Contract Management Unit (CMU)

In the medicine value chain, contract management follows the award of a contract. Contract Management Unit (CMU) is responsible to ensure that all parties including the demanders and suppliers fully understand their obligations and responsibilities as stated on the General Conditions of Contract (GCC) and Special Requirements and Conditions of Contract (SRCC).

There are many factors that challenge supply chain processes and ultimately affect medicine availability and accessibility. These supply challenges prompt CMU to embark on interventions to manage stock outs in the short-term, some of these interventions are listed below:

  • Investigation of medicine availability from all registered manufacturers (non-contracted) and obtaining quotations to address the shortfall in supply. Non-contracted manufacturers do not produce high volumes used in the public sector and are therefore only able to provide limited quantities.
  • Working with manufacturing suppliers and provinces to promote rational use of the available stock during the period of supply shortage where there are no therapeutic alternatives.
  • Obtaining authorisation from South African Health Products Regulatory Authority (SAHPRA) in terms of Section 21 of the Medicines and Related Substances Act to source stock from other countries in the event that there is insufficient stock in South Africa, to address shortages.

The management of the bulk procured Section 21 medicines in the public sector is undertaken by the Affordable Medicines Directorate at National Department of Health (NDoH). Section 21 medicines are unregistered medicines in South Africa and these medicines are sourced through SAHPRA. NDoH applies for bulk Section 21 authorisations from SAHPRA. SAHPRA may provide authority for the bulk sale and use of the unregistered medicine in accordance with the provisions of the Medicines and Related Substances Act 101 of 1965. The use of the unregistered medicine is considered only for emergency situations where the registered essential medicine is not available for an unmet medical need and there is no therapeutic alternative. Section 21 medicines should only be limited to essential medicines.

Section 21 AuthorisationsValid until
Section 21 Authorisation re Streptokinase 1.5MU INJ 19 March 2025
Section 21 Authorisation re Haloperidol 5mg INJ 1mL INJ16 March 2025
Section 21 Authorisation re Protamine 10mg INJ 5ml5 February 2025
Section 21 Authorisation for Bivalent Oral Poliomyelitis Vaccine 20-Dose Vial15 January 2025
Section 21 Authorisation re Equine Anti-Rabies Immunoglobulin 1500IU INJ 5mL4 January 2025
Section 21 Extension Authorisation re Glyceryl Trinitrate 1mg INJ4 January 2025
Section 21 Extension Authorisation re Phenobarbitone 200mg INJ 3 January 2025
Section 21 Extension Authorisation for Benzyl Penicillin 1MU INJ22 November 2024
Section 21 Extension Authorisation for Benzyl Penicillin 5MU INJ12 October 2024
Section 21 Extension Authorisation for Aciclovir Eye Ointment 5g Tube30 September 2024
Contact Us: nhi.info@health.gov.za