Title II: Medicinal products for human use

The provisions of this section apply to the internal use pharmacies of the establishments, services or organisations mentioned in 1° of article R. 5126-1, with the exception of the Institution nationale des invalides. For the purposes of this section, army hospitals are considered to be health establishments.

Where the internal-use pharmacy of a health care institution is authorised to supply medicinal products or health care products to the public pursuant to 1° and 2° of Article L. 5126-6 or Article L. 6111-1-1, the internal-use pharmacy premises must be equipped in such a way as to respect confidentiality and ensure the safety of the staff concerned.

The list mentioned in 1° of article L. 5126-6, medicinal products : 1° Registered on the initiative of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, for public health reasons in the interest of non-hospitalised patients, when their dispensing to the public by the in-house pharmacy of a health establishment is justified for reasons relating to dispensing or administration constraints, security of…

I.-Medicinal products meeting the following conditions may be included on the list provided for in article R. 5126-58: 1° They benefit from a marketing authorisation, a parallel import authorisation mentioned in article R. 5121-116 or an import authorisation issued in application of article R. 5121-108 in the context of a stock shortage, a risk of a stock shortage or a marketing stoppage or be the subject of parallel distribution within…

The following are deemed to be registered on the list referred to in Article R. 5126-58: 1° Hospital preparations referred to in 2° of Article L. 5121-1 which are the subject of an initial prescription by a doctor who meets the conditions laid down in Article R. 5121-88; 2° Magistral preparations referred to in 1° of Article L. 5121-1 which are produced in a health establishment and which are the…

The following shall be removed from the list mentioned in article R. 5126-58: 1° A medicinal product which ceases to fulfil the condition mentioned in 1°, 2° or 3° of article R. 5126-59. This deletion is carried out automatically and without prior notification of the authorisation holder or the company responsible for its operation or parallel distribution; 2° A medicinal product registered pursuant to 2° of Article R. 5121-58, at…

I.-The Ministers responsible for health and social security, in the case of a medicinal product mentioned in 2° of Article R. 5126-61, or the Director General of the Agency, in the case of a medicinal product mentioned in 3° of this article, will inform the holder of the authorisation, the company or the organisation responsible for its operation or parallel distribution of their intention to deregister this medicinal product, by…