Documents A to Z

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IMD-SOP-11 REMOVING A PREQUALIFIED PRODUCT FROM THE IMD-PQS DATABASE PDF

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IMD-SOP-13 Obtaining feedback in the performance of an IMD-PQS product PDF

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IMD-SOP-13 OBTAINING FEEDBACK ON THE PERFORMANCE OF AN IMD-PQS PRODUCT PDF

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IMD-SOP-14 AUDITING A LABORATORY FOR IMD-PQS ACCREDITATION PDF

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IMD-SOP-15 REVIEWING AN UNSOLICITED TEST REPORT FOR AN IMD-PQS PDF

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IMD-TP-01a Standard format for a performance specification PDF

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IMD-TP-01b Online Resources PDF

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IMD-TP-02a Standard letter A - Notification of minor specification changes PDF

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IMD-TP-02b Standard letter B - Notification of major specification changes PDF

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IMD-TP-03a Standard letter A - Notification of specification withdrawal PDF

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IMD-TP-04a Standard format for a type-examination protocol PDF

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IMD-TP-04a Standard format for a type-examination protocol PDF

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IMD-TP-04b Standard format for a type-testing protocol PDF

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IMD-TP-04b Standard format for a type-testing protocol PDF

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IMD-TP-04c Standard format for a quality assurance protocol PDF

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IMD-TP-04c Standard format for a quality assurance protocol PDF

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IMD-TP-05a Standard letter A -Notification of minor changes to verification protocol PDF

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IMD-TP-05b Standard letter B -Notification of major changes to verification protocol PDF

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IMD-TP-06a Standard letter A - Notification verification protocol withdrawal PDF

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IMD-TP-07a Standard email request for reference PDF

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IMD-TP-07b Evaluation checklist PDF

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IMD-TP-07c Example format for an IMD-PQS-accredited test laboratory data sheet PDF

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IMD-TP-08a Email to request up-to-date information from a PQS accredited laboratory PDF

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IMD-TP-08b Laboratory re-accreditation checklist PDF

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IMD-TP-08c Testing log - all PQS testing and_or evaluation PDF

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IMD-TP-09a Standard letter A - Invitation to apply for prequalification PDF

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IMD-TP-09b Standard letter B - Prequalification information pack PDF

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IMD-TP-09c Standard letter C - Request for missing information PDF

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IMD-TP-09d Standard letter D - Evaluation notification PDF

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IMD-TP-09e Standard letter E - Rejection PDF

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IMD-TP-09f Standard letter F - Acceptance PDF

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IMD-TP-10a Standard letter A - Notification of problems identified during product re-evaluation PDF

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IMD-TP-10b Standard letter B - Notice of suspension of prequalification status PDF

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IMD-TP-10c Model format for product re-evaluation report PDF

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IMD-TP-11a Standard letter A - Notification of product removal PDF

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IMD-TP-13a Data entry format for electronic reporting system DOCX

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IMD-TP-13a Data entry format for electronic reporting system.pdf PDF

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IMD-TP-13b Model format for a Feedback Schedule form PDF

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IMD-TP-13b Model format for a Feedback Schedule form DOCX

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IMD-TP-13c Model format for Annual Feedback Summary form DOCX

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IMD-TP-13c Model format for Annual Feedback Summary form.pdf PDF

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IMD-TP-13d Model Product Alert form DOCX

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IMD-TP-13d Model Product Alert form PDF

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IMD-TP-13d Model Product Alert form DOCX

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IMD-TP-14a Exemplar questionnaire PDF

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IMD-TP-14b Exemplar timetable PDF

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IMD-TP-15a Provisions for evaluators of product dossiers PDF

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IMD-TP-15b Evaluation checklist PDF

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Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF

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Introducing solar-powered vaccine refrigerator and freezer systems PDF

Recently Updated Documents

WHO IMD-PQS Key web links (for Partners)

Q & A Change Request for WHO PQ and EUL IVDs (PQDx_463 June 2025)

ePQS – External Guidance – IVD Post-PQ Change Application

ePQS - External Guidance – Performance Evaluation Laboratory Application

WHO EUL Public Report for Xpert Mpox, (MPXV-12646-070-00)

WHO Technical Report Series Location

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found in the guidelines section of the WHO web pages dealing with quality assurance of medicines. The guidelines most relevant to WHO medicines prequalification are listed and accessible on the WHO Technical Report Series page.