About Us

The Licensing Unit

The Licensing Unit is a functional area within the Affordable Medicines Directorate of the National Department of Health. The responsibilities of this sub-directorate include processing applications for permits and licences issued in terms of the Medicines and Related Substances Act (the Medicines Act), licences to administer Yellow Fever vaccines in terms of the International Health Regulations Act 28 of 1974, as well as the designation of health rendering organisations in terms of the Nursing Act 33 of 2005.

Licences and Permits

Licences provided for in Section 22C(1)(a) of the Medicines Act are issued to medical practitioners, dentists, nurses, and other health professionals registered with the Health Professions Council of South Africa (HPCSA) and the Allied Health Professions Council of South Africa (AHPCSA) to allow licence holders to dispense, or compound and dispense medicines, on prescribed conditions. Applicants must have completed a course in dispensing medicines which has been accredited by the South African Pharmacy Council (SAPC) prior to applying for a licence. Approved courses and training providers are published on the SAPC website www.sapc.za.org.

Licences issued in terms of Regulations made under the International Health Regulations Act 28 of 1974 are issued to medical practitioners, nurses and pharmacists for the purpose of administering the yellow fever vaccine at specific vaccinating centres.

Permits issued in terms of Section 22A(15) of the Medicines Act allow the permit holders to acquire, possess, use and supply medicines for conditions specified in an annexed list and in line with the Standard Treatment Guidelines and Essential Medicines List (STG EML). The permits issued in terms of Section 22A(15) of the Medicines Act enable permit holders to acquire, possess, use and supply medicines for the provision of immunisation services, family planning services, midwifery services and for the treatment of minor ailments. Permits issued in terms of Regulation 31 of the Medicines Act are issued to midwives and accoucheurs registered with the South African Nursing Council (SANC) to allow permit holders to purchase, acquire or keep for administration to patients Schedule 5 or 6 medicines for intra-partum care. Licences and permits are subject to conditions as determined by the Director-General.

The Unit also administers the licensing of pharmacy premises as provided for in terms of the Pharmacy Act 53 of 1974. This is done in collaboration with the South African Pharmacy Council and the South African Health Products Regulatory Authority (SAHPRA). For additional details in this regard please visit the SAPC (www.sapc.za.org) and SAHPRA (www.sahpra.org.za) websites.

Who may apply for Licences or Permits?



DENTISTS


PHARMACISTS


HOMEOPATHS


MEDICAL PRACTITIONERS


NURSES

TRADITIONAL CHINESE MEDICINE PRACTITIONERS


PHYSIOTHERAPISTS