TGA SAS/AP Authorisation

Supply of finished MCP by a sponsor

In order for a sponsor to comply with the requirements of the exemption, finished MCP that has been imported or manufactured under the exemption must only be supplied under one of the following approved alternative pathways:

1. the authorised prescriber scheme (AP)
2. the Special Access Scheme B (SAS B)
3. a clinical trial notification (CTN), or
4. a clinical trial approval (CTA).

Supply of finished MCP by persons other than the sponsor

The TG Act provides that it is a criminal offence for a person who is not a sponsor of a therapeutic good to supply that therapeutic good to ‘another person who is not the ultimate consumer of the goods’ (including by wholesale) unless the goods are subject to a relevant exemption, approval or authority. In the case of MCP, this will generally be SAS B, AP, CTN or CTA, as discussed above.

Source: Australian Government, Department of Health, Therapeutic Goods Administration, Supply and wholesaling of medicinal cannabis products (MCP), Version 1.0, April 2021

How to associate a SAS-B or AP Authorisation to an order

Step 1: SHOPPING CART

When you are ready to confirm and place your order, select the shopping cart icon at the top right hand side of the portal.  This will take you to your shopping cart:

Step 2: ADD SAS/AP REFERENCE TO EACH PRODUCT

Select 'Add comments' under each product

Add the SAS or AP Reference Number to the comments box

Ensure you repeat these setup for all products in the shopping cart

Step 3: CHECKOUT

When checking out, please ensure that:

• Your Pharmacy PO Number or SAS/AP Reference is inserted into the 'Purchase order number' section
• Add any additional SAS/AP References are inserted into the 'Add notes about your order' section
• Attach/Upload any SAS/AP letters in the 'Add attachment' section