Chapter IV: Manufacturing and wholesale distribution.

To meet specific defence requirements, the medical supply establishments of the armed forces health service may repackage and repackage health products in accordance with the rules laid down by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products). These rules shall take account of the specific characteristics of the armed forces health service. Repackaged medicinal products…

Subject to fulfilling their priority mission of providing medical support to the armed forces as mentioned in article L. 6147-7, the medical supply establishments of the armed forces health service may carry out the activities mentioned in I of article L. 5124-8 and in article L. 5124-8-3 on behalf of other ministerial departments or public or private organisations responsible for a public service mission contributing to national security.

Notwithstanding the provisions of the first paragraph of article L. 5124-2, public health establishments manufacturing medicinal products industrially on 31 December 1991 may apply for the authorisation provided for in article L. 5124-3.

The activities referred to in Article L. 5124-1 may be carried out by pharmaceutical establishments set up within non-profit organisations or public establishments other than health establishments: 1° When these activities concern radiopharmaceutical medicinal products ; 2° When these activities concern advanced therapy medicinal products as defined in 17° of Article L. 5121-1 and advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the…

Notwithstanding the provisions of Article L. 4211-1 and those of the first paragraph of Article L. 5124-2, Institut Pasteur remains authorised to ensure, in accordance with its statutes, the preparation and distribution of attenuated or non-attenuated viruses, therapeutic sera, modified or non-modified toxins, and in general the various products of non-chemically defined microbial origin which may be used, in any form, for diagnosis, prophylaxis or therapy, as well as allergens.

A pharmaceutical establishment exporting a medicinal product must ask the Agence nationale de sécurité du médicament et des produits de santé to certify that it holds the authorisation referred to in article L. 5124-3 or, for establishments or organisations manufacturing products referred to in article L. 1243-1 and in 12° and 13° of article L. 5121-1, the authorisation referred to in articles L. 1243-2, L. 4211-8 and L. 4211-9. A…

The 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…

In the case of research involving the human person relating to the gene therapy and xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1, the authorisation to conduct the research also constitutes authorisation for this research of the storage and preparation sites mentioned in Articles L. 4211-8 and L. 4211-9, and it constitutes the import and export authorisation mentioned in Article L. 5124-13.

A proprietary medicinal product subject to parallel distribution is a proprietary medicinal product : 1° Has a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 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 ; 2° And imported from…

The limited company called “Laboratoire Français du fractionnement et des biotechnologies” carries out research, production and marketing activities for medicinal products for human use, in particular medicinal products derived from blood, medicinal products that can be substituted for medicinal products derived from blood and health products derived from biotechnologies. The majority of its capital is held by the State, its public establishments or other companies or bodies belonging to the…