Archive
19 Feb Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration
This document is intended to provide clarification on the fees payable in terms of the Medicines and Related Substances Act, 101 of 1965, that have been gazetted on 12 February 2025 for applications for the renewal of the certificate of registration....
12 Feb Newly Gazetted Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act
This document is intended to provide communication to updated Regulations Regarding Fees Payable in Terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) have been gazetted on 12 February 2025 introducing a new fee dispensation....
07 Feb Revised Fees Regulation Update
This document is intended to provide communication on the revised Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)....
31 Jan Approval of a dosimetry service in South Africa
This guideline sets out the requirements for the approval of a dosimetry service to operate in South Africa and provide passive monitoring of radiation workers....
30 Jan Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix
This document is intended to provide an update on the document matrix to be utilised by all applicants submitting applications for the Renewal of the certificate of registration from 22 January 2025. The Document Matrix location is as follows: https://ectd.sahpra.org.za/ Reference is made to ZA-SAHPRA eCTD...
28 Jan Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant
This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines. Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...
28 Jan Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID‑19 Vaccines
Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID‑19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group Victoria Prudence Nambasa · Hannah May Gunter · Modupe Bamidele Adeyemo · Neetesh Yanish Bhawaneedin · Marc Blockman · George Tsey Sabblah ,...
22 Jan Regulatory Information Management System – Application Withdrawal
This communication is intended to provide an update to applicants on the process for the cancellation of registered health products in Specification 3.1 and as of 01 November 2024. Reference is made to ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information, July 2024,...
13 Dec Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)
This guideline provides the information to be supplied to SAHPRA when completing the form to report an adverse event for a medical device (including an IVD), it outlines the format and data requirements for reporting of an adverse event, using the Medical Device Adverse Event...