Inspectorate, Pharma Licencing, And Regulatory Compliance


Purpose and Operations


The main purpose of this programme is to ensure public access to health products that comply with the quality standards through inspections.


Inspections are conducted at active pharmaceutical ingredient (API) and finished product (FP) manufacturers, wholesalers, laboratories and clinical trial sites, located both locally and internationally.


Relevant Legislation


The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as amended The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) was amended by the Amendment Act, 2008 (Act No.72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015), and enacted in May 2017. In terms of the Medicines Act, the objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, medical devices, radiation control, clinical trials and related matters in the public interest, in the following ways:


  • Ensure that compliance with existing legislation is promoted and achieved through a process of active inspection and investigation; and
  • Liaise with any other regulatory authority or institution and may require the necessary information from, exchange information with and receive information from any such authority or institution in respect of
    • matters of common interest; or
    • a specific investigation; and
  • Enter into agreements to co-operate with any regulatory authority to achieve the objects of the Medicines Act.


Reliance and mutual recognition


The Inspectorate’s operations are aided and assisted by the principles of reliance on and cooperation with other organizations, such as X link PIC/S, WHO, and collaboration with X link Zazibona, by mutual recognition of work performed.


1. PIC/S (Pharmaceutical inspection co-operation scheme)


PIC / PIC/S (Refer


PIC (Pharmaceutical Inspection Convention) & PIC/S operate in parallel – jointly referred to as “PIC/S”. South Africa became a member of PIC/S on 1 July 2007 and became the 31 st member of PIC/S and the first member from Africa. PIC/S supports work-sharing in the process of reliance on inspections conducted by other countries in the PICS group. The PIC/S’ mission is to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. This mission is achieved by facilitating co-operation and networking for competent authorities and international organisations, through:


  • Harmonization of GMP/GDP requirements, through development and promotion of harmonised GMP/GDP standards and guidance documents
  • Training competent authorities, in particular Inspectors
  • Assessing (and reassessing) GMP Inspectorates
  • Facilitating the co-operation and networking of competent authorities and international organisations (mutual recognition of inspections)


2. World Health Organization (WHO)


The primary role of the WHO’s is to direct international health within the United Nations’ system and to lead partners in global health responses. This role is evident in the different regulatory strengthening projects and programmes driven by the WHO, also in Africa, such as the SADC Medicines Regulatory Harmonization Project. (Go here:


3. Zazibona


Zaniboni is a collaborative initiative involving 14 Southern African Development Community (SADC) countries. Some of the actively participating countries include Zambia, Zimbabwe, Botswana, Namibia and South Africa. They participate in joint dossier assessment (for registration purposes), training programmes and information sharing so that products can be approved and registered via a collaborative procedure. There is a mutual agreement amongst countries. Applicants give consent for sharing information concerning products to be assessed.


When a product has been approved by Zazibona, the individual countries, for instance, South Africa, can use this decision on a country level to determine the GMP compliance status of the relevant company and subsequently, to register/ not register such a product in the country. Applicants (new dossier registrations) who want to participate in the Zazibona review process should have applied for registration of a medicine in at least two of the participating countries.


The applicant should submit an expression of interest to any of the countries to which the application has been made, to be included in the Zazibona review process. (Go here:


4. Benchmarking of Good Practices


(Refer: Global Competency Framework For Regulators Draft Version 1.2 4 (November 2018))


In support of regulatory system strengthening and capacity building at National Regularity Authorities (NRA), the WHO has initiated a project to establish a global competency framework for regulators. In short, this program is described as follows: “WHO is working with partners to develop a global competency framework and global curricula to support training and professional development of regulatory staff”.


South Africa is part of the pilot implementation of the Global Competency Framework, through various SADC validation workshops for self-assessment of assessors and regulators.


Guidelines below:

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-INSP-06Guideline for Fee determination and Payment of GxP and Product related Inspection14/09/20222pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-05Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report21/09/20222pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-04Guideline for preparation of site master file14/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler07/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-01Guideline for Post Importation Testing15/09/20225pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-02Guideline for Good Manufacturing Practice18/09/20228, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing


How to apply for a Application for a GMP and CPP certificate

Find out more


Legislative Mandate: Section 22C(1)(b) of MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965 as amended and Regulation 23.


Purpose and Operations

To issue to a manufacturer, wholesaler or distributor of a medicine or Scheduled substance, a licence to manufacture, import, export,  act as a wholesaler of or distribute, as the case may be, such medicine, Scheduled substance, upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine.


