French Public Health Code
In forceI.-The prescriber's request for compassionate access authorisation as provided for in II of Article L. 5121-12-1 is sent to the Agence nationale de sécurité du médicament et des produits de santé by electronic means by the pharmacist managing the internal use pharmacy of a healthcare establishment or by the person in charge as referred to in Article L. 5126-10.
It includes the following information
1° The name and position of the prescribing doctor and the name of the pharmacist or manager referred to in Article L. 5126-10 who sends the request ;
2° The initials of the patient's surname and forename, age, sex and weight;
3° The name of the medicinal product concerned or, where applicable, its code name or international non-proprietary name, its pharmaceutical form and its strength;
4° The therapeutic indication for which this medicinal product is prescribed for the patient in question and the dosage envisaged;
5° Where applicable, the references of the research involving the human person mentioned in 1° and 2° of article L. 1121-1 for commercial purposes, including the clinical trial mentioned in article L. 1124-1, in progress, for the medicinal product concerned;
6° The prescriber's undertaking that his application complies with the granting criteria set out in the reference document referred to in Article R. 5121-74-10 or, failing this, the reasons for the application including the information needed to establish, in the indication requested, that :
a) The patient cannot be included in any research involving the human body, including a clinical trial, currently underway ;
b) There is no appropriate treatment;
c) The efficacy and safety of the medicinal product are presumed on the basis of the available clinical data.
The prescriber must specify whether or not implementation of the treatment can be deferred;
7° The prescriber's undertaking to provide the patient with information in accordance with the provisions of VI of article L. 5121-12-1 and to record the procedure followed in the medical record in accordance with the same VI;
8° Where the medicinal product is not mentioned in the reference database referred to in Article R. 5121-74-10, any information available to the prescriber about this medicinal product at the time of the request;
9° Where applicable, the prescriber's undertaking to collect and transmit data on the follow-up of patients treated as required by the therapeutic use and patient follow-up protocol referred to in article R. 5121-74-5, in accordance with the procedures set out in this protocol.
II -During the examination of the application, the applicant must forward without delay to the Director General of the Agency any additional information relating to the constituent elements of the application and any new data which he possesses or becomes aware of and which may influence the assessment of the risk-benefit balance of the medicinal product.
III -Where the application for authorisation for compassionate access concerns a medicinal product composed, in whole or in part, of genetically modified organisms, the provisions of Article R. 533-49 of the Environment Code shall apply.
