Archive
11 Jul ECTD Validation And Technical Screening For Renewals
Posted at 10:57h
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The Validation Template is used on receipt of an application to verify that all required information has been supplied to the South African Health Products Regulatory Authority (SAHPRA) in order to evaluate an application for the renewal of the certificate of registration of a medicinal...
03 May Template for Module 2.3_Quality Overall Summary (QOS)
Posted at 14:24h
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This document is for use of all products including Biologics and veterinary products, where the information is not applicable for the specific molecule; indicate "N/A". Veterinary medicine applicants are advised to also refer to the VICH guidelines....
03 May Template for Module 2.3_Quality Information Summary (QIS)
Posted at 14:22h
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This document is for use of all products including Biologics and veterinary products....
13 Apr Quality And Bioequivalence Verified Review Template
Posted at 11:36h
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This template has been updated to conform to the new SAHPRA document format....
14 Oct Template of Standardised Content of Letter of Access
Posted at 16:55h
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The template of Standardised Content for Letters of Access is populated by the applicant to authorise SAHPRA to review the APIMF record for new registration applications or variations....
20 Sep Residue Overall Summary (ROS)
Posted at 17:57h
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Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species....
01 Sep Veterinary Clinical Trial Application Template
Posted at 11:01h
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This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...