French Public Health Code
In forceThe import into the customs territory of medicinal products for human use and the import and export of gene therapy preparations or xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1 are subject to prior authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé.
The marketing authorisation provided for in Article L. 5121-8 and Article L. 5121-9-1, the registrations provided for in Articles L. 5121-13 and L. 5121-14-1, the authorisations or compassionate prescription frameworks provided for in Articles L. 5121-12 and L. 5121-12-1 or the authorisation provided for in 12° and 13° of Article L. 5121-1 are deemed to be authorisations within the meaning of the previous paragraph. The authorisation provided for in article L. 1123-8 is equivalent to an import authorisation for any medicinal product required to carry out the authorised research involving the human person.
Such authorisation is not required for a private individual who personally transports a medicinal product, or for the doctor of a sports team, or for a military health professional accompanying foreign nationals under the conditions provided for in article L. 4061-6, who personally transports a medicinal product or who imports a medicinal product by another means.
When a private individual imports a medicinal product by means other than personal transport, he is also not subject to the requirement for prior authorisation if the medicinal product meets one of the following conditions:
1° It is the subject of a marketing authorisation within the meaning of Article 6 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 or of a registration within the meaning of Articles 14 and 16a of the same Directive in a State party to the Agreement on the European Economic Area;
2° It is authorised in the third country of origin and the individual presents the customs department with a copy of the prescription certifying that the medicinal product is intended for treatment prescribed by a doctor established in the country of origin.
