Book I: Pharmaceutical products

The application for an import authorisation must be sent by any means capable of providing a date certain and must indicate : 1° The name or business name and address of the natural or legal person responsible for the import or, for gene therapy or xenogenic cell therapy preparations, the name and address of the establishment or body authorised under Article L. 4211-8 or Article L. 4211-9; 2° The country…

The application must be accompanied by : 1° For medicinal products imported for research involving the human person, an acknowledgement of receipt of the application sent to the Agence nationale de sécurité du médicament et des produits de santé as provided for in articles L. 1123-8 and R. 1123-30 ; however, where the implementation of the research is of an urgent nature, this document may be replaced by a letter…

If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-111 and R. 5121-112. The time limit mentioned in the previous paragraph is extended by fifteen days if the Director General of…

The import authorisation or, for private individuals, a copy of the authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate access authorisation under II of article L. 5121-12-1 granted for an imported medicinal product or a copy of the authorisation referred to in 12° or 13° of article L. 5121-1 must be presented at the time of…

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…