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 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....
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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Letter of access for SAHPRA, in reference to APIMF record [APIMF number, if allocated]...
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This document has been archived....
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