The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.
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.
The purpose of the Regulation is to define the procedures for approving pharmaceutical products for human use in the member states of the West African Economic and Monetary Union.
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.