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Guidelines on the requalification of prequalified dossiers
1. Introduction:
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).
Section 12 of the above-mentioned guidelines states that:
WHO will furthermore arrange for the products and manufacturing sites included in the list to be re evaluated at regular intervals. If, as a result of this re-evaluation, it is found that a product and/or specified manufacturing site no longer complies with the WHO-recommended standards, such products and manufacturing sites will be removed from the list. Failure of a manufacturer or applicant to participate in the re-evaluation procedure will also lead to removal from the list.
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.
Re-evaluation, including re-inspections, shall also be performed:
• if any fraud or omissions by the applicant, manufacturer(s) of a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API), or CROs in the initial assessment procedure or during the follow-up activities, becomes evident; and
• if WHO or any United Nations agency considers that a batch or batches of supplied prequalified pharmaceutical products are not in compliance with the specifications which were found to be applicable upon prequalification.
Requalification will be applicable to multisource FPPs (generics) where the full dossiers have been submitted, assessed and prequalified by WHO. Renewal of marketing authorization for products that have been listed by WHO based on approval by a stringent regulatory agency (SRA) remains the responsibility of the relevant SRA.
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WHO TRS (Technical Report Series) 957, 2010 Annex 6:
