Section 8: Restricted prescription medicines

The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescription framework under III of article L. 5121-12-1 or the import authorisation for a medicinal product may classify it in one of the following categories of medicinal products subject to restricted prescription: 1° Medicinal product reserved for hospital use ; 2°…

When presenting a prescription for a medicinal product classified in one of the categories of medicinal products subject to restricted prescription, the pharmacist must ensure, in accordance with the rules of this section, that the prescriber is authorised to prescribe it and, where applicable, that the prescription contains the compulsory information and that the initial prescription is presented at the same time.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, with a view to the application of the provisions of this section and after inviting the marketing authorisation holder to submit his observations, vary the marketing authorisation before the due date for its renewal.

The marketing authorisation, the early access authorisation under 1° of II of article L. 5121-12 or the compassionate access authorisation under II of article L. 5121-12-1 or the compassionate prescription framework under III of article L. 5121-12-1 or the import authorisation for a medicinal product may stipulate that it is only supplied to healthcare professionals authorised to prescribe and administer it, on presentation of an order. 5121-12-1 or the import…

For the application of the provisions of this section, army hospitals and the army blood transfusion centre are considered to be public health establishments and a blood transfusion establishment respectively.