French Public Health Code
In forceBy 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 the list of medicinal products that certain health establishments or health cooperation groups with an in-house pharmacy are authorised to sell to the public, at retail and in compliance with the conditions laid down in Articles L. 5123-2 and L. 5123-4. This list is published on the Agency's website. Medicinal products included on the list may be home-delivered.
Medicinal products which are not classified in the category of medicinal products reserved for hospital use and which are the subject of an early access authorisation mentioned in article L. 5121-12 or which benefit from the system relating to continuity of treatment initiated in this respect in application of article L. 162-16-5-4 of the Social Security Code, as well as medicinal products which are the subject of an authorisation or a compassionate prescription framework mentioned in article L. 5121-12-1 of the present code or which benefit from the system relating to the continuity of treatments initiated on this basis in application of VI of article L. 162-16-5-2 of the Social Security Code. The present paragraph applies without prejudice to the existence of another supply circuit for medicinal products covered by a compassionate prescription framework for a given indication.
The conditions for the use of medicinal products and sterile medical devices are laid down jointly by the ministers responsible for health and social security.
2° For reasons of public health or in the interests of patients, the Minister for Health sets by decree the list of foodstuffs intended for special medical purposes, defined in Article L. 5137-1, that in-house pharmacies are authorised to supply;
3° Internal-use pharmacies may supply magistral preparations, hospital preparations and reconstituted proprietary medicinal products to private healthcare professionals participating in a coordination support scheme or a specific regional scheme mentioned in Articles L. 6327-2 and L. 6327-6;
4° The pharmaceutical establishments of health establishments may, in exceptional circumstances and provided that the authorisation issued in application of article L. 5124-9 specifies this, subcontract, under their responsibility, the production of hospital preparations to a pharmaceutical establishment authorised to manufacture medicinal products. This subcontracting is the subject of an annual report sent by the pharmacist in charge of the pharmaceutical establishment of the health establishments concerned to the Minister for Health and to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
These establishments may also supply hospital preparations and reconstituted proprietary medicinal products to private healthcare professionals participating in a coordination support scheme or a specific regional scheme mentioned in articles L. 6327-2 and L. 6327-6;
5° Hospital preparations and reconstituted pharmaceutical specialities may be manufactured by the Armed Forces Central Pharmacy and supplied by the Armed Forces Health Supply Establishments;
6° Persons held in prisons and persons detained in application of article L. 551-1 of the Code de l'Entrée et de Séjour des Etrangers et du Droit d'As asile (Code on the Entry and Residence of Foreigners and the Right of Asylum) benefit from the internal use pharmacy services of health establishments which provide care to prisoners in application of article L. 6111-1-2 of this Code.
