Section 10: Import and export

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,…

The application for renewal of the parallel import authorisation must be submitted no later than three months before the expiry date of the parallel import authorisation. It must be accompanied by a document certifying that there has been no change in the information provided by the interested party, either in support of the initial authorisation application, or at the time of the last renewal application, or during the authorisation period….

After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product no longer satisfies the conditions of the authorisation. Except in emergencies, such decisions to suspend or withdraw authorisations may only be taken after the authorisation holder has been given the opportunity to present its observations.

For each parallel import operation, the authorisation holder notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch numbers of the authorised medicinal product being imported, stating the parallel import authorisation number, the name, strength and pharmaceutical form of the imported medicinal product and the country of origin.