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.
This decree establishes an autonomous fund to receive revenues from the recovery of primary health care costs in each Integrated Health Center. This fund will primarily support the purchase of essential generic drugs and consumables, the purchase of management tools for cost recovery and the payment of managers' salaries.
This Act makes provision requiring public corporations, companies, persons and other business enterprises to make financial contributions towards the operation and maintenance of the medical services, and connected matters.