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Overview

What are Section 21 Applications?

Section 21 of the Medicines and Related Substances Act allows for the use of unregistered medicines in South Africa under specific circumstances. The Section 21 application process enables healthcare professionals to request authorization from SAHPRA to access and use medicines that are not registered in South Africa

Types of Section 21 Applications

There are two main types of Section 21 applications:

  1. Named Patient Applications: For individual patients requiring unregistered medicine
  2. Multiple Patient Applications: For groups of patients requiring the same unregistered medicine

Section 21 Application Types

Application Process Overview

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flowchart TD
    A[Start Application] --> B[Select Section 21 Application]
    B --> C[Select Medicine Category]
    C --> D[Choose Patient Type]
    D --> E{Patient Type?}
    E -->|Named Patient| F[Complete Named Patient Form]
    E -->|Multiple Patient| G[Complete Multiple Patient Form]
    F --> H[Fill Applicant Details]
    G --> H
    H --> I[Fill Importer Information]
    I --> J[Fill Medicine Details]
    J --> K[Process Payment]
    K --> L[Application Submitted]

Key Information Required

Regardless of the application type, you will need to provide:

1. Applicant Information

  • Professional registration details
  • Qualification and specialty
  • Contact information

2. Importer Information

  • Licensed importer details
  • SAHPRA license number
  • SMF number
  • Importer address

3. Patient Information

For Named Patient applications: - Patient demographics - Diagnosis details (ICD10 codes) - Clinical information

For Multiple Patient applications: - General diagnosis information - Estimated number of patients

4. Medicine Information

  • API manufacturer details
  • Final product manufacturer information
  • GMP information
  • Drug details (name, strength, dosage)
  • Registration status in other countries

5. Supporting Documentation

Below is the list of possible additional documents required:

  • Manufacturing license
  • GMP Certificate
  • Approved or proposed Product package insert
  • Motivation letter
  • Linked to dosing evidence from peer-reviewed articles
  • Peer reviewed articles for the use in the stated diagnosis, copy of publication in peer reviewed scientific journal
  • MC & S reports
  • Out-of-stock letter
  • Discontinuation letter
  • Cultivation Licence
  • Certificate of Analysis (COA), Professional Information
  • Patient information leaflet
  • Target Product Profile
  • Investigational Medicinal Product Brochure
  • Clinical Study Reports
  • Clinical Development Plan
  • Meta-analyses
  • Risk Management Plan
  • Public assessment reports
  • Country-specific documents
  • Access Program pre-approval form

6. Document Upload Requirement

  • Please rename any uploaded files to contain the application number for the applicaiton you are currently completing
  • eg. “GPM_Certificate_S2100000010.pdf”

Fees and Payment

  • Note: The application fee will be waived for applicants who reside in a Public Healthcare Institution registerd as such on the portal.
  • Applicants must first complete the whole application of which at the end an order number will be generated. This generated order number must be used as the beneficiary reference number on the proof of payment.
  • To initiate a refund, refer to the SAHPRA Payment Guideline

Section 21 applications require payment of the prescribed fee. The payment process is similar to other SAHPRA applications:

  1. Submit the application
  2. View the order details
  3. Make payment via EFT
  4. Upload proof of payment
  5. Wait for payment verification

Processing Timeframes

  • The processing for all applicaitons will take up to three working days (Excluding the timeframe in which applications are Queried)
  • Applications are deemed submitted once the payment has been approved by SAHPRA

Next Steps