Specifications for essential medicines supplies.
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.
These are the guidelines for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products.
Democratic Republic of the Congo
Lignes directrices sur l’approvisionnement en médicaments essentiels en République Démocratique du Congo
This document provides guidelines on the supply of essential medicines in the Democratic Republic of Congo.