the information specified in Article R. 5121-138 may bear only the following information: 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”) and, where the medicinal product contains no more than three active substances, the non-proprietary name(s) ; 2°…