Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
(2010; 6 pages)

Resumen

In accordance with the provisions set out in section 12 (Maintenance of prequalification status) of the Procedure for prequalification of pharmaceutical products, holders of WHO-prequalified products should submit a quality review 5 years from the date of prequalification of the product, or when requested to do so by WHO Prequalification (whichever date is earlier)...

Re-evaluation, including re-inspections of manufacturing sites and contract research organizations (CROs), will be done at regular intervals, based on risk assessment, but at least once every 5 years...

 
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