South Africa

Medicines and Related Substances Act, 1965

Exclusion of Schedule 2, Schedule 3 and Schedule 4 Substances from the Operation of Certain Provisions

Government Notice R481 of 2020

  • Published in Government Gazette no. 43260 on 30 April 2020

  • Assented to on 24 April 2020

  • Commenced on 30 April 2020

  • [Up to date as at 30 April 2020]

[This notice was published again as Government Notice 514 of 2020 on 7 May 2020.]
I, Dr Zwelini Lawrence Mkhize, the Minister of Health, in terms of section 36(1) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) (the Act), and on the recommendation of the South African Health Products Regulatory Authority, hereby exclude Schedule 2, Schedule 3 and Schedule 4 substances from the requirement in section 22A(6)(f) of the Act that such substances may be dispensed for no longer than six months:Provided that Schedule 2, Schedule 3 and Schedule 4 substances may not be dispensed for a period longer than twelve (12) months from the date of issue of a prescription issued by an authorised prescriber, in accordance with regulation 33 of the General Regulations made in terms of the Act (the Regulations), where the date of issue of the prescription is:(a)up to six (6) months before the date of publication of this notice, in which case additional repeats may be issued for a period not exceeding six months, and in accordance with the original prescription in order to ensure that therapy is not disrupted, if the person dispensing the prescription is satisfied that an authorised prescriber initiated the therapy, with the intention that the therapy be continued, and that the particulars of such sale are recorded in a prescription book or permanent record in terms of regulation 35 of the Regulations; or(b)on or six (6) months after the date of publication of this Notice.This exemption shall be effective immediately for a period not exceeding eighteen (18) months from the date of signature of this Notice.Dr Zwelini Lawrence Mkhize, MPMnister of Health

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