Chapter III: Pricing and approval.

Medicinal products and products the sale of which is reserved for pharmacists, with the exception of the medicinal products and products mentioned in article L. 5121-8, may not be sold at a price higher than that resulting from the national pharmaceutical tariff. This tariff is set by order of the ministers responsible for the economy and finance, health and social security. Medicinal products on the list provided for in the…

The purchase, supply, assumption of responsibility and use by public authorities of medicinal products defined in articles L. 5121-8, L. 5121-9-1, L. 5121-13 and L. 5121-14-1 or benefiting from a parallel import authorisation pursuant to article L. 5124-13 or being the subject of parallel distribution within the meaning of article L. 5124-13-2 are limited, under the conditions specific to these medicinal products set by the decree referred to in article…

The list referred to in article L. 5123-2 is proposed by a commission of the Haute Autorité de santé referred to in article L. 161-37 of the Social Security Code, the composition and operation of which are set by decree in the Conseil d’Etat. The commission may hear medical or pharmaceutical experts, as well as qualified representatives of organisations or services whose opinion the commission wishes to have.

The list of approved products may include several categories, each corresponding to one or more of the categories of users mentioned in article L. 5123-6. An order of the ministers responsible for veterans, defence and health sets out the terms and conditions of their classification.

Only specialised products approved for the corresponding categories of users may be : 1° Purchased and used, except in emergencies, by civilian and military health establishments; 2° Purchased and used by local public authorities and organisations of any kind whose resources come in whole or in part from public authority subsidies; 3° Supplied free of charge to beneficiaries of article L. 115 of the Code des pensions militaires d’invalidité et…

In order to avoid wasting medicines and without infringing on the freedom of medical prescriptions, special arrangements may be laid down by decree for the supply of medicines to beneficiaries of a health insurance scheme and to recipients of social assistance.

In order to avoid wasting medicines, when their pharmaceutical form allows it, certain medicines may be dispensed individually in pharmacies. An order of the ministers responsible for health and social security sets the list of medicines covered by this article. A Conseil d’Etat decree sets out the specific packaging, labelling, information and traceability requirements for these medicinal products.