Chapter I: General provisions

The purpose of the compassionate prescribing framework referred to in Article L. 5121-12-1 is to ensure the safety of prescribing a medicinal product which does not comply with its marketing authorisation, in order to meet the special needs of the patients concerned. It may be established, in the absence of an authorised medicinal product with the same active substance, the same pharmaceutical form and the same strength, when the conditions…

Any practice of prescribing a medicinal product outside the scope of its marketing authorisation may be reported by electronic means to the Director General of the Agency, to enable him to assess the appropriateness of establishing a compassionate prescribing framework for the indication or indications in question. These reports come from, in their respective fields of intervention: 1° The National Cancer Institute ; 2° The centres of reference and the…

When it is considering drawing up a compassionate prescribing framework, the Agence nationale de sécurité du médicament et des produits de santé may, by any means capable of giving a date certain of receipt, ask the marketing authorisation holder of the medicinal product concerned, or the company responsible for its use authorised for this purpose by the marketing authorisation holder, to send it all or some of the following information…