Section 14: Inclusion on the list of medicinal products for officinal use

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall draw up the list of medicinal products, known as medicinal products for officinal use, which the dispensing pharmacist may present for direct access to the public under the conditions set out in article R. 4235-55. It is published on the Agency’s website. At the request of the marketing authorisation holder or the person…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision, refuse to include a medicinal product on the list referred to in Article R. 5121-202 for any public health reason, in particular when the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9 is being reassessed.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or remove the registration of a medicinal product from the list provided for in article R. 5121-202 if the conditions laid down in this article are no longer met or for any public health reason, in particular when the benefit/risk balance of the medicinal product as defined in the first paragraph of…