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Creating a Section 21 Application

Overview

This guide covers the creation of both types of Section 21 application:

• Named Patient applications are used when requesting authorization for an unregistered medicine for a specific, identified patient. These applications require detailed information about both the patient and the requested medicine.
• Multiple Patient applications are used when requesting authorization for an unregistered medicine for a group of patients with the same condition. This application type is appropriate when you anticipate treating multiple patients with the same unregistered medicine.

The steps to create the application are the same for both types up to the point where you select the patient type. Select the applicable patient type under Patient type differences below to see what changes.

Video walkthrough

The video below covers the full process of creating and submitting a new Section 21 application, for both Named Patient and Multiple Patient applications.

Application steps

The written steps below summarise the process shown in the video.

1. Create the application. Log in to the SAHPRA portal. From the Applications Dashboard, click Create New Application.
2. Select the application type. Select Section 21 Application from the available application types and click Next.
3. Select the subtype and category. Select Section 21 Application as the application subtype, then select the appropriate medicine category (e.g. Category A Medicine) and click Next.
4. Select the patient type. Select either Named Patient or Multiple Patient, then click Create.
5. Section A: Applicant Details. Fill in the details of the applicant creating the Section 21 application, then click Next.
6. Section B: Importer/Distributor. Fill in the required Importer and Distributor details, then click Next.
7. Section C: Patient Details. Complete this section according to the patient type you selected — see the type-specific notes below. Click Next.
8. Section D: Medicine Details. Fill in all the required information about the unregistered medicine you are applying for, then click Next.
   • For more details on the API Manufacturer Information search function, click here.
9. Upload additional documents. Upload any additional documents relevant to your application, then click Next.
10. Review and submit. Review all entered information for accuracy and completeness, then click Continue To Order to proceed to payment.
11. Process payment. Select EFT as the payment method, upload your proof of payment, and click Submit Proof. You will be returned to the Applications Dashboard.

Key Information Required

Select to view every field in Sections A to D, and which are required

Section A: Applicant

Note: For this section all fields are required.

• Title (Dropdown) - Required
• Full Name and Initials (Text input) - Required
• Surname (Text input) - Required
• Health Professions Council (South Africa) Registration Number (Text input) - Required
• HPCSA registration certificate (File upload) - Required
• Registered Qualifications (Text input) - Required
• Registered specialty under which you are currently practising and treating the patient mentioned in section C below (Text Field) - Required
• Practice Number (BHF No) (Text input) - Required
• Cellular Phone Number (Text input) - Required
• Site Address (Searchable input) - 1 Required
  • Add Address (Optional additional address)
• Contact Person(s) to answer queries/outcome about the unregistered medicine - 1 Required
  • Cellular Phone Number (Text input)
  • E-mail address (Text input)
  • Add Contact (Optional additional contact)

Section B: Importer/Distributor

Note: For this section the dropdown values can be used or text values can be entered but the fields for Licensed Importer are required for a valid outcome report.

• Select Licensed Importer (Dropdown with searchable list) - Required
  • Status (read-only field)
  • SAHPRA License Number (Text input or auto-filled)
  • SMF Number (Text input or auto-filled)
  • Physical Site Address (Searchable field)
• Select Licensed Distributor - Not Required
  • Select Name (Dropdown with searchable list)
  • Status (Auto-filled or read-only field)
  • SAHPRA License Number (Text input or auto-filled)
  • SMF Number (Text input or auto-filled)
  • Physical Site Address (Searchable input)

Section C: Patient Details

Select your application type to see the fields that apply.

Named Patient

• Title (Dropdown) - Required
• First Name (Text input) - Required
• Surname (Text input) - Required
• Age (Text input or number field) - Required
• Gender (Dropdown) - Required
• Weight (Kg) (Text input) - Required
• Height (Cm) (Text input) - Required
• Residential Address (Text input) - Required
• Occupation (Text input) - Required
• Telephone Number (Office Hours) (Text input) - Required
• Cellular Number (Text input) - Required
• Positive Proof of Identification (File upload) - Non Required
• Diagnosis (ICD-11 Code) (Searchable dropdown)
• Severity (Dropdown) - Required
• Staging (Dropdown) - Required
• Prognosis (Dropdown) - Required
• Treatment Regimen (Dropdown) - Required
• Details of Current Treatment Regimen (Text input) - Required
• Add Diagnosis and treatment (Optional button to add additional entries)
• Concomitant Disease/s - Required (Brief description including severity, staging, prognosis where applicable. Indicate the current standard treatment regimen for the concomitant disease.)
• Diagnosis (ICD-11 Code) (Searchable dropdown) - Required
• Severity (Dropdown) - Required
• Staging (Dropdown) - Required
• Prognosis (Dropdown)- Required
• Treatment Regimen (Dropdown) - Required
• Details of Current Treatment Regimen (Text input) - Required
• Informed Consent of Patient (File upload) - Required

Multiple Patient

Note: Only the diagnosis of the patient group applies to a Multi-Patient application. The individual patient identification fields listed under Named Patient are not applicable.

• Diagnosis (ICD-11 Code) (Searchable dropdown)
• Severity (Dropdown) - Required
• Staging (Dropdown) - Required
• Prognosis (Dropdown) - Required
• Treatment Regimen (Dropdown) - Required
• Details of Current Treatment Regimen (Text input) - Required

Section D: Medicine Details

Subsections 1, 2, 4 and 5 below apply to both application types. Only the fields under 3. Medicine Formulation, Quantity, Prescription, and Treatment Plan Details differ, so select your application type there.

