Title II: Medicinal products for human use

The companies or organisations mentioned in article R. 5124-2 are not authorised to supply to the public the medicinal products, products or objects mentioned in article L. 4211-1 and in 4° of article L. 5121-1.

The provisions of article R. 5124-42 do not prevent companies or organisations authorised under 1°, 2°, 3°, 4°, 5°, 6° (with the exception of intermediate products), 12° and 14° of article R. 5124-2 sell directly to practitioners authorised to use them and for exclusive use by these practitioners for their professional use, on written order from the practitioner made under the conditions provided for in Article R. 5132-4 : 1°…

Nor do the provisions of article R. 5124-42 prevent the companies or organisations mentioned in article R. 5124-43 from selling directly, provided that batches are individually monitored and, if necessary, withdrawn: 1° To veterinarians, for exclusive use by these veterinarians for their professional use on written order, the medicinal products appearing on the lists provided for in articles R. 5141-122 and R. 5141-122-1 ; 2° To organisations authorised to carry…

In addition to their distribution activities to pharmacies, mutual benefit pharmacies or pharmacies of mining relief societies and pharmacies for internal use, the companies or organisations authorised under 1°, 2°, 3°, 4°, 5°, 6° (with the exception of intermediate products), 8°, 12° and 14° of article R. 5124-2 supply, by carrying out individualised batch monitoring and, if necessary, their withdrawal: 1° 1° To the Etablissement Français du Sang (French Blood…

Pharmaceutical establishments operate in accordance with the good practices mentioned in article L. 5121-5 which are applicable to them. In particular, they have : 1° Premises fitted out, arranged and maintained according to the pharmaceutical operations carried out there; 2° The staff and equipment required to carry out these activities. Each year, by means of a dedicated internet portal, they send the Director General of the Agence nationale de sécurité…

The companies and organisations mentioned in article R. 5124-2 may not subcontract any of the activities defined in the same article or any of the operations mentioned in article R. 5124-40, subject to the exceptions mentioned below: 1° Manufacturers and importers of medicinal products mentioned in 1° of article L. 4211-1 and manufacturers and importers of generators, kits or precursors mentioned in 3° of the same article may subcontract part…

The companies and organisations mentioned in article R. 5124-2 take the necessary measures to ensure that medicinal products and other pharmaceutical products are transported and delivered under conditions that guarantee their proper preservation, integrity and safety.

Marketing authorisation holders and pharmaceutical companies and organisations exploiting or distributing a medicinal product in France ensure, within the limits of their respective responsibilities, an appropriate and continuous supply to pharmacies and persons authorised to supply medicinal products, so as to cover the needs of patients in France. Marketing authorisation holders and pharmaceutical companies exploiting medicinal products ensure an appropriate and continuous supply to all establishments authorised to carry out…

When the companies and organisations mentioned in article R. 5124-2 become aware of the falsification or suspected falsification of medicinal products which they manufacture, operate or distribute, whether these products are distributed via the legal supply chain or by illegal means, including illegal sales via information society services, they shall inform the Agence nationale de sécurité du médicament et des produits de santé and the marketing authorisation holder without delay.