[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-200090-105":53,"doc-detail-200090-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","a-administrative-validation-ectd-renewal-validation-template","A - ADMINISTRATIVE VALIDATION - eCTD Renewal Validation Template","","eCTD renewal administrative and business validation template for SAHPRA medicinal product registration. Used upon receipt of an eCTD-format renewal application to confirm required fields, documents, and compliance checks are complete before evaluation. Includes compliance criteria for correct renewal phase and quarter, FTP naming convention, Module 1.0 and 1.2.1 documents, signed declarations, MD5 checksum, and validation template requirements. 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The applicant must ensure all relevant fields are completed.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What changes are required for products registered in 2017 or earlier when using eCTD?",{"text":113,"@type":109},"A full eCTD baseline (0000) submission is required, if the dossier has not yet been converted to eCTD. For the baseline sequence, submit only Sections A.1; A.3 and C.",{"name":115,"@type":106,"acceptedAnswer":116},"What must the applicant complete in the compliance check to prevent rejection?",{"text":117,"@type":109},"The applicant must tick YES for included required documents or tick N/A when not required. Any question not ticked will be at risk of rejection.","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},200090,1790385813,{"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":79,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":30,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":140},687207024478,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate an application for the renewal of registration of a medicinal product for human or veterinary use submitted in eCTD format. The applicant must ensure that all relevant fields are completed.\nFor products registered in the year 2017 and dating further back, a full eCTD baseline (0000) submission in line with the General Information guideline for registration will be required (only if the dossier has not yet been converted to eCTD): Complete and submit only Sections A.1; A.3 and C for the baseline sequence.\nFollow-up sequences (related to the renewal application): Complete and submit only Sections A.1 A.3; B; D and E.\nA\tADMINISTRATIVE VALIDATION\nA.1\tCOMPLIANCE CHECK\nApplicant to fill in the table below as per the application M1.0\nProduct information\nApplicant name\n{Licensed Name}\nMaster product application number/s\nDuplicate product application number/s\nClone/replica product application number/s\neCTD sequence number\nMaster product proprietary name/s\nDuplicate product proprietary name/s\nClone/replica product proprietary name/s\nProduct strengths\nDosage form\nAPI/s\nDate of letter of application\nDate of receipt (SAHPRA use only)\n\u000f\nApplicant to indicate using a tick (✔) in the YES column if the required documents have been included or tick (✔) N/A if not required for specific submission. Any question not ticked will be at risk of rejection.\nDossier Information\nYes\nN/A\n1a\nIs the application submitted within the correct Phase and quarter as per the renewal roadmaps schedule?\n1b\nHave the following documents in eCTD format been submitted?\n1c\nIs the correct FTP file naming convention followed and unit clearly indicated?\n2a\nLetter of Application (Module 1.0)\nHas the virus check statement been included?\nDoes the virus check statement indicate that the submission is virus-free?\nDoes the letter of application clearly indicate different strengths and/or duplicates and/or clones/replicas?\n2b\nApplication Form (Module 1.2.1)\nIs Module 1.2.1(c) signed by the authorised pharmacist and dated?\nHas a separate Module 1.2.1 been submitted for each strength if different strengths are applied for?\nHas a separate Module 1.2.1 been submitted for each duplicate?\nHas a separate Module 1.2.1 been submitted for each clone/replica?\n2c\nElectronic copy declaration (Module 1.2.2.4)\n2d\nValidation template (Module 1.8)?\n2e\nMD5 checksum – identifiable, signed and dated\n2f\nTechnical Validation Report (indicating valid submission and justification for any Best Practice criteria that are not met where relevant, attached to the report)\nValidation tool used and version stated?\nA.2\tTECHNICAL VALIDATION\nSAHPRA use only.\nApproved\tImport into the reviewing system and notify applicant of successful technical validation.\nRejected\tNotify the applicant of rejection with the reasons \u000f\nA.3\tBUSINESS VALIDATION\nApplicant to indicate using a tick (✔) in the YES column if the required documents have been included or tick (✔) N/A if not required for specific submission.  Any question not ticked will be at risk of rejection.\nDossier Information\nYes\nN/A\n1\nAre the following modules included in the eCTD?\n1a\nLetter of Application (Module 1.0)\nIs the letter of application electronically rendered or OCR scanned?\n1b\nApplication Form (Module 1.2.1)\nIs the application form electronically rendered or OCR scanned?\nHas a separate Module 1.2.1 been submitted for each strength (and duplicates) if different strengths or duplicates are applied for?\nApplication Form, inclusive of up-to-date Variation History:\nTabular summary of the types of variations notified to, approved by and still pending with SAHPRA for the product, together with the respective dates of approval, if applicable.\n1c\nElectronic copy declaration (Module 1.2.2.4)\n1d\nPI and PIL (Module 1.3)\nIs the Professional Information (PI) and Patient Information Leaflet (PIL)PI and PIL from 5 years prior ","cbCaibupt5uMm9NO","https://ap.wps.com/l/cbCaibupt5uMm9NO","docx",111138,"English","# A ADMINISTRATIVE VALIDATION\n## A.1 COMPLIANCE CHECK\n## A.2 TECHNICAL VALIDATION\n## A.3 BUSINESS VALIDATION","[{\"question\":\"What is the purpose of the Validation Template for SAHPRA eCTD renewals?\",\"answer\":\"It verifies that all required information and documents have been supplied to SAHPRA so the renewal application can be evaluated. The applicant must ensure all relevant fields are completed.\"},{\"question\":\"What changes are required for products registered in 2017 or earlier when using eCTD?\",\"answer\":\"A full eCTD baseline (0000) submission is required, if the dossier has not yet been converted to eCTD. For the baseline sequence, submit only Sections A.1; A.3 and C.\"},{\"question\":\"What must the applicant complete in the compliance check to prevent rejection?\",\"answer\":\"The applicant must tick YES for included required documents or tick N/A when not required. Any question not ticked will be at risk of rejection.\"}]","A - ADMINISTRATIVE VALIDATION - eCTD Renewal Validation Template | DOCX",1788507856,6]