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Health Legislation

Health Legislation

Results (6)

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.

Guidelines for Registration of Human Vaccines

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.

This decision by the minister of public health provides for pricing scheme for the treatment of severe malaria.

This decision by the minister of public health provides the prices and conditions of availability of rapid malaria diagnosis kits.

Dangerous Drug Act

This Act provides for the regulation, control and classification of dangerous drugs.

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