French Public Health Code
In forceAny 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 centres of competence within each of the health networks defined at national level for the treatment of rare diseases, in accordance with the procedures laid down by an order of the Minister for Health;
3° The competent national professional councils mentioned in article L. 4021-3 ;
4° Any patient association approved under article L. 1114-1.
The observatories for medicinal products, medical devices and therapeutic innovation mentioned in article R. 1413-90 transmit to the bodies mentioned in 1° to 3° above, under conditions set by order of the Minister for Health, information concerning prescriptions for medicinal products which do not comply with their marketing authorisation and which are likely to be the subject of an alert.
The reasons for the alert must be given. The author's position on the appropriateness of using the medicinal product in the indication in question is supported by reference, in particular, to current therapeutic management practices and recommendations, scientific publications and French and international clinical data available concerning the efficacy and risks of such use.
When the indication concerns a rare disease, the notification from the centres of reference and centres of competence includes an initial analysis of the efficacy and safety of the use of the medicinal product in the indication in question. This analysis takes into account, in particular, current therapeutic management practices and recommendations, the work carried out by these centres and any data they hold.
The Director General of the Agency will inform the author of the alert of the progress of the investigation and, once this has been completed, of the action taken.
