Archive
01 Feb New Registration Validation Template for eCTD
Posted at 10:12h
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01 Feb SAHPRA Variation Validation Template for eSubmission
Posted at 10:10h
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01 Feb Validation Template For ECTD Variation Applications
Posted at 10:09h
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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 a variation application for a medicinal product for human use submitted in eCTD format. It is also used for follow-up...
01 Feb Outcome of Risk for Nitrosamine Investigation
Posted at 10:08h
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...01 Feb Notification Template 2 for Nitrosamine Confirmatory Testing
Posted at 10:05h
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...01 Feb Notification Template 1 for Nitrosamine Risk Evaluation
Posted at 10:04h
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...27 Jan Communication to industry on Clones and Replicas
Posted at 08:18h
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A clone is defined as an application submitted by the Innovator as a copy of its own product under a different proprietary name at any stage during the product life cycle. A replica is defined as a copy of an already registered generic product,...
27 Jan Communication to industry on metformin-containing medicines
Posted at 08:17h
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The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...