Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format

Communication to Industry – Implementation of Regulatory Information Management System – Responses to queries in eSubmission format

During the recent webinar engagements, we have had several applicants raise questions seeking clarity around the appropriate process to follow for submitting Responses to queries that have been shared by SAHPRA for their review, action and response – for either new medicine applications or variation applications.

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Document Number: HPA-15
Version: 3
Date Updated: 29/04/2024
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, HPA