French Public Health Code
In forceI. - On the basis of the information referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R. 5121-76-2, the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall assess the efficacy and safety of the medicinal product in the indication in question.
If this assessment leads to the presumption that the ratio between the expected benefit and the adverse effects incurred is favourable, the Agency will draw up a draft compassionate prescription framework.
II. - If the Agency does not intend to waive the obligation to include a therapeutic use and patient monitoring protocol in the compassionate prescribing framework, as provided for in V of Article L. 5121-12-1, it will ask the marketing authorisation holder for the medicinal product or the company commissioned to operate the medicinal product to send it, with a view to preparing this protocol, proposals relating to the elements of this protocol mentioned in 1° of Article R. 5121-76-6.
The holder or operator sends these proposals to the Agency by electronic means within a period set by the Agency, which may not exceed two months.
III. - The Director General of the Agency draws up a draft compassionate prescribing framework meeting the requirements of Article R. 5121-76-5 accompanied, where applicable, by a draft therapeutic use and patient monitoring protocol meeting the requirements of Article R. 5121-76-6. When it is envisaged, for a rare disease, that the centres of reference and competence in charge of the disease will provide support for the implementation of the protocol, this possibility will be the subject of prior consultation with these centres in accordance with the procedures laid down by an order of the Minister for Health.
The Director General of the Agency will send the projects mentioned in the previous paragraph to the marketing authorisation holder or to the company authorised to operate the medicinal product, by any means which confers a date of receipt. It will inform the marketing authorisation holder or the company operating the medicinal product of the date envisaged for the entry into force of the compassionate prescribing framework.
The proprietor or operator may submit its observations on this proposal within a period set by the Agency which, except in emergencies, may not be less than one month.
At the end of this period, the Director General of the Agency may establish the compassionate prescribing framework and, where appropriate, the protocol for therapeutic use and patient monitoring. The holder of the marketing authorisation for the medicinal product or the company commissioned to operate it is informed of their publication.
