This decree sets out the contractual framework between the managing body and the "Organismes Gestionnaires Délégués" (Delegated Management Organizations) of the universal health insurance scheme.
The decree defines the values and nomenclatures for pharmaceutical acts and products covered by the universal health insurance scheme.
These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.
The objective of this decree is to define the modalities and procedures for concluding, suspending and terminating agreements governing relations between the Health Insurance Fund (IPS-CNAM) and healthcare providers.
Dangerous Drug Act
This Act provides for the regulation, control and classification of dangerous drugs.