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Introduction

The licensing and registration of complementary medicines in South Africa has been a popular point of discussion throughout the last two years. With the licensing deadline around the corner, we have been getting numerous requests relating to the licensing and registration of complementary medicine. The aim of this article is to discuss and summarise the process to become a licensed facility and how to register your medicinal product with SAHPRA.

Regulatory Requirements

Effective as of the 15th of November 2013, the then Medicines Control Council, currently SAHPRA, by virtue of powers vested in it by section 14(2) of the Act, by resolution approved by the Minister of Health, determined that complementary medicines falling in Category D and in the different pharmacological classifications are subjected to registration as per the provisions of the Act. The SAHPRA has taken steps to ensure that the above-mentioned process has been implemented over the past 8 years, in doing so they have requested that all manufactures, importers, exporters and wholesalers of complementary medicines are licensed as per section 22C(1)(b) of the medicines act and that all category D medicines be subjected to registration (“call-up notices”) in terms of section 14 of the Medicines and Related Substance Act, 1965 (Act 101 of 1965). The licensing and registration process must be preceded by obtaining a Pharmacy Premises Licence through the National Department of Health (NDOH) and confirmation of compliance with GPP from South African Pharmacy Council (SAPC).

What classifies a medicine as Category D?

The Complementary Medicines (Category D) category was established on 15th Nov 2013, the minister of health published amendments to the general regulations made in terms of the medicines and related substances act, 1965 (Act 101 of 1965). The medicines that fall under this category originate from the six major disciplines recognized by the SAHPRA, namely:

  • Aromatherapy
  • Ayurveda
  • Homeopathy
  • Traditional Chinese Medicine
  • Unani Medicine (Unani-Tibb)
  • Western Herbal Medicine

The category of Complementary Medicines was broadened to establish two sub-categories of Category D (Complementary medicines), namely:

  • Traditional disciplines that are not indigenous to South Africa (Discipline-Specific Medicines)
  • Modern supplement-type of medicines (Health supplements)

Licensing of Manufacturers, Importers, Exporters, and Wholesalers or Distributors

As per the provisions of section 22C(1)(b) of the Medicines Act, all manufacturers, wholesalers or distributors of medicines or Scheduled substances must be licensed, as the case may be, to manufacture, import, export, or act as a wholesaler of or distribute medicines, inclusive of Category D medicines. This means that compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) or Good Wholesaling Practices (GWP), as may be applicable, will be required. The licenses categories are stated on the SAHPRA Complementary medicines portal as:

  • Type DL01 – Licence to manufacture, import or export Complementary Medicines (Category D)

[manufacturers only]

  • Type DL02 – Licence to import or export Complementary Medicines (Category D)

[holders of certificate of registration]

  • Type DL03 – Licence to act as a wholesaler of or distribute Complementary Medicines (Category D)

[wholesalers or distributors]

The application portal is available at www.sahpracm.org.za and includes new applications, renewal applications as well as applications for amendments to existing licences.

Inspection and Issuing of Licences

The Authority may rely upon relevant/appropriate GMP inspection reports by PIC/S members for the issuing of the licence but will consider conducting individual inspections as merited by the risk or other reasons associated with products manufactured or managed by any international site.

Licences will be issued to successful applicants based on the SAHPRA’s acceptance of the applicant’s attestation of compliance with minimum requirements at the time of application and the payment of the required licence application, and desktop evaluation fees.

All licences issued will be valid for a period of five (5) years, during which the holder of the licence must be inspected, at least once.

Key Quality Requirements

When applying for your relevant GMP, GDP or GWP based license ensure that you consider and accurately adhere to the following key quality aspects:

  • Hiring a Responsible Pharmacist and other key personnel.
  • Create and Maintain a Site Master File
  • Implement a robust and accurate Quality Management System (QMS)
  • Create a Quality Manual
  • Create a Quality assurance report, detailing the following:
    1. The Quality assurance product release process
    2. The Product recall procedure
    3. Finished product specifications and testing
    4. Product sterilisation (if applicable)
    5. Determination of shelf life (expiry date)
    6. List of SOPs (titles and numbers related to Quality management system)
  • Create and submit a 3D Product list
  • The control of materials should be described in your SOP’s
  • The control of active pharmaceutical ingredient should be described in your SOP’s
  • Identify critical process parameters
  • Identify critical quality attributes
  • Process Validation: Provide process validation and / or evaluation studies (based on historical data).
  • QC testing- analytical procedures and validation of procedures
  • Batch analysis: Batch traceability and release
  • Packaging process validation
  • Labelling
  • Patient Information Leaflets
  • Professional Information

Medicines Registration Process

All applications for registration that have already been submitted will continue to be processed and will be finalised as soon as possible. For those applicants with products not associated with valid licences this may occur only once the relevant licence in terms of section 22C(1)(b) of the Medicines Act has been issued.

