Training Manual Update Logs

Named Patient

Overview

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.

Step 1: Create New Application

1. Log in to the SAHPRA portal.
2. From the Applications Dashboard, click the “Create New Application” button.

Create New Application

Step 2: Select Application Type

1. Select “Section 21 Application” from the available application types.

Select Section 21

2. Click “Next” to proceed.

Step 3: Select Application Subtype and Category

1. Select “Section 21 Application” as the application subtype.

2. Select the appropriate medicine category (e.g., “Category A Medicine”).

Select Medicine Category

3. Click “Next” to proceed.

Step 4: Select Patient Type

1. Select “Named Patient” as the patient type.

Select Named Patient

2. Click “Create” to proceed.

Step 5: Fill in Applicant Details (Section A)

1. Fill in the details of the applicant creating the Section 21 application

Applicant details

Applicant details continued

2. Click “Next” to proceed to Section B.

Step 6: Fill in Importer Information (Section B)

Importer Details

1. Fill in the required Importer and Distributor details

Importer Details

3. Click “Next” to proceed to Section C.

Step 7: Fill in Patient Details (Section C)

Patient Identification

1. Fill in the details of the patient requiring unregistered medicine.

Patient Details

Patient Details continued

2. Click “Next” to proceed to Section D.

Step 8: Fill in Medicine Details (Section D)

1. Fill in all the required information about the unregistered medicine you are applying for.

• For more details on the API manufacturer Information search function click here

Medicine Details

Medicine Details continued

Medicine Details continued

6. Click “Next” to proceed.

Step 9: Upload Additional Documents

1. Upload any additional documents that is relevant to your application

AdditionL Documents

2. Click “Next” to proceed.

Step 10: Review and Submit

1. Review all entered information for accuracy and completeness.

2. Click “Continue To Order” to proceed to payment.

Continue To Order

Step 11: Process Payment

1. Select “EFT” as the payment method.

2. Upload your proof of payment by clicking the upload button and selecting your file.

3. Click “Submit Proof” to submit your payment proof.

Upload Payment Proof

4. You will be returned to the Applications Dashboard.

Tips for Named Patient Applications

• Ensure the patient’s consent form is properly completed and signed.
• Double-check the ICD11 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.