and/or the manufacturer is not able to, or fails to, implement any corrective actions that WHO may require within a specified deadline.the product does not meet the acceptance criteria for the performance evaluation.it does not meet WHO prequalification requirements or if the manufacturer is not able to, or fails to, provide the required or requested information within a specified deadline and/or.Failure to comply with prequalification comittments within agreed deadlines will result in the product being delisted from the WHO List of Prequalified In Vitro Diagnostics. Such a “commitment to prequalification” will be reflected in the WHO prequalification public report and verified during re-inspection. In certain cases, WHO may permit the manufacturer to correct specific nonconformities after prequalification provided that the manufacturer commits in writing to correct them by an agreed upon deadline. WHO will not undertake any further action) until a corrective action plan has been submitted by the manufacturer and accepted by WHO. Generally, prequalification assessment suspended (i.e. The manufacturer can submit no more than two corrective action plans but only one amendment to the original product dossier will be permitted. responses to be provided to comments, documentation and/or data that is missing and needs to be provided), and deadlines for their submission, must be provided by the manufacturer to WHO. Thereafter, a corrective action plan that details the amendments required (i.e. Dossier deficienciesĪny deficiencies in the documentation submitted and/or in the data that are identified in the product dossier review is communicated by WHO in writing to the manufacturer. Assessment of product dossiers is conducted in accordance with standard operating procedures that ensure uniformity in evaluation and timeliness of assessment activities. Information submitted in a product dossier is assessed after submission of proof of payment of the applicable prequalification assessment fee. Complaints handling by the manufacturer.Changes requiring a new prequalification application.Benefits of WHO prequalification of IVDs and MCDs.WHO Public Inspection Reports (WHOPIRs).List of Prequalified Vector Control Products.About Vector Control Products Prequalification.Vaccine information by disease category.Prequalified vaccine annual report (PQVAR).Vaccines Eligible for WHO Prequalification.Support to Manufacturers, CROs and QCLs.Pilot Prequalification of Biotherapeutic Products.WHO medicines prequalification guidance.
#Dossier reviews registration
Accelerated registration of FPPs approved by SRAs.Accelerated registration of prequalified FPPs.Collaborative Procedures for Accelerated Registration.Post-prequalification Procedures & Fees: APIs, FPPs, QCLs.Prequalification Procedures & Fees: FPPs, APIs & QCLs.FPPs and APIs Eligible for Prequalification ("EOIs").Collaborative Procedure for Accelerated Registration.Post-prequalification Procedures: Prequalified MCDs.Post-prequalification Procedures & Fees: Prequalified IVDs.Prequalification Procedures & Fees: MCDs.Prequalification Procedures & Fees: IVDs.About In Vitro Diagnostic & Male Circumcision Device Prequalification.Prequalification guidance for manufacturers.Post-prequalification Procedures & Fees.Laboratory Accreditation for Product Testing.Product Testing Support for Manufacturers.WHO Catalogue of Prequalified Immunization Devices.About Immunization Devices Prequalification.
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