Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria
(These guidelines are based on the WHO document "Marketing Authorization of Pharmaceutical Products with special Reference to Multisource (Generic) Products: a Manual for a Drug Regulatory Authority, WHO/DMP/RGS/98.5 - full text can be found in the web site http://www.who.int/medicines/)
Note: Manufacturers interested in having their antimalarial drug evaluated for acceptability in principle for procurement by UN Agencies should submit a product dossier reflecting the data and information requested below. The sections should be clearly marked (Section 1 to 4.14).
The covering letter submitted with the product dossier should contain a clear statement by the responsible person submitting the product dossier, indicating that the information submitted is true and correct.