Guidelines on Submission of Documentation for Prequalification of Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 986, 2014, Annex 5
(2014; 4 pages)

Abstract

The revision of the WHO Guidelines on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities is extended to include not only innovator products, but also multisource products. The title is accordingly changed to Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities. These guidelines apply to both innovator and multisource (generic) finished pharmaceutical products (FPPs) approved by SRAs.

 
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