Communication to industry Archives - Page 8 of 23

10 Mar Communication to Industry – Intention to Declare Medicines Compounded in terms of Section 14(4) Containing GLP-1or GLP-1/GIP Agonists Undesirable

Posted at 08:32h in

SAHPRA intends to declare medicines compounded in terms of Section 14(4) of the Medicines Act containing Glucagon-Like Peptide-1 (GLP-1) Active Components or a combination of Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide agonist (GIP) Active Components undesirable in terms of Section 23 of the Medicines...

27 Feb Implementation of the Regulatory Information Management System– Status updates on the SAHPRA Engagement Portal

Posted at 09:48h in

Reference is made to HPA15-2024/25, version 5 and version 6. This document serves to inform applicants about the upcoming launch of the SAHPRA Engagement Portal on 01 April 2025. SAHPRA wishes to thank applicants for the validation of data points and to re-iterate the significance of the...

19 Feb Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration

Posted at 14:12h in

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

Posted at 18:52h in

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

Posted at 17:04h in

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)....

30 Jan Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix

Posted at 09:28h in

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

Posted at 20:41h in

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...

22 Jan Regulatory Information Management System – Application Withdrawal

Posted at 11:40h in

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,...

06 Dec Introduction of Conditions for Veterinary X-Ray Licence Holders

Posted at 09:26h in

This document is intended to provide communication on conditions for Veterinary X-Ray Licence Holders. ...

25 Nov Absence of Border Medicines Control Technicians at the Ports of Entry on 29 November 2024

Posted at 14:10h in

The South African Health Product Regulatory Authority (SAHPRA) wishes to inform stakeholders that Border Medicines Control Technicians (BMCT) will not be physically present at the ports of entry on 29 November 2024 due to an Annual General Meeting at SAHPRA’s Head Office in Pretoria....

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