Corenza-c® Effervescent Tablets (C661 (Act 101/1965)): Amendment to Product Labelling – Not to Be Used in Children Under 12 Years of Age

15 Oct Corenza-c® Effervescent Tablets (C661 (Act 101/1965)): Amendment to Product Labelling – Not to Be Used in Children Under 12 Years of Age

Posted at 11:05h in

Adcock Ingram Limited, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the amended product labelling for Corenza-C® Effervescent Tablets to align with the recommended contraindicated use of aspirin in children under the age of 12 years...

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14 Oct Annual Report (2024/2025)

Posted at 09:06h in

SAHPRA's Annual Report allows for transparency, accountability, as well as a comprehensive view of the entity’s performance and strategic direction....

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09 Oct SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information

Posted at 18:02h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important...

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03 Oct Valproate-containing Medicines – Potential Risk of Neurodevelopmental Disorders in Offspring of Fathers Treated With Valproate in the Three Months Prior to Conception

Posted at 10:31h in

The document is a Dear Healthcare Professional (DHCP) letter informing healthcare professionals about the risk of neurodevelopment disorders in children born to fathers exposed valproate valproate-containing medicines three months before conception....

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03 Oct Signal Notification/ Follow-up Form

Posted at 10:08h in

The purpose of the form is to guide SAHPRA’s holders of certificates of registration about the details required and elements to be considered in the process of signal notification and follow-up. This form should be used to notify signals and Follow-Up information on signals according...

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03 Oct Communication to Industry – Summary of Medicine Safety Regulatory Decisions (PV04-2023/24)

Posted at 08:56h in

This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during January – March 2023. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are...

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01 Oct Traceability Guideline – Implementation Roadmap

Posted at 14:35h in

Dear Applicants, This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels....

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01 Oct Guideline on Traceability of Health Products

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

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29 Sep Communication to Industry – SAHPRA Online Directory Update

Posted at 16:13h in

The SAHPRA OTC Online Directory has been operational for some time. As outlined in the OTC Toolkit, it is mandatory to include the required lock-ins on all Schedule 0–2 promotional and advertising materials....

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29 Sep Communication to Industry – Pilot: Clinical Trial Applications Electronic System

Posted at 15:48h in

This communication is issued in view that SAHPRA has embarked on a process to digitalise its business processes and need to pilot the electronic process. The pilot is planned for new medicinal clinical applications for the month of October 2025, with the official launch of...

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