Section 1: General provisions

The information contained in advertising for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therapeutic strategies recommended by the Haute Autorité de santé referred to in article L. 5122-2. All advertising for a traditional herbal medicinal product includes, in addition to the information provided for in articles R. 5122-3 and R. 5122-8, the words:…

The company marketing a medicinal product shall set up an advertising department within the meaning of article L. 5122-1, under the supervision of the pharmacist responsible, which shall ensure compliance with the provisions of sections 1 to 3 of this chapter, and in particular the scientific validity of the information disseminated. The company keeps a copy of each advertisement it issues for a period of three years from the date…

When a medicinal product is the subject of a reassessment of the risk-benefit balance, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform the manufacturer without delay. He shall also inform the operator without delay of the completion and outcome of the reassessment. If the reassessment results in a change to the marketing authorisation or registration requiring a change to the…