A.101/1965

MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965

SUMMARY

The main objects of this Act are (inter alia) to provide for the registration of medicines and related substances intended for human and animal use, the establishment of the Medicines Control Council and the control of medicines, scheduled substances and medical devices.

SECTIONS OF THE ACT THAT MAY APPLY TO YOU

Section 22A: Control of Medicines and Scheduled Substances

Subject to this section, no person may sell or have in their possession or manufacture any medicine or scheduled substance, unless it is in accordance with the conditions prescribed in this Act.

Compliance Obligations?

The Minister has prescribed the scheduled substances referred to in this section. Note that any Schedule 0 substance may be sold in an open shop. Note the various restrictions on the sale of Schedule 1 substances as set out in section 22A(4). Note further the restrictions that apply to the sale of any Schedule 2, 3, 4, 5 or Schedule 6 substances as set out in section 22A(5) and (6). Note the requirements around Schedule 7 and 8 substances as set out in the remaining sections of section 22A.

Section 22C: Licensing

This section makes provision for issuing licenses to medical practitioners, dentists, practitioners, nurses or other persons registered under the Health Professions Act 56 of 1974 to compound and dispense medicines.

Compliance Obligations?

If compounding and dispensing of medicines takes place, ensure that the relevant persons are properly licensed. A license will only be issued if the applicant has successfully completed a supplementary course determined by SA Pharmacy Council. Further to this, no person may compound or dispense medicine unless they are authorized to do so under the provisions of the Pharmacy Act 53 of 1974, or is a vet or holds a license as referred to above.

Section 33: Acts or Omissions by Manager, Agent or Employee

This section makes provision for the vicarious liability of an employer for the actions or omissions of employees or agents in the circumstances set out in this section.

Compliance Obligations?

Note the exceptions set out in section 33(1). Ensure that all reasonable steps are taken to avoid this situation from arising.

REGULATIONS AND OTHER IMPORTANT INFORMATION
  • HEALTH PROFESSIONS ACT 56 OF 1974
  • MRSA: ANNUAL SINGLE EXIT PRICE ADJUSTMENT OF MEDICINES AND SCHEDULED SUBSTANCES FOR THE YEAR 2024
  • MRSA: APPLICATION FEE: APPLICATION FOR A LICENCE TO COMPOUND OR DISPENSE MEDICINES AS PUBLISHED UNDER GN R.713 IN GG 32358 OF 01 JULY 2009
  • MRSA: EXCLUSION OF SCHEDULE 2, SCHEDULE 3 AND SCHEDULE 4 SUBSTANCES FROM THE OPERATION OF CERTAIN PROVISIONS OF THE ACT AS PROMULGATED UNDER GN 252 IN GG 44322 OF 25 MARCH 2021
  • MRSA: GENERAL REGULATION AS PUBLISHED UNDER GN 859 IN GG 41064 OF 25 AUGUST 2017 AS AMENDED UP TO AND INCLUDING GNR 3343 IN GG 48475 OF 28 APRIL 2023
  • MRSA: REGULATION EXCLUDING COVID-19 VACCINES FROM CERTAIN PROVISIONS OF THE MEDICINES AND RELATED SUBSTANCES ACT PUBLISHED UNDER GNR 1502 IN GG 45487 OF 15 NOVEMBER 2021
  • MRSA: REGULATIONS PROHIBITING CERTAIN ALCOHOL-BASED HAND RUBS FROM THE OPERATION OF SPECIFIED PROVISIONS OF THE MRSA AS PUBLISHED UNDER GNR 756 IN GG 45057 OF 27 AUGUST 2021
  • MRSA: REGULATIONS RELATING TO A TRANSPARENT PRICING SYSTEM FOR MEDICINES AND RELATED SUBSTANCES: DISPENSING FEE FOR PHARMACISTS AS PROMULGATED UNDER GNR 2243 IN GG 46673 OF 06 JULY 2022
  • MRSA: REGULATIONS RELATING TO THE EXCLUSION OF SCHEDULE 0 MEDICINE FROM THE OPERATIONS OF THE MEDICINES AND RELATED SUBSTANCES ACT AS PUBLSIHED UNDER GN 1581 IN 45616 OF 10 DECEMBER 2021
  • MRSA: SCHEUDLE 6 AS PROMULGATED IN GN 5181 UNDER GG 51171 OF 6 SEPTEMBER 2024
  • PHARMACY ACT 53 OF 1974