MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965: EXCLUSION OF COVID-19 VACCINES FROM THE OPERATION OF CERTAIN PROVISIONS OF THE ACT
Notice Title: Medicines and Related Substances Act 101 of 1965 (“MRSA”): Exclusion of COVID-19 vaccines from the operation of certain provisions of the MRSA
Government Notice: GN 1502 in GG 45487 on 15 November 2021
Commencing date: 15 November 2021
The Minister of Health (“the Minister”), in terms of section 36(1) of the MRSA, and on the recommendation of the South African Products Regulatory Authority (“the Authority”) excludes 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 MRSA to the extent that –
- COVID-19 vaccines may be sold by the Department of Health; and
- 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 MRSA to act as a wholesaler or distribute such medicines, a community or institutional pharmacy licenced by the Director-General and recorded with the South African Pharmacy Council, 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 MRSA.
The Notice is effective immediately from the date of publication in government gazette for a period of twenty-four (24) months (i.e. 14 November 2023).
For a copy of the Government Gazette Notice click here.
How to ensure compliance at my operations?
Wholesalers or distributors of medicines, pharmacies or authorised health services (related to COVID-19 vaccines) may purchase vaccines from the Department of Health for a period of 24 months.
For assistance or queries please contact Corrie Potgieter at firstname.lastname@example.org.