(2003; 148 pages)
2.7 Assessment results
Once WHO is satisfied that the quality assessment process is complete for the manufacturer of the relevant product and that the product is acceptable in principle for procurement by UN Agencies (i.e. it has been found to meet the WHO recommended standards), the product, as produced at the specified manufacturing site, will be included in the list.
Manufacturers on the list will be considered to be manufacturing the relevant listed pharmaceutical products, of acceptable quality, and in compliance with WHO recommended GMP guidelines and other recommended standards, such as described in “Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. A Manual for a Drug Regulatory Authority. Regulatory Support Series, No.5 (WHO/DMP/RGS/98.5). Geneva, World Health Organization, 1999. The quality assessment is valid only for those product(s) submitted by the manufacturer in the EOI, evaluated by WHO, and appearing on the list.
Each manufacturer receives a letter from WHO informing the manufacturer of the outcome of the quality assessment process in regard of the particular product(s) of that particular manufacturer. A copy of this letter will be sent to the DRA of the country of manufacture.
The list will be compiled in accordance with an SOP established by WHO for final decision making for inclusion in the list and will be subjected to review at least once a year. The list will be published and be included on the WHO web page.