A number of documents have been published by the South African Health Products Regulatory Authority (SAHPRA) calling for inputs and comments to be sent to regulatorycomplianceunit@sahpra.org.za by the 8 October 2021 deadline.
- Guideline for release of import health products at port of entries: This guideline aims to assist importers, agents, shippers, travellers and visitors on the relevant documents and processes required for imported health products (medicines, medical devices and complementary health products) into South Africa.
- Guidelines for Advertisement of Medicines Health Products and Medical Devices: This guideline aims to assist with advertising requirements of medicines and health products in South Africa.
- Guideline for Disposal of Unwanted Unwholesome Pharmaceutical Products: This guideline aims to provide guidance to all stakeholders handling health products, medical devices, medicines registered or authorised by SAHPRA to ensure safe disposal of unwanted/ unwholesome health products and prevent their re-entry into the supply chain.
The comment deadline on Health Technology Assessment (HTA) system being proposed has been extended to 18 October 2021. There is also an Essential Medicines List (EML) National Appeals Policy.
Furthermore, the below calls for comment have also been gazetted with a comment deadline of 17 December 2021.
- Regulations to the Constitution of the Medical and Dental professions Board: – Changes have been drafted to the definitions, constitution of the board, repeal of laws and short title of the regulations relating to the constitution of medical and dental professions boards.
- Regulations defining the scope of the profession of oral hygiene: Changes have been drafted for dental assisting, dental therapy and oral hygiene in the schedule of the regulations defining the scope of the profession of oral hygiene.
Regulations relating to fees payable to council under the Pharmacy Act: Changes have been drafted to the definitions, fees payable
