Section 10a: Parallel distribution

I.-When a company intends to ensure the parallel distribution in France of a proprietary medicinal product within the meaning of Article L. 5124-13-2, it shall inform the marketing authorisation holder of this intention and send the Director General of the Agence nationale de sécurité du médicament et des produits de santé the parallel distribution notification issued by the European Medicines Agency pursuant to Article 57 o of Regulation 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

This notification must be accompanied by the following information

1° The name or corporate name of the company and its address, as well as a copy of its authorisation to open;

2° If it is separate from the company that carries out parallel distribution, the name or corporate name and address of the establishment responsible for changing the packaging;

3° If the batches of the medicinal product concerned are not stored by the company which carries out the parallel distribution or, where applicable, by the establishment which carried out the change of packaging, the name or corporate name and address of the depository within the meaning of 4° of Article R. 5124-2 who will be responsible for storage;

4° The draft packaging of the proprietary medicinal product as it will be marketed in France.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will inform the company, within thirty days of receipt of the complete application, of the information that must appear on the outer packaging of the proprietary medicinal product pursuant to Article R. 5121-137. It may request from the applicant, in a letter stating the reasons for the request, any additional information it deems necessary to reach a decision on the application. The aforementioned time limit is suspended until receipt of the information requested. If the Director General of the Agence nationale de sécurité du médicament et des produits de santé does not respond within thirty days, this constitutes authorisation to carry out parallel distribution with the packaging referred to in 4°.

II - The list of proprietary medicinal products subject to a notification of parallel distribution issued by the European Medicines Agency is published on the website of the Agence nationale de sécurité du médicament et des produits de santé.