Title II: Medicinal products for human use

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After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product no longer satisfies the conditions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.

The proprietary medicinal product benefiting from a parallel import authorisation is subject to the provisions of the marketing authorisation for the proprietary medicinal product which obtained the marketing authorisation in France relating to: -the summary of product characteristics, with the exception of the stability period and special storage precautions, which are those provided for in the marketing authorisation obtained in the country of origin when they are stricter than those…

When the marketing authorisation for the proprietary medicinal product that has been granted a marketing authorisation in France is amended by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the Director General will notify the holder of the parallel import authorisation of this amendment, who will take the necessary measures to ensure that the proprietary medicinal product benefiting from the parallel import…

The operation, as defined in the second paragraph of 3° of Article R. 5124-2, of a proprietary medicinal product benefiting from a parallel import authorisation is carried out by the holder of this authorisation, provided that he has obtained the authorisation to open the business provided for in the first paragraph of Article L. 5124-3.

The holder of a parallel import authorisation shall immediately inform the holder of the marketing authorisation in the State of origin and the holder of the marketing authorisation for the medicinal product which has obtained the marketing authorisation in France of any serious adverse reaction, within the meaning of Article R. 5121-153, concerning the imported medicinal product, as soon as he is aware of it. It will also inform the…

For pharmaceutical products with a parallel import authorisation, Customs officers check the import authorisation number on the packaging. If this number does not appear on the packaging at the time of import, the parallel import authorisation must be produced when the product is inspected by customs officers.

The certificates referred to in Article L. 5124-11 are issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These certificates are valid for three years.

When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a medicinal product, he shall first notify the pharmaceutical establishment carrying out the export of his intention and the reasons for it. The latter has one month to submit its observations. In urgent cases, the Director General…