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The following SAHPRA Guidelines have been published on the SAHPRA website:
- Guideline 7.02: Complementary Medicines - Roadmap and Transitional Arrangements (March 2021 - version 2.2) [for implementation]
- Guideline 7.04: Complementary Medicines - Health Supplements, Annexures M and N (March 2021 - version 4.1) [published for public comment by 30 June 2021]
- Guideline 7.06: Complementary Medicines - Guidelines on Specified Substances; Annexure 4: Cannabidiol (CBD) (March 2021 - version 3.1) [published for public comment by 30 June 2021]
- Notice to Stakeholders: Guidelines on Specified Substances; Annexure 4: Cannabidiol (CBD) (23 March 2021)
- Comment Template: SAHPRA CM Guidelines
All comment related to items 2 and 3 may be submitted online by the prescribed deadline. The comment submission area and all documents may be downloaded from Category D Medicines - Guidelines - Documents for Download.
In order to provide greater guidance, improved structure and version control, the 3D Product List template has been amended and uploaded for implementation.
Please take note of the following amendments:
- COLUMN A: The Version Number of the product list is indicated in the spreadsheet document in the very first cell. The number on the sheet should align with the identified current version in use. A permanent indication of the current valid version of the 3D Product List is indicated in the Footer of the website. In order to avoid any delays, applicants are requested to ensure that, prior to final submission, the version submitted matches the version indicated to currently be in use.
- COLUMN I: Heading amendment. The quantities reflected per ingredient should match the dosage form/unit used i.e.: per tablet, per capsule, per 5 ml, and indicated as such.
- COLUMN I: Expanded guidance for cell notes (when hovering over the header cell) indicating that scheduled substances (>S1) in respect of Discipline-specific substances should be identified by an * and the appropriate schedule in brackets.
- COLUMN J: Additional information added to the 3D product list which provides space for applicants to provide any information which the applicants regard as being confidential or explanatory in relation to the Ingredients column (Column I). This column is optional. Information provided in this column will be reviewed and not necessarily included in the final product list version unless determined otherwise.
- COLUMN N: Amended heading.
Annexure B applications in terms of Guideline 7.04 may now be made online. This may be found by going to Applications - Health Supplements-Annexure B Application.
Please note: these applications are only relevant for Annexures of Guideline 7.04 that are implemented and not for Annexures yet to be published for public comment.
New versions of SAHPRA Guidelines related to Category D (Complementary Medicines) have been published on www.sahpra.org.za. These documents are also provided for easy reference on SAHPRA CM by clicking here.