1. API (Active Pharmaceutical Ingredient) Details search

• INN Name (Auto-filled or editable if manual override enabled after search) - Required
• Manufacturer (Auto-filled or editable if manual override enabled after search) - Not Required
• API Manufacturer Number Type (Auto-filled or editable if manual override enabled after search.) - Not Required
• Number (Auto-filled or editable if manual override enabled after search) - Not Required

2. Final Product Manufacturer Information

• Manufacturer Search by Name (Search field) - Required
• SMF Number (Text input) - Not Required
• GMP Information
  • Approval Number (Text input) - Not Required
  • Approval Date (Date picker) - Not Required
  • Name of Regulatory Body that Issued Certificate (Text input) - Not Required
  • Upload GMP Certificate (File upload) - Not Required

3. Medicine Formulation, Quantity, Prescription, and Treatment Plan Details

Select your application type to see the fields that apply.

Named Patient

• Proposed Proprietary Name (Text input) - Required
• Strength (Numeric input) - Required
• Unit of Measurement (Dropdown e.g., mg, ml, IU) - Required
• Route of Administration (Dropdown e.g., Oral, IV) - Required
• Dosage Form (Dropdown e.g., Tablet, Injection) - Required
• Pack Size (Numeric input) - Required
• Intended Patient Pack Selling Price (ZAR) (Currency input) - Required
• Upload Medical Prescription (File upload) - Required
• Upload Professional Information (e.g. Package Insert, SmPC, Investigator’s Brochure) (File upload) - Required
• Dosage Unit (e.g., 1 tablet) (Text input) - Required
• Dosage Interval (e.g., Every 8 hours) (Text input) - Required
• Duration of Total Treatment (e.g., 7 days) (Text input) - Required

Multiple Patient

Note: Upload Medical Prescription is not applicable to a Multi-Patient application.

• Proposed Proprietary Name (Text input) - Required
• Strength (Numeric input) - Required
• Unit of Measurement (Dropdown e.g., mg, ml, IU) - Required
• Route of Administration (Dropdown e.g., Oral, IV) - Required
• Dosage Form (Dropdown e.g., Tablet, Injection) - Required
• Pack Size (Numeric input) - Required
• Intended Patient Pack Selling Price (ZAR) (Currency input) - Required
• Number of Patients (Numeric input) - Required
• Patient Treatment History or evidence to justify amount of patients (File upload) - Required
• Upload Professional Information (e.g. Package Insert, SmPC, Investigator’s Brochure) (File upload) - Required
• Dosage Unit (e.g., 1 tablet) (Text input) - Required
• Dosage Interval (e.g., Every 8 hours) (Text input) - Required
• Duration of Total Treatment (e.g., 7 days) (Text input) - Required

4. Registration Status in Other Countries

• Registered / Unregistered (Radio buttons) - Not Required
• Select Country (Dropdown) - Not Required
• In which country is the Patient Pack Registered (Text input) - Not Required
• NRA Name (Text input) - Not Required
• Name of National Regulatory Authority (Text input) - Not Required

5. SAHPRA-Registered Medicines for the Unmet Medical Need

• Search SAHPRA Medicines Registry (Search field) - Required
• Reason for Not Using a SAHPRA-Registered Medicine or Treatment Regimen (Text area) - Required
• Upload Supporting Document for Reason (File upload) - Not Required

Supporting Documents

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

Upload Requirements

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

Outcome Letter

• Once your application has been rejected or approved the Signed Outcome Letter will reside in the Application Documents section of the application. Simply find the application on your Application Manager and click on the Overview option under the Actions available on the right-hand side of the application.

Patient type differences

Select your application type below.

Named Patient

In Section C: Patient Details, you fill in the details of the individual patient requiring the unregistered medicine. All patient identification, diagnosis, and treatment fields apply.

Tips for Named Patient Applications

• Ensure the patient’s consent form is properly completed and signed.
• Double-check the ICD-11 code for accuracy.
• Provide detailed clinical information to support the need for the unregistered medicine.
• Clearly explain why registered alternatives cannot be used.
• Include all required supporting documentation to avoid delays.
• Follow up on your application if you don’t receive a response within 48 hours, as Named Patient applications are typically processed urgently.

Multiple Patient

Unlike the Named Patient application, the Multiple Patient application requires general diagnosis information for the patient group rather than individual patient details. Only the Diagnosis is applicable in Section C.

You must also indicate the Amount of Patients to be treated, along with an upload providing justification for the indicated number of patients.

Tips for Multiple Patient Applications

• Provide accurate estimates of the number of patients to be treated.
• Include comprehensive clinical information to support the need for the unregistered medicine for the patient group.
• Clearly explain why registered alternatives cannot be used for this patient population.
• Keep detailed records of which patients receive the medicine under this authorization.
• Be aware that Multiple Patient applications may take longer to process than Named Patient applications.
• Consider applying for a Named Patient application if urgent treatment is needed for a specific patient while waiting for the Multiple Patient application to be approved.

Next Steps

• Once your application has been approved, you will need to submit a Patient Outcome Report.
• To extend an existing authorization, refer to Reauthorisation.