Licence application process

Submission for the following licence applications only:

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-01AForm for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-05AForm for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes, 10/08/20221, , , docxDownloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance


Guidelines below:

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis10/11/20223, , pdfDownloadguidelinecannabis licencing regulatory-compliance
SAHPGL-LIC-03Guideline on How to Amend a Current Licence22/06/20221pdfDownloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler22/06/20222pdfDownloadguidelinelicencing
SAHPGL-LIC-01Licence to Manufacture, Import or Export09/06/20223pdfDownloadguidelinelicencing
SAHPGL-INSP-04Guideline for preparation of site master file14/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler07/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-02Guideline for Good Manufacturing Practice18/09/20228, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing


Fees below:


Applicant to confirm submission of the following documents prior to accessing the email:


Completed application forms with the following supporting documents:

  1. Licence application cover Letter
  2. Proof of payment with the correct reference as per Annexure A – SAHPRA Fee Categorisation Guideline
  3. Latest Inspection resolution if applicable
  4. Existing Licence being renewed/amended if applicable
  5. CIPC/CIPRO/DTI CERTIFICATES OR DOCUMENTS proving ownership of the business
  10. Copy of POP of the licence annual retention fee for all preceding years if licence is older than a year.
  11. Product List with POP of annual retention fee for each product since the product was registered.

Applicants to submit a zipped file.


Purpose and Operations


The Regulatory Compliance unit of the South African Health Products Regulatory Authority (SAHPRA) is responsible for the enforcing and monitoring compliance of all health products, personnel and the facilities under which those products are handled with the provisions of the Medicines and Related Substances Act 101 of 1965 (Medicines Act) and other Health Acts. The scope includes verifying that human and veterinary medicines and medicines and medical devices and their facilities comply with registration and licensing requirements.


The unit responsibilities include:


1. Monitoring and control of border posts for imports and exports of health products
2. Prevention and monitoring of unregistered health products, Counterfeit (Substandard and
Falsified medical products)
3. Monitor and eradicate emerging illegal retail outlet selling health products
4. Monitor and stop the illicit manufacturing facilities
5. Ensure that unregistered health products are removed from the public
6. Join and actively participate in relevant stakeholder forums including those combating
pharmaceutical crime networks
7. Responsible for all matters relating to Pharmaceutical crime
8. Public Awareness and education on medicines and other health related products

9. Post-marketing surveillance and are as follows:

  • Monitoring that advertising of health products complies with registration conditions
  • Monitoring that licensed health facilities complies with practice requirements
  • Monitor online sale and illicit sale of health products including via social media platforms
  • Prevent and stop healthcare professionals who practice irrational prescribing and dispensing
  • Conduct pharmacovigilance inspections and attend to drug recalls
  • Investigates and attend to complaints regarding contravention of the Medicines Act
  • Conduct training on health products to relevant health


10. Control of Narcotic and Psychotropic Substances

  • Issuing of import and export permits for narcotics and psychotropic substances
  • Issuing of permits for research and/ possession
  • Liaise with the International Narcotics Control Board on import and export of products


11. Cannabis for medicinal purpose and hemp research

  • Licensing of medicinal cannabis: cultivation, manufacturing and distribution
  • Medicinal cannabis related enquiries
  • Issuing of hemp permits for research


12. Section 36 exclusions applications
13. Authorisation for possession of a medicine/s or health product/s in the Republic



View forms



View guidelines


Importation of Medical Products – Border Control

View page


Rapid Alert Systems

View page


Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Cannabis Pre Licence Application Status Letter19/02/20211pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
Process Flow of Importation of Medical Products Published17/07/20231, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices regulatory-compliance
Retention Fee Notification – 9 June 202224/06/20221, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
Communication to Industry – Applications for GMP and CPP Certificates30/06/20221pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines24/03/20221, pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices
SAHPRA survey to determine company turnover31/03/20211, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices licencing



Contact details:


The following telephone numbers can be used to contact the Regulatory Compliance, Inspectorate, and Licensing units


Senior Manager: Inspectorate and Regulatory Compliance

Deon Poovan

Tel: 012 501 0419
Cell: 065 683 9783

Inspectorate Manager

Samu Motshitela

Tel: 012 015 5465

Pharma Licensing Manager

Jerry Molokwane

Tel: 012 501 0359
Cell: 076 422 4934

Dedicated Email Address for Licence Application for Pharmaceutical/GMP/Medicine  ONLY; of Manufacturers, Importers, Exporters and Wholesalers. Any other application will be automatically deleted;


Site Master File dedicated email address for submission of site master files and queries ( for pharmaceutical facilities only and NOT for Medical Device Establishments):


Pharma Licensing Support

Ms Dikeledi Yvonne Motepe

Tel: 012 501 0360
Email & Microsoft Teams call:

Regulatory Compliance Manager

Mokgadi Daphney Fafudi

Tel: 012 015 5434
Cell: 066 301 1878


Import And Export Permit Applications

Dedicated email address for import and export permit applications:


Port Release






Product-related quality complaints and recalls

Mokgadi Daphney Fafudi

Tel: 012 015 5434
Cell: 066 301 1878


Section 36 exemptions

Mokgadi Daphney Fafudi

Tel: 012 015 5434
Cell: 066 301 1878

Cannabis cultivation licence applications and any other cannabis related matters

Ramarumo Chepape

Tel: 012 015 5459
Cell: 082 492 4955

Daphney Mokgadi Fafudi

Tel: 012 015 5434
Cell: 066 301 1878