Communication to industry Archives - Page 10 of 23

01 Aug Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Posted at 14:17h in

This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines. The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...

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...

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....

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...

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...

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...

06 Jun ZA-SAHPRA CTD eSubmission Specification – Document for comment

Posted at 20:25h in

The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...

05 Jun Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders

Posted at 19:40h in

This document is intended to provide contact details for communicating reportable adverse events, as per Guideline SAHPGL-MD-03, as well as contact details for any Recalls and Market actions for medical devices (including IVDs). Reportable adverse events reports must be emailed to mdvigilance@sahpra.org.za and copy (cc) Puseletso.Mogano@sahpra.org.za...

28 May Communication to Industry – Implementation of Regulatory Information Management System – Update on Progress

Posted at 15:18h in

This communication is intended to provide an update on the progress of the Regulatory Information Management System (RIMS) deployment at the South African Health Products Regulatory Authority (SAHPRA)....

17 May Expression of Interest for Medical Device Registration Voluntary Feasibility Study

Posted at 09:33h in

SAHPRA intends to conduct a voluntary feasibility study for medical device registration to validate the proposed process for registration of medical devices. The medical device registration feasibility study is only for medical devices intended for human use and aims to provide an approach to benefit stakeholders,...

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