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Pharmacy Act 53 of 1974, Medicines and Related Substances Act 101 of 1965 and Selected Rules & Regulations


Editors:
Juta’s Law Editors | ISBN (Print): 978 1 48513 825 9; (eBook) 978 1 48514 080 1 | Retail price: To be advised.

Designed to assist pharmacists in complying with the law, this updated edition unpacks rules relating to good pharmacy practice, fees and levies, and medicines pricing, among others.

In terms of the Good Pharmacy Practice (GPP) of South Africa, pharmacists are required by law to have the following compulsory legislation available on the premises to comply with the South African Pharmacy Council (SAPC) inspection:

The Pharmacy Act 53 of 1974

  • Regulations and Rules under the Pharmacy Act 53 of 1974

The Medicines and Related Substances Act 101 of 1965

  • Regulations under the Medicines and Related Substances Act 101 of 1965

Rules Relating to Good Pharmacy Practice (GPP)

This book is designed to assist pharmacists to comply with these SAPC requirements as stipulated in the GPP. The 5th edition reflects the law as at 4 November 2022.

UPDATES IN THE 5TH EDITION:

  • Rules Relating to Good Pharmacy Practice Amended (BN 81 in GG 43495 of 3 July 2020)
  • Rules Relating to the Services for which a Pharmacist May Levy a Fee and Guidelines for Levying Such a Fee or Fees Amendment in BN 35 in GG 42337 of 29 March 2019 (NEW)
  • Transparent Pricing System for Medicines and Scheduled Substances:
    • Amended (GN 377 in GG 43145 of 27 March 2020)
    • Amended (GN 679 in GG 43447 of 19 June 2020)
    • Amended (GenN 139 in GG 44333 of 26 March 2021)
  • Medicines Control Council: Schedules –
    • Amended (GN Rs 219 & 220 in GG 43051 of 28 February 2020)
    • Amended (GN R586 in GG 43347 of 22 May 2020)
    • Amended (GN R1375 in GG 44019 of 18 December 2020

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