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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
(11 pages)
Table of Contents
View the documentSection 1. Details of the product
View the documentSection 2. Regulatory situation in other countries
Open this folder and view contentsSection 3. Active pharmaceutical ingredient (s) (API)
Open this folder and view contentsSection 4. Finished product
Open this folder and view contentsSection 5. Efficacy and safety
 

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.

 

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