Part five: Health products

The Agency is subject to an administrative, budgetary, financial and accounting system and to State control adapted to the specific nature of its mission, as defined in this Book and specified by decree in the Conseil d’Etat.

The agency’s resources are made up of : 1° A subsidy from the State ; 2° Subsidies from other public authorities, their public establishments, social security bodies, the European Union or international organisations; 3° From miscellaneous income, donations and legacies; 4° By loans; 5° A grant from the compulsory health insurance schemes, paid and distributed in accordance with conditions laid down by decree. The Agency may not receive donations from…

I.-A fee is payable by the applicant for the performance by the Agency of the following operations: 1° Analysis of samples and evaluation of the documentation relating to the control protocol submitted by the manufacturer with a view to the release of batches of immunological medicinal products mentioned in 6° of Article L. 5121-1, blood-derived medicinal products mentioned in Article L. 5121-3 and substances which, if used separately from a…

A decree in the Conseil d’Etat shall determine the conditions under which one or more of the Agency’s support and back-up services may be pooled with one or more services of other bodies pursuant to Article L. 1411-5-3.