Chapter IV: Manufacturing and wholesale distribution.

The manufacture, import, export and wholesale distribution of medicinal products, products and articles mentioned in article L. 4211-1, the manufacture, import and distribution of investigational medicinal products, with the exception of gene therapy preparations and xenogenic cell therapy preparations, as well as the operation of proprietary medicinal products or other medicinal products, generators, kits or precursors defined in 8°, 9° and 10° of article L. 5121-1 may only be carried…

Any business that includes at least one pharmaceutical establishment must be owned by a pharmacist or by a company in whose management or general management a pharmacist participates. It may be wholly or partly leased to a company. This company must be owned by a pharmacist or involve the participation of a pharmacist in its general management or management. The pharmacists mentioned in the previous paragraph are referred to as…

The opening of a pharmaceutical establishment, whatever its activity, is subject to an authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé. This authorisation may, after formal notice, be suspended or withdrawn in the event of infringement of the provisions of this Book and of Book II of Part IV. Any substantial modification of the elements of the initial authorisation is subject to prior…

The pharmacist in charge and the delegated pharmacists must practise their profession personally. They must be assisted and, in the event of temporary absence or if they are banned from practising, they must be replaced. In the event of the death of the pharmacist who owns a pharmaceutical establishment, the period during which his spouse or heirs may have the establishment managed by a pharmacist authorised for this purpose by…

When a medicinal product or product subject to the marketing authorisation provided for in Article L. 5121-8, to registration as a traditional herbal medicinal product or to registration as a homeopathic medicinal product is marketed, the company operating the medicinal product or product must notify the Agence nationale de sécurité du médicament et des produits de santé without delay of the marketing dates for each presentation of the medicinal product…

Any pharmaceutical company exploiting a medicinal product or product subject to the provisions of Chapter I of this Title which takes the decision to suspend or cease marketing thereof or which has knowledge of facts likely to lead to the suspension or cessation of such marketing shall inform the Agence nationale de sécurité du médicament et des produits de santé, specifying the reasons for its action, at least one year…

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…