Training Manual Update Logs

Multiple Patient

Overview

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.

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 “Multiple Patient” as the patient type.

Select Multiple 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 Group Details (Section C)

Unlike the Named Patient application, the Multiple Patient application requires general diagnosis information for the patient group rather than individual patient details.

Diagnosis Information

7. 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

2. 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 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.