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).
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 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).
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.
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.