[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-174220-en":3,"doc-seo-174220-105":30,"detail-sidebar-cat-1-en-105":92},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":11,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},174220,962075114101,"Seraphina","https://ap-avatar.wpscdn.com/avatar/e000253a75eb197efd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1780044092746381165",1,17,"Forms","Administrative Validation - New Registration eSubmission Validation Template","Administrative validation template for eSubmission of a medicinal product for human use submitted to SAHPRA. It ensures required information and documents are complete before assessment of new registration and any follow-up sequences. The template defines which sections must be completed for the sequence type (new application, follow-up, baseline) and guides the applicant to complete compliance, technical screening, business validation, and technical verification steps using tick-based status fields, with motivations for any “NO” responses.","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 new registration of a medicinal product for human use submitted in eSubmission format. It is also used for follow-up sequences that may be required for the new registration. The applicant must ensure that all relevant fields are completed.\nSequence 0000 (new application for registration): Complete Sections A.1, A.3, B, C, D and E\nFollow-up sequences (related to the new registration): Complete and submit only Sections A.1 and A.3\nBaseline sequence: Complete and submit only Sections A.1 and A.3\nA\tADMINISTRATIVE VALIDATION\nA.1\tCOMPLIANCE CHECK\nApplicant to fill in the table below as per the application M1.0\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.\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.\nMotivation for deviation from the validation requirements (use the numbering in the checklist to link comments to specific questions):\nApplicant:\nSAHPRA use only\nCompliant\tContinue with technical screening\nNon-compliant\tErrors identified during the content check must be resolved by the applicant through the submission of a new eSubmission sequence\n\u000f\nB\tTECHNICAL SCREENING (INSPECTORATE)\nApplicant to indicate using a tick (✔) in the YES column if the required documents have been included. If ticking (✔) NO, provide a motivation in the comments section, referencing the question number.\nComments if any answer is ‘NO’ (use the numbering in the checklist to link comments to specific questions):\nApplicant:\nSAHPRA use only\nCan the application proceed with technical screening?\u000f\nC\tTECHNICAL VERIFICATION (MEDICINES EVALUATION AND RESEARCH – ME&R)\nApplicant to indicate using a tick (✔) the proposed ME&R evaluation pathway.\nC.1\tQUALITY\nApplicant to indicate using a tick (✔) in the YES column if the required documents have been included. If ticking NO, provide a motivation in the comments section, referencing the question number. Tick N/A if not applicable for this application.\nApplicant to complete Section 1 for each API in the product you are applying for. Please replace \u003C\u003CAPI name>> with the name of the API. Additional table(s) for Section 1 can be duplicated if necessary by copying and pasting.\n\u000f\nComments if any answer is ‘NO’ (use the numbering in the checklist to link comments to specific questions):\nApplicant:\nSAHPRA use only\nCan the application proceed to evaluation?\u000f\nC.2\tBIOEQUIVALENCE\nApplicant to indicate using a tick (✔) in the YES column if the required documents have been included. If ticking NO, provide a motivation in the comments section, referencing the question number. Tick N/A if not applicable for this application.\n\u000f\nComments if any answer is ‘NO’ (use the numbering in the checklist to link comments to specific questions):\nApplicant:\nSAHPRA use only\nCan the application proceed to evaluation?\u000f\nC.3\tFOREIGN REGULATORY STATUS\nPlease see SAHPRA’s 2.02 Quality and Bioequivalence Guideline for the full list of recognised regulatory authorities, as well as for more information on reliance.\nApplicant to indicate using a tick (✔) in the YES column if the required documents have been included. If ticking NO, provide a motivation in the comments section, referencing the question number. Tick N/A if not applicable for this application.\nComments if any answer is ‘NO’ by the applicant (use the numbering in the checklist to ","cbCaiiMJT6mFXNzW","https://ap.wps.com/l/cbCaiiMJT6mFXNzW","docx",113684,22,"English","en",105,"# Administrative Validation\n## Compliance Check\n## Technical Validation\n## Business Validation\n## Technical Screening (Inspectorate)\n## Technical Verification (ME&R)\n### Quality\n### Bioequivalence\n### Foreign Regulatory Status\n## Technical Screening (Pre Clinical and Clinical)\n## Technical Screening (Names and Scheduling)","[{\"question\":\"What is the purpose of the administrative validation template in SAHPRA eSubmission?\",\"answer\":\"It verifies that all required information and supporting documents have been provided to SAHPRA so the application for new registration of a medicinal product for human use can be evaluated. It is also used for any required follow-up sequences.\"},{\"question\":\"Which sections must be completed for a sequence 0000 new registration application?\",\"answer\":\"Complete Sections A.1, A.3, B, C, D and E.\"},{\"question\":\"How should the applicant respond if a compliance or screening question is not met?\",\"answer\":\"Use the tick (✔) in the relevant YES/NO field. For any response marked “NO,” provide a motivation in the comments section referencing the question number, and ensure required errors are resolved through a new eSubmission sequence when non-compliant.\"}]","Administrative Validation - New Registration eSubmission Validation Template | DOCX",1788311277,8,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":87,"head_meta":89,"extra_data":91,"updated_unix":28},"administrative-validation-new-registration-esubmission-validation-template","",{"@graph":36,"@context":86},[37,54,69],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":50},"https://docshare.wps.com/template/forms/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/administrative-validation-new-registration-esubmission-validation-template/174220/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-04","2026-09-02",true,{"@type":66,"interactionType":67,"userInteractionCount":11},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"What is the purpose of the administrative validation template in SAHPRA eSubmission?","Question",{"text":76,"@type":77},"It verifies that all required information and supporting documents have been provided to SAHPRA so the application for new registration of a medicinal product for human use can be evaluated. It is also used for any required follow-up sequences.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"Which sections must be completed for a sequence 0000 new registration application?",{"text":81,"@type":77},"Complete Sections A.1, A.3, B, C, D and E.",{"name":83,"@type":74,"acceptedAnswer":84},"How should the applicant respond if a compliance or screening question is not met?",{"text":85,"@type":77},"Use the tick (✔) in the relevant YES/NO field. 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