The Authority will provide online mechanisms for the submission of applications for registration of category D Medicines, which will continue to make use of the CTD, the electronic format will provide guidance on the requirements of category D medicines and their risk profile.

Summary of the Critical Steps

NDOH and SAPC

  1. The process of licensing should be initiated by an applicant applying for a Pharmacy Premises Licence to the National Department of Health (NDOH). This may be submitted via the South African Pharmacy Council (SAPC) website.
  2. The NDOH reviews and verifies the completeness of the application.
  3. The application is forwarded for further review to the relevant NDOH committees and SAPC.
  4. The NDOH committees will provide a recommendation concerning their review.
  5. The SAPC will undertake a desktop review of Good Pharmacy Practice (GPP) and may issue a recommendation of apparent GPP compliance based on the desktop review undertaken to the applicant and will notify the NDOH of such.
  6. The applicant, in possession of the proof of the NDOH application made in step 1 (such as a screenshot of the application case number confirmation) as well as the confirmation of compliance with GPP from SAPC may proceed to point 7 and utilise these documents for the initiation of an application for the relevant Category D licence. SAHPRA
  7. An applicant may, once the documents in step 6 are available, apply to the South African Health Products Regulatory Authority (SAHPRA) for the appropriate Category D medicine licence via the online SAHPRA CM complementary medicines portal available at www.sahpracm.org.za. An applicant must first be registered as a SAHPRA CM website user and then log in to access the applications by navigating to “Applications” – “Licensing” – “APPLY” – “1. New Applications” which provide options for new licences including:
    • Type DL01
    • Type DL02
    • Type DL03
  8. SAHPRA will undertake a desktop review of the application submitted in step 7 concerning apparent compliance with Good Manufacturing Practice (GMP), Good Distribution Practices (GDP) or Good Wholesaling Practices (GWP), as may be applicable, based on the attestation and documents provided. SAHPRA will also verify that the list of products supplied in the section 3D product list includes only bona fide Category D medicines.
  9. Following successful review of the application, including review of any replies from the applicant, SAHPRA may then recommend the issuing of a licence in terms of section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) to the applicant who, in turn, may provide this to the NDOH.
  10. SAHPRA notifies the NDOH of the issuing of the section 22C(1)(b) licence specific to Category D medicines to the applicant.
  11. The NDOH may, following satisfaction of all application criteria, issue a premises licence to the applicant.
  12. The applicant may proceed to record the NDOH licence with the SAPC online in the manner and timeframe prescribed. The SAPC issues the certificate of recording for the pharmacy and pharmacy owner, and a certificate of registration for the responsible pharmacist.
  13. Within five (5) years from the date of issue, the holder of the licence must be inspected by SAHPRA against the applicable standards. In the case of GPP certificates issued without an inspection by the SAPC (desktop review only) then a joint inspection by SAHPRA and SAPC must take place.
  14. The NDOH may be notified of the SAPC inspection outcome.
  15. Following a successful SAHPRA inspection, an application for the renewal of the Category D licence issued in terms of section 22C(1)(b) may take place including the outcomes of steps 9, 11, 12, 13.

Summary of Timelines

Guidelines

For further and more specific information, visit the SAHPRA website (See in the link below) and download the category D medicines guidelines.

https://sahpracm.org.za/catd/cm-home/guidelines_docs/

The guidelines include the following:

7.01: DISCIPLINE-SPECIFIC SAFETY AND EFFICACY

7.02: ROADMAP AND TRANSITIONAL PROCESS FOR THE REGULATION OF COMPLEMENTARY MEDICINES

7.03: USE OF THE ZA-CTD FORMAT IN THE PREPARATION OF A REGISTRATION APPLICATION

7.04: HEALTH SUPPLEMENTS: SAFETY AND EFFICACY

7.05: REGISTRATION APPLICATION ZA-CTD – QUALITY

7.06: GUIDANCE ON SPECIFIED SUBSTANCES

Referneces: https://sahpracm.org.za/catd/cm-home/guidelines_docs/

Cannabidiol (CBD) Registration

Should CBD, under 600mg per unit (20mg daily) be registered as a Complementary Medicine?

The answer is YES.

CBD will form part of the Specified Substances registration process.

SAHPRA published the latest guideline 7.06 (Specified substances) for implementation in Jan 2022, the guideline is now available for comment with the deadline being 30 April 2022

In assessing the safety, efficacy and quality of Cannabidiol (CBD) the attached Annexure 4 (See link below) has been developed to guide the use of the substances listed therein when used in Complementary Medicines as Health Supplements.

Annexure 4 link: https://www.sahpra.org.za/wp-content/uploads/2022/02/7.06_CMs_Specified_Substances_Jan22_v3_2.pdf