Government Notice No. 481 of 2020

Medicines and related Substances Act (101/1965) » Exclusion of Schedule 2, Schedule 3 and Schedule 4...

Title	Medicines and related Substances Act (101/1965) » Exclusion of Schedule 2, Schedule 3 and Schedule 4 Substances from the Operation of certain Provisions of the Act
Department	Health
Gazette	Regulation Gazettes, No. 43260 of 30 April, 2020, 2 page(s), 1.5Mb

GOVERNMENT NOTICE

STAATSKOERANT, 30 APRIL 2020                        No. 43260    3
                                                DEPARTMENT       F HEALTH
                                                           E

Health, Department of/ Gesondheid, Departement van
                    NO,                         DEPARTMENT OF HEALTH                          2020
          NO. R. 481                                                                             30 APRIL 2020
          R. 
                       EXCLUSION OF SCHEDULE 2, SCHEDULE 3 AND SCHEDULE 4 SUBSTANCES
                        FROM THE OPERATION OF CERTAIN PROVISIONS OF THE MEDICINES AND
                                RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965)

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 ZVVELINI LAWRENCE MKHIZE, MP
                    MINISTER OF HEALTH

DATE:                  -4.c)

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Government Notice No. 481 of 2020

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