On 15 November 2021 the Minister of Health published a Notice under section 36(1) of the Medicines and Related Substances Act 101 of 1956 (“the Medicines Act”) effective from the date of publication for a period of twenty-four (24) months.

According to this Notice, the South African Health Products Regulatory Authority (“SAPHRA”) recommended to the Minister of Health to exclude any vaccine registered or authorized by the SAPHRA for use in the prevention of COVID-19 from the application of the requirements set out in section 22A(5) of the Medicines Act in so far as:

  • COVID-19 vaccines may also be sold by the National Department of Health (“the Department”); and
  • Such vaccines are only sold by the Department to a wholesaler or distributor that holds a license issued in terms of section 22C(1)(b) of the Medicines Act to act as a wholesaler or distribute such medicines, or a community or institutional pharmacy licensed by the Director General and recorded with the South African Pharmacy Council in terms of the Pharmacy Act 53 of 1974, or to a person or organization performing a health service authorised to acquire, possess, use or supply COVID -19 vaccines in terms section 22A(15) of the Medicines Act.

The link to this Notice can be found here: https://www.gov.za/documents/medicines-and-related-substances-act-exclusion-coronavirus-covid-19-vaccines-operation