In accordance with the WHO prequalification procedure, holders of prequalified finished pharmaceutical products (FPPs) should submit a quality review five years after the date of prequalification, or will be invited to do so earlier, if WHO considers this to be necessary. This procedure forms part of the maintenance of the prequalified FPP, and is called “requalification”. The procedure is applicable only to FPPs that have been prequalified via the full assessment (multisource generic) route.
WHO assesses the data and information submitted in the quality review to verify that the prequalified product continues to meet current norms and standards. It also uses the data and information supplied to assess the consistency of product quality and manufacturing process(es) over the identified period.
LETTER OF REQUALIFICATION