Guide to Preparing Marketing Authorisation Applications for Herbal Medicines

This short guide published by the Ministry of Public Health and Population provides practical orientation for assembling applications for marketing authorization of phytomedicines, and is addressed to enterprises interested in producing traditional medicines and remedies. It matters beyond its length because it is the point at which Haiti's traditional-medicine sector meets pharmaceutical regulation: herbal preparations are widely produced and sold, and the guide sets out what the regulator expects before such a product can be lawfully placed on the market. It sits alongside the ministry's other pharmacy instruments - the National List of Essential Medicines and the procedure for local preparation of hand-sanitising solutions - as part of the small documented body of Haitian pharmaceutical regulation.