In accordance with the provisions set out in section 12 (Maintenance of prequalification status) of the Procedure for prequalification of pharmaceutical products (see related link below), holders of WHO-prequalified products should submit a quality review after five years from the date of prequalification of the product, or when requested to do so by WHO Prequalification of Medicines Programme (whichever date is earlier). This procedure forms part of the maintenance of the prequalified product, and is called Requalification.
The objective of this quality review submission is to enable WHO Prequalification of Medicines Programme to requalify the product based on an assessment of the data and information submitted by the holder of a prequalified product, which includes verification of the acceptability of the product meeting current norms and standards, and assessment of consistency of the quality of the prequalified FPP, and its manufacturing process(es) over the identified period.
The draft Guideline on the requalification of prequalified products (see related link below) was adopted during the 44th meeting of WHO's Expert Committee on Specifications for Pharmaceutical Preparations held during October 2009. The guideline is attached as Annex 1 to the model letter below. The model letter outlines the items to be submitted by the applicant for the purpose of requalification of a prequalified medicinal product dossier.
Model letter to the applicant regarding requalification
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