- Mots-clés > Prequalification of Medicines Programme - WHO
- Mots-clés > prequalification of product - re-evaluation and re-inspections
- Mots-clés > prequalified product dossier
- Mots-clés > procedure for prequalification of pharmaceutical products
- Mots-clés > product dossier (PD)
- Mots-clés > requalification - prequalified dossiers
- Mots-clés > WHO-prequalified products - quality review
(2010; 6 pages)
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...