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Covers listing prior acceptance with other regulators, author declarations on accuracy and non-misleading information, confirmation of documentation and GMP compliance aligned with WHO requirements, ICH Q7 GMP, and supplier/intermediate review. Includes commitments on WHO on-site inspections, timely contact updates, and nitrosamine risk assessment integration with CTD and APIMF reporting, plus confirmatory testing and mitigation when applicable.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/application-for-active-pharmaceutical-ingredient-master-file-apimf-procedure-application-details/166698/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/application-for-active-pharmaceutical-ingredient-master-file-apimf-procedure-application-details/166698.png","ImageObject",442,249,{"name":88,"@type":89},"วิน","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-28","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What must be declared in the submission declarations section?","Question",{"text":108,"@type":109},"The applicant confirms the information is accurate, not intentionally misleading, and not missing any details affecting compliance with WHO requirements. It also confirms the submitted APIMF meets the specified documentation requirements and that manufacturing and supplier sites operate in compliance with ICH Q7 GMP.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should previous acceptance of an APIMF be handled?",{"text":113,"@type":109},"If the APIMF document (current version) has been lodged with other medicines regulatory agencies, each acceptance must be listed separately in the table provided.",{"name":115,"@type":106,"acceptedAnswer":116},"What are the requirements for nitrosamines risk assessment?",{"text":117,"@type":109},"The applicant confirms a nitrosamines risk assessment was conducted and that results were integrated into the relevant CTD sections, with the risk assessment report appended to the APIMF. If a risk was identified, confirmatory testing must be undertaken; if nitrosamines are confirmed, risk mitigation measures must be applied.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},166698,1790165614,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":73},2336475104736,"https://ap-avatar.wpscdn.com/avatar/22000c4c5e0e5b17e70?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786591360781797222","\u0013 DOCPROPERTY  \"Report Title\"  \\* MERGEFORMAT \u0014 Application for\nActive Pharmaceutical Ingredient Master File (APIMF) Procedure\n\u0015Please complete each section of this application form electronically.\nApplication details\n\u000f\n\u000f\nPrevious acceptance of APIMF\nIf the APIMF document (current version) is lodged with other medicines regulatory agencies please list each separately in the table below.\n\u000f\nSubmission declarations\nI, the undersigned, on behalf of _________________________ (company name),\nDeclare that the information contained in this application form and in the submitted documents is accurate.\nConfirm that information in the application form and the submitted documents does not contain intentionally misleading information, nor has information been withheld that might affect the assessment of compliance with WHO requirements.\nConfirm that the submitted APIMF meets the documentation requirements specified on the website of the Prequalification Team: medicines.\nConfirm that the sites of manufacture specified in the submitted APIMF are operating in compliance with ICHQ7 GMP.\nConfirm that the API manufacturer has undertaken review of their API intermediate suppliers to determine that they are operating in compliance with ICHQ7 GMP.2\nAgree to permit WHO inspectors to undertake an on-site inspection at any time, either announced or unannounced, to confirm that the API manufacturing site; and or any associated intermediate, testing or contract manufacturing site, is manufacturing in compliance with WHO GMP.\nI confirm that changes to the contact person for this application will be communicated to PQTm in a timely manner.\nI confirm that a risk assessment for the presence of nitrosamines has been conducted for this API and that the risk assessment outcome has been integrated into the relevant CTD sections and the risk assessment report appended to the APIMF. In case a risk of presence of nitrosamines has been identified, I confirm confirmatory testing has been undertaken. In case the presence of nitrosamines has been confirmed, risk mitigation measures have been undertaken.\nName:\nSignature:  \t\tDate:\nPosition within company:\n\u000f\nApplication Checklist\nTo ensure a complete application, please use this checklist to verify that all required information has been prepared for submission.\nThe cover letter and CD/DVD should be sent to:\nWorld Health Organization\u000bWHO Prequalification Team: medicines\u000bMHP/RPQ/PQT Room 613\u000b20 Avenue Appia\u000b1211 Geneva 27\u000bSwitzerland\nOr\nVia a secure link to an online document repository.  The link should be sent in an email  to the following email address: \u0013 HYPERLINK \"mailto:APIassessment@who.int\" \u0014APIassessment@who.int\u0015  The Subject line of the emails should clearly indicate the application and the specific medicine procedure referred to. The date of receipt will be the date the file is successfully downloaded. If you have any questions regarding this please contact Dr Matthias Stahl, \u0013 HYPERLINK \"mailto:stahlm@who.int\" \u0014stahlm@who.int\u0015","cbCaitVzRjrUsZLR","https://ap.wps.com/l/cbCaitVzRjrUsZLR","docx",46747,6,"English","# Previous acceptance of APIMF\n# Submission declarations\n# Application Checklist","[{\"question\":\"What must be declared in the submission declarations section?\",\"answer\":\"The applicant confirms the information is accurate, not intentionally misleading, and not missing any details affecting compliance with WHO requirements. It also confirms the submitted APIMF meets the specified documentation requirements and that manufacturing and supplier sites operate in compliance with ICH Q7 GMP.\"},{\"question\":\"How should previous acceptance of an APIMF be handled?\",\"answer\":\"If the APIMF document (current version) has been lodged with other medicines regulatory agencies, each acceptance must be listed separately in the table provided.\"},{\"question\":\"What are the requirements for nitrosamines risk assessment?\",\"answer\":\"The applicant confirms a nitrosamines risk assessment was conducted and that results were integrated into the relevant CTD sections, with the risk assessment report appended to the APIMF. If a risk was identified, confirmatory testing must be undertaken; if nitrosamines are confirmed, risk mitigation measures must be applied.\"}]","Application for Active Pharmaceutical Ingredient Master File (APIMF) Procedure - Application details | DOCX",1788198215]