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Health Legislation

Health Legislation

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The purpose of this ordinance is to determine the rates and fees for regulatory services offered on drugs and other health products by the drug regulatory authority for Burundi (ABREMA).

The order of 11 Joumada El Oula 1442 corresponding to 26 December 2020 lays down the procedure for setting the prices of medicinal products by the intersectoral economic committee for medicinal products. The text of this order was published in the official journal of 27 December 2020 (see pages 33-36).

The code aims to promote and guarantee children's access to the enjoyment and exercise of their rights.

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 Regulation establishes the pricing system for medicinal products. All medicines circulating in Mozambique shall be subject to the pricing system provided for in these regulations.

Dangerous Drug Act

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

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