Section 10: Import and export

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 to the proprietary medicinal product which is the subject of the parallel import authorisation application:

a) State of origin ;

b) The name, strength and contents of the packaging of the proprietary medicinal product in the State of origin, by weight, volume or number of dosage units, as well as the name within the meaning of Article R. 5121-1 and the contents of the packaging of the proprietary medicinal product as it will be marketed in France;

c) A detailed description of the medicinal product, including its size, shape, colour, engraving, printing or any other marking;

d) The number of the marketing authorisation granted to it in the State of origin, together with the name or corporate name and address of the holder of the marketing authorisation;

e) The pharmaceutical form, route of administration, qualitative and quantitative composition in active substances and qualitative composition in excipients;

f) The name or corporate name and the address of the undertaking or undertakings situated in the State of origin from which the applicant has obtained the proprietary medicinal product;

g) The name or corporate name and address of the manufacturer of the medicinal product;

h) If different from the applicant, the name or corporate name and address of the establishment authorised under Article 40 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 to carry out the changes to the packaging;

i) A precise description of the process for modifying the packaging of the medicinal product as it will be marketed in France once parallel import authorisation has been obtained;

j) If the imported batches of proprietary medicinal products are not stored by the applicant itself or by the establishment which has carried out the change of packaging, the name or corporate name and address of the depository within the meaning of 4° ofArticle R. 5124-2 which will be responsible for storage.