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Submitting six-monthly reports for Authorised Prescribers

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This user guide is for medical practitioners who hold an Authorised Prescriber (AP) authorisation. 

If you are an Authorised Prescriber, you must submit a report every 6 months for each AP authorisation you hold. This is a condition of authorisation. 

This guide explains:

Reporting periods

There are 2 reporting periods each year.

1 January to 30 June

  • Reporting opens 1 July.
  • Reports must be submitted by 31 July.

1 July to 31 December 

  • Reporting opens 1 January.
  • Reports must be submitted by 31 January.

Your reports must be submitted by the due date for each reporting period to meet your legislated AP reporting obligations under section 47B of the Therapeutic Goods Regulations (1990).

We will send a reminder to the email address recorded in your system account when reporting opens.

How to submit your report

Reporting is submitted through the Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (the system).

Step 1: Access your account

Log into your account in the Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System.

For help resetting your password see: Authorised Prescriber: online system.

Figure 1: AP Reports dashboard

screenshot of authorised prescriber reports table from SAS and AP online system

Step 3: Open the reporting period

Find the relevant reporting period.  In the Actions column, select the arrow icon, then select Edit.

Figure 2: Opening the reporting period

Screenshot of authorised prescriber reports table on SAS and AP system

Step 4: Open an authorisation report

Each row represents an authorisation you hold. In the Actions column, select the arrow icon, then select Edit.

Figure 3: Open an authorisation report

Screenshot of list of products table in SAS and AP system

Step 5: Enter patient data

For each AP authorisation, enter the following patient data:

New patients

The number of patients who commenced treatment, or the number of devices supplied, during this reporting period.

Total patients

The total number of patients treated during the reporting period. This includes:

  • new patients
  • patients who commenced treatment in a previous reporting period and continued treatment during this period.

If no patients were treated you must enter the number zero. 

If an AP authorisation is no longer in use, you are encouraged to consider requesting withdrawal of the approval.

Multiple authorisations

If you held more than one authorisation for the same product and dosage form during a reporting period, patient data must be reported separately for each authorisation, based on the relevant approval and expiry dates.

Where approval periods overlap:

  • report patient numbers up to the expiry date of the first authorisation
  • report patients treated after that date under the subsequent authorisation.

If you prescribed a product to a patient for the first time under a specific authorisation, count that patient as both a new patient and a total patient for that authorisation. This applies even if you have prescribed a different product to the same patient under another authorisation.

Patient numbers must not be combined across multiple authorisations. Combined reporting will be identified as non-compliant. 

Figure 4: Enter patient data

Screenshot of popup box requesting patient data from SAS and AP system

Step 6: Save your data

Select Save. 

If you cannot save the data, check that:

  • both fields are completed
  • only numbers are entered.

Repeat Steps 4 to 6 for each authorisation listed in the reporting period. 

Step 7: Submit your report

Select Yes under the Privacy Statement, then select Submit.

Figure 5: Privacy Statement

screenshot of privacy statement acceptance from SAS and AP guidance

Contact

If you need help accessing the system, submitting your report, or withdrawing your authorisation, email SAS.Support@health.gov.au.

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