19 Nov Template – Seal Letter
Posted at 17:10h
in
This letter shows routine inspection was carried out at a premises....
Archive
19 Nov Template – Tech Unseal Letter
Posted at 17:07h
in
This letter grants permission to name of Technician of name of IB to remove the seal from the x-ray unit at the premises of the licence holder....
19 Nov Template – Unseal Letter
Posted at 16:58h
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This letter grants permission to the licence holder to remove the seal from the x-ray unit at the premises in the absence of the Radiation Inspector....
01 Jul Template of Amendment Schedule to APIMF Holder
Posted at 11:37h
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The template of Amendment Schedule to APIMF holder is for API suppliers to complete to indicate any changes in the APIMF....
22 May Letter of Permission from HCR
Posted at 12:02h
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To be printed on the letterhead of the Holder of the Certificate of Registration...
22 May Declaration of Sameness for Clones and Replicas
Posted at 11:59h
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To be printed on the letterhead of the proposed Holder of the Certificate of Registration...
14 May CEP Letter of Access Template
Posted at 11:29h
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The CEP Letter of access must be drafted on the latest approved SAHPRA letterhead...
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
in
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....