Documentation checklist The following documents have been submitted together with this application form: Note: All documents must be provided for this application to be valid. A completed revised APIMF application form (Word) Yes and A signed and completed revised APIMF application form (PDF) Yes An amendment summary document introducing, explaining, discussing the Yes proposed changes in (Word or text-selectable PDF). not applicable If annual amendment notifications are included in the submitted application the documents as specified in the WHO Guidance on Amendments to an APIMF Yes submitted in support of a prequalified product (FPP) or prequalified active not applicable pharmaceutical ingredient (API) are available on request or at the time of inspection Open and restricted sections of the APIMF revised in fulfillment of the requirements under section 3.2.S of the WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for Yes the WHO Prequalification of Medicines Programme: quality part. (Refer to not applicable APIMF documentation requirements on website of the Prequalification Team: medicines website.) API-Quality Information Summary (API-QIS) For APIMFs that have an agreed upon API-QIS, the QIS should be revised and submitted. All revised details should be highlighted. To assist with rapid identification of changes, all revisions should be made in red font and obsolete Yes information struck through. No agreed QIS If there are no alterations required to the API-QIS then it does not need to be No change to QIS provided. If there is no agreed API-QIS then this document can be omitted. Declaration only for applications for amendment 1a. (delete section 6.1 if not – applicable) I declare that: No changes have been made to any detail of the originally accepted APIMF version and API continues to be supplied in accordance with these details. There are no changes to the originally agreed upon API-QIS and therefore a copy of the currently agreed API-QIS has not been included in this submission. The information submitted is true and correct.
Documentation checklist The following documents have been submitted together with this application form: Note: All documents must be provided for this application to be valid. A completed revised APIMF application form (Word) and A signed and completed revised APIMF application form (PDF) Yes Yes An amendment summary document introducing, explaining, discussing the proposed changes in (Word or text-selectable PDF). Yes not applicable If annual amendment notifications are included in the submitted application the documents as specified in the WHO Guidance on Amendments to an APIMF submitted in support of a prequalified product (FPP) or prequalified active pharmaceutical ingredient (API) are available on request or at the time of inspection Yes not applicable Open and restricted sections of the APIMF revised in fulfillment of the requirements under section 3.2.S of the WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part. (Refer to APIMF documentation requirements on website of the Prequalification Team: medicines website.) Yes not applicable API-Quality Information Summary (API-QIS) For APIMFs that have an agreed upon API-QIS, the QIS should be revised and submitted. All revised details should be highlighted. To assist with rapid identification of changes, all revisions should be made in red font and obsolete information struck through. If there are no alterations required to the API-QIS then it does not need to be provided. If there is no agreed API-QIS then this document can be omitted. Yes No agreed QIS No change to QIS Declaration – only for applications for amendment 1a. (delete section 6.1 if not applicable) I declare that: No changes have been made to any detail of the originally accepted APIMF version and API continues to be supplied in accordance with these details. There are no changes to the originally agreed upon API-QIS and therefore a copy of the currently agreed API-QIS has not been included in this submission. The information submitted is true and correct.
66%20Application%20new%20version%20APIMF_version_May2017.docx