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South Africa

Medicines and Related Substances Act, 1965

Exclusion of COVID-19 Vaccines From the Operation of Certain Provisions of the Act

Government Notice 1502 of 2021

Published in Government Gazette no. 45487 on 15 November 2021
Assented to on 5 October 2021
Commenced on 15 November 2021
[This is the version of this document from 15 November 2021.]

I, Dr M.J. Phaahla, Minister of Health, in terms of section 36(1) of the Medicines and Related Substances Act 101 of 1965 (the Act), and on the recommendation of the South African Health Products Regulatory Authority (the Authority) hereby exclude any vaccine registered, or authorised by the Authority for use in the prevention of COVID-19 (COVID-19 vaccine) from the requirements of section 22A(5) of the Act to the extent that—

(a)COVID-19 vaccines may also be sold by the National Department of Health; and

(b)such vaccines are only sold by the Department to a wholesaler or distributor that holds a licence issued in terms of section 22C(1)(b) of the Act to act as a wholesaler or distribute such medicines, a community or institutional pharmacy licensed by the Director-General and recorded with the South African Pharmacy Council, in terms of the Pharmacy Act, 1974 (Act No. 53 of 1974), or to a person or organisation performing a health service (including a health establishment), authorised to acquire, possess, use or supply COVID-19 vaccines in terms of section 22A(15) of the Act.

This Notice is effective immediately from the date of publication in government gazette for a period of twenty four (24) months.Dr M.J. Phaahla, MPMinister of Health

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History of this Government Notice

15 November 2021 this version

Published in Government Gazette no. 45487

Government Notice commences.
5 October 2021

Assented to by council.

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