Section 10: Import and export

Any medicinal product which does not have a marketing authorisation as referred to in Article L. 5121-8 or an early access authorisation as referred to in Article L. 5121-12 or a compassionate access authorisation as referred to in II of Article L. 5121-12-1 as referred to in Article L. 5121-12 or a registration as referred to in Article L. 5121-13 or an authorisation as referred to in 12° or 13°…

For finished products, defined as medicinal products that have undergone all stages of manufacture, including packaging, an import authorisation is required for each import operation. For medicinal products other than finished products, and for medicinal products necessary for carrying out research involving the human person declared under the law of 20 December 1988, the import authorisation is required for a series of import operations envisaged for each medicinal product over…

Private individuals may only import a medicinal product in a quantity compatible with personal therapeutic use for a period of treatment not exceeding three months under normal conditions of use, or for the period of treatment stipulated in the prescription prescribing the medicinal product. If they transport this medicine personally, they are exempt from authorisation. When they import medicinal products by means other than personal transport, they are exempt from…

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;…