The “Documents for Comments” area serves as a space for stakeholders to engage with SAHPRA’s regulatory processes. Your input is valuable as we strive to ensure transparency and inclusivity in our decision-making. Please take the time to review the documents and share your comments. Together, we can contribute to the continuous improvement of healthcare regulation in South Africa.
| Document Name | Description | Date Published | Comments Deadline date | Submit to | Comments Form | Document for Comment |
|---|---|---|---|---|---|---|
| SAHPGL-INSP-09 - Requests for Information Related to Selling of Medicines | This guideline represents the current approaches of the Authority with regard to the request for information related to the selling of medicines and may be amended when required. | 18 June 2024 | 31 August 2024 | Send email to: deon.poovan@sahpra.org.za | Download Form | Download Document for Comment |
| ZA-SAHPRA CTD eSubmission Specification | The CTD eSubmission Specification is a temporary solution for certain applications (e.g., Veterinary, Complementary) to be used while companies have time to implement an Electronic Common Technical Document (eCTD) solution. | 06 June 2024 | 03 July 2024 | Send email to: pratibha.sobrun@sahpra.org.za | Download Form | Download Document for Comment |
| SAHPGL-INSP-RC-04 – Guideline on Traceability of Health Products | 06 May 2024 | 30 June 2024 | Send email to: christelna.reynecke@sahpra.org.za | Download Form | Download Document for Comment |