I.- The maximum value of the period referred to in the second paragraph of II of article L. 5121-12-1 is set at twelve months from the date on which the authorisation referred to in this article is granted. By way of derogation from the previous paragraph, when the indication for which authorisation is sought is a rare disease, the maximum value of the period is increased to eighteen months from…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Article L. 5121-12-1 or if the provisions of this section are not complied with, or for any other public health reason.
I.- Authorisation for compassionate access is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé for the duration of treatment of the patient in question, up to a maximum of one year. This authorisation includes: 1° The name and contact details of the prescriber and the contact details of the pharmacy for internal use in the health establishment or of the…
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. This request is accompanied by any clinical data of which the prescriber was aware during the previous authorisation period and a statement from the prescriber attesting to the interest in continuing the…
I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient monitoring protocol. This protocol specifies in particular the indication concerned, the dosage, the conditions of prescription and dispensing, the obligations relating to pharmacovigilance and, where applicable, the monitoring data relating to efficacy and safety and the conditions of use…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where applicable, his authorised representative, sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé, at intervals established by the protocol, a report called a “periodic summary report”. This report includes in particular: 1° A summary…
In order to be able to continuously assess the benefit/risk balance of the medicinal product, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may at any time request the holder of the marketing rights for the medicinal product which is the subject of the compassionate access authorisation or, where applicable, its authorised representative, to provide it without delay with data enabling it…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw a compassionate access authorisation if the conditions laid down in I, II and V of Article L. 5121-12-1 or the provisions of this section are not complied with, or for any other public health reason. Except in cases of urgency, suspension or withdrawal may only take place after the authorisation…
I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall set the date on which the granting of these authorisations ceases. This date shall be determined having regard to the date of notification of the marketing authorisation and the period required for the medicinal product to…
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé publishes, on the Agency’s website, a reference database of medicinal products which are the subject of a compassionate access authorisation. For each medicinal product, this repository provides access to: 1° Where applicable, the criteria for granting compassionate access authorisation in a given indication and any information necessary for the use of the medicinal product;…
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is a Registered Trademark of
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75001, Paris France
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