Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers

01 Aug Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers

Posted at 14:14h in

This document is intended to provide communication to The Holder of Certificate of Registration for Codeine containing products.   The Advisory Clinical Committee (ACC) reviewed data submitted by HCRs to support the continued use of codeine in children under 12 years and concluded that there is evidence...

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23 Jul Communication to Industry – FAQs on Active Pharmaceutical Ingredient

Posted at 14:07h in

This FAQs document is intended to provide communication to the API suppliers to assist them with adequately addressing the most common queries received by SAHPRA....

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23 Jul Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations

Posted at 10:43h in

This communication provides guidance which represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on this topic. It does not establish any rights for any person and is not binding on SAHPRA or the public. You can use an alternative approach...

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23 Jul CTD Checklist

Posted at 10:39h in

The checklist must be included in submissions that include variations for CTD conversions. This checklist should also be included as an annexe to the cover letter for the baseline sequence when converting from eSubmission to eCTD....

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23 Jul Z-Code Request Form

Posted at 10:37h in

Populate this information on a document that includes your company letterhead....

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16 Jul Guideline on Co-Applicancy

Posted at 12:01h in

This guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than...

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09 Jul B-BBEE Policy for Issuance of Licences – for further comments

Posted at 13:16h in

Stakeholders are hereby invited to provide further comments to the draft SAHPRA’s Broad-Based Black Economic Empowerment Policy for issuance of new and the renewal of licences as per section 22C of the Medicines Act. To expedite the process, the stakeholders are requested not repeat the...

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09 Jul Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use

Posted at 11:58h in

This document is intended to provide communication to applicants on system updates regarding the Regulatory Information Management System (RIMS) Portal and the Digital Variations Portal (DVP).   SAHPRA’s digital transformation has progressed as planned with submissions via the sFTP for new product applications, all variations, and renewals...

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08 Jul GSK DHCPL – Risk of DRESS associated with use of aciclovir and valaciclovir-containing medicines

Posted at 13:29h in

GlaxoSmithKline (GSK) South Africa, in collaboration with SAHPRA, would like to inform healthcare professionals about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of aciclovir and valaciclovir-containing medicines....

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06 Jul Recommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines – Dr Reddy’s Laboratories

Posted at 14:04h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Dr. Reddy’s Laboratories (Pty) Ltd would like to draw your attention to the recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (including potential genotoxic metabolites)....

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