Article R5121-76-11 of the French Public Health Code
Any measures taken by the marketing authorisation holder or the company operating the marketing authorisation to disseminate the compassionate prescribing framework or any information relating to this framework to the healthcare professionals concerned must not constitute advertising within the meaning of Article L. 5122-1. These measures are subject to the prior opinion of the Agence nationale de sécurité du médicament et des produits de santé. The draft measure is forwarded…