The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.
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 law creates a public administrative establishment, with legal personality and financial autonomy, called the Centre national de lutte contre le cancer (National Cancer Center).
Dangerous Drug Act
This Act provides for the regulation, control and classification of dangerous drugs.