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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)
Índice de contenido
Ver el documentoSection 1. Details of the product
Ver el documentoSection 2. Regulatory situation in other countries
Abrir esta carpeta y ver su contenidoSection 3. Active pharmaceutical ingredient (s) (API)
Abrir esta carpeta y ver su contenidoSection 4. Finished product
Abrir esta carpeta y ver su contenidoSection 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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