Title II: Medicinal products for human use

The importation of a proprietary medicinal product constitutes a parallel import with a view to placing it on the market in France: 1° Which comes from another Member State of the European Community or party to the Agreement on the European Economic Area, in which it has obtained a marketing authorisation; 2° Whose quantitative and qualitative composition in terms of active substances and excipients, pharmaceutical form and therapeutic effects are…

Except where there are public health reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an authorised company within the meaning of Article 77 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; 2° The batches of this…

The proprietary medicinal product for which parallel import authorisation is sought may differ from the proprietary medicinal product which has already obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than those of the proprietary medicinal product which has obtained marketing authorisation in France; 2° Size, shape, colour, engraving, printing or any other marking; 3° The composition of the excipients;…

The labelling and outer packaging of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained marketing authorisation in France, except in that they include : 1° The addition, in addition to the information provided for in Article R. 5121-138, of the name and address of the establishment responsible for modifying the packaging ; 2° The parallel import…

The package leaflet of the proprietary medicinal product benefiting from a parallel import authorisation is identical to that of the proprietary medicinal product which has obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsible for changing the packaging, in addition to the information provided for in e of 1° of Article R. 5121-149; 2° The full qualitative…

The application for parallel import authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate name and address of the applicant ; 2° Concerning the proprietary medicinal product which has obtained marketing authorisation in France: its name, strength, pharmaceutical form and qualitative and quantitative composition in active substances; 3° With regard…

The application for a parallel import authorisation is accompanied by a dossier comprising : 1° A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intended to be imported into France; 2° A copy of the authorisation to open the establishment authorised within the meaning of Article 40 of Directive…

If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent for a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel import will be refused. This time limit is extended by fifteen days if the Director General of the Agency requests additional…

The parallel import authorisation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing authorisation in France. It is published on the Agency’s website. The Director General of the Agence nationale de sécurité du médicament et des produits de santé sends a copy of the parallel import authorisation to the holder of the…

The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the proprietary medicinal product, prior to its marketing. It also provides the marketing authorisation holder, at his request, with a sample of the medicinal product as it will be marketed. When the product is first placed on the market,…