The Licensing Unit, Licences & Permits
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 of 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 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 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.
This section covers questions about the NDoH Licensing Unit, licences, permits and using the PuLSe system to apply for, manage, and verify licences and permits.
For queries you can email pulse@health.gov.za – ensure that the subject line of your email contains at least the following:
Follow the steps below to apply for a licence or permit;
Advertising your intention to apply for a licence/permit is not necessary.
You can just register on PuLSe and follow the instructions on how to apply for a licence/permit.
Dispensing Licence & Compounding and Dispensing Licence - Private sector only
Yellow Fever Licence - Private sector only
Section 22A (15) Permit
Regulation 31 - Midwife Permit
You can use electronic funds transfer (EFT) into the Department’s ABSA bank account using the account details below;
Bank name: ABSA
Account Holder: National Department of Health
Branch: Vermeulen Street
Branch code: 632005
Account No: 4053643510
Account type: Cheque account
Reference: To be provided to you upon application
The licence / permit application procedure will start once you have uploaded the documents supporting your application. A new application is finalised within 90 days of receipt of all required documentation.
The application for a Section 22A (15) Permit of the Medicines and Related Substances Act (Act 101 of 1965) follows a different procedure.
These permits are issued by the Director-General after consultation with the South African Pharmacy Council (SAPC). On receipt of your online application, a copy of the application will be submitted to the SAPC for consideration with reviews taking place once a quarter. The National Department of Health finalises all applications within 30 days of receiving a recommendation from the SAPC.
For contact details for the National Department of Health Licensing Unit, including their physical address, please see the Contact Us page on this site.
For a list of the providers that have been accredited to provide dispensing courses, please visit www.pharmcouncil.co.za. Please contact the South African Pharmacy Council on 0861 7272 00 or +27 12 319 8500 if you have any questions in this regard.
For more information on where to do a travel medicine course please contact the South African Society of Travel Medicine (SASTM) at www.sastm.org.za.
How can we help you? Please use our Contact Us section.
National Department of Health (NDoH)
www.health.gov.za
Board of Healthcare Funders of Southern Africa (BHF)
www.bhfglobal.com
South African Pharmacy Council (SAPC)
www.pharmcouncil.co.za
The Allied Health Professions Council of South Africa (AHPCSA)
www.ahpcsa.co.za
South African Nursing Council (SANC)
www.sanc.co.za
Health Professional Council of South Africa (HPCSA)
www.hpcsa.co.za
South African Veterinary Council (SAVC)
www.savc.org.za
Should you require any additional information please contact us, or use the Send us email form.
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