Section 10: Import and export

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…

The declaration provided for in the fourth paragraph of Article L. 5124-11 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of providing a date certain by the exporting pharmaceutical establishment prior to the export of a medicinal product, in the case of the first export of this medicinal product to the importing State. This declaration is accompanied by…

I.- Articles R. 5121-133 to R. 5121-135 do not apply to gene therapy and xenogenic cell therapy preparations. II-Any gene therapy or xenogenic cell therapy preparation that does not have the authorisation mentioned in 12° or 13° of Article L. 5121-1 is subject to an export authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. III – The application for…

The provisions of this section apply to the import and export of : 1° Medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in part ; 2° Medicinal products classified as psychotropic. However, these medicinal products remain subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-27 and R. 5132-86.