Part five: Health products

Non-profit humanitarian organisations may have a pharmaceutical establishment, which they own, which wholesales medicinal products to similar organisations with the same purpose in France or in a State of the European Union or another State party to the agreement on the European Economic Area, or which exports them for the same humanitarian purposes to a State which is not a member of the said Union or not party to the…

I.-The provisions of articles L. 5124-1 and L. 5124-2, with the exception of the provisions of the first paragraph of this article, apply to the medical supply establishments of the armed forces health service responsible for the import, export and wholesale distribution of medicines, products and articles mentioned in article L. 4211-1, as well as to the Pharmacie centrale des armées. The medicinal products mentioned in the aforementioned article and…

The medicinal products mentioned in II and III of article L. 5124-8 are manufactured in accordance with the good practices provided for in article L. 5138-3, subject to adaptations made necessary by specific defence requirements and having received the assent of the Agence nationale de sécurité du médicament et des produits de santé.

In the absence of an available or suitable pharmaceutical speciality, the medical supply establishments of the armed forces health service may, in order to meet specific defence requirements, import, export and distribute, after obtaining the opinion of the Agence nationale de sécurité du médicament et des produits de santé, a medicinal product authorised in another Member State of the European Union or a State party to the Agreement on the…

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…