Part five: Health products

I. – An in-house pharmacy is managed by a pharmacist. The latter is responsible for compliance with the provisions of this Code relating to pharmaceutical activity. II. – Pharmacists practising within an internal-use pharmacy practice their profession personally. They may be assisted by authorised persons within the meaning of Title IV of Book II of Part Four and by other categories of specialised staff who are assigned to the internal-use…

I. – The creation, transfer or closure of a pharmacy for internal use is subject to the granting of an authorisation issued by the Director General of the Regional Health Agency after obtaining the opinion of the competent council of the National Order of Pharmacists. With the exception of substantial changes, which are subject to a new authorisation, changes to the information contained in the authorisation are subject to a…

Without prejudice to the provisions of Article L. 5126-1 : 1° Internal-use pharmacies may prepare sterile medical devices or their accessories for healthcare professionals and biologists in charge of medical biology laboratories practising outside healthcare establishments; 2° For certain categories of preparations that must meet specific safety and quality requirements, the list of which is set by decree, an internal-use pharmacy in a healthcare establishment may entrust the preparation of…

By way of derogation from the provisions of I of Article L. 5126-1 : 1° For reasons of public health, in the interest of patients or, where applicable, at the request of the ministers responsible for health and social security, the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall draw up…

I.-As part of the research referred to in Article L. 1121-1, the clinical investigations referred to in Article L. 1125-1 and the performance studies referred to in Article L. 1126-1, the internal-use pharmacy may dispense the products required for these to investigators in the research sites where the research is authorised. In the context of the same research, the pharmacy for internal use may distribute the medicinal products and devices…

I. – The Director General of the Regional Health Agency may authorise, for a limited period, the in-house pharmacies of public health establishments: 1° To supply other in-house pharmacies when there is no other possible source of supply for a given medicinal product or product. However, in the case of an imperative and immediate need, the supply may be carried out without the authorisation provided for in the previous paragraph,…

For the application of articles L. 5126-5, L. 5126-6 and L. 5126-7, army hospitals and the Institution nationale des invalides are considered to be health establishments.

I.-When the pharmaceutical needs of an establishment, service or body covered by III of Article L. 5126-1 which is not part of a territorial hospital grouping or which is not a member of a health cooperation grouping mentioned in 4° of Article L. 6133-1 or in Article L. 6133-7 do not justify the existence of an in-house pharmacy, the medicines, products or objects mentioned in article L. 4211-1 and sterile…

Unless otherwise provided, the terms and conditions for the application of this chapter shall be determined by decree in the Conseil d’Etat.