Private ruling: Goods and services tax (GST) and supplies
Date of advice: 1 July 2019
Published: September 2019
Ruling period: The date of issue of this private ruling - ongoing
Date scheme commenced: 1 July 2018

Ruling: Q1: Can your supply be GST-free to individual patients under section 38-50 of the A New Tax System (Goods and Services Tax) Act 1999 (GST Act) even if the trademark is not listed on the Australian Register of Therapeutic Goods (ARTG)? | A1: Yes, the supply of the medical product will be GST-free to individual patients under section 38-50 of the GST Act. | Q2: Given that the packaging clearly specifies it to be a "Pharmacist Only Medicine" under s38-50 of the GST Act, can it be sold as GST-free to individual patients? | A2: Yes, the supply of the medical product will be GST-free to individual patients under section 38-50 of the GST Act. | Q3: Given that the product is registered as a medical device with the ARTG and this device is not on Schedule 3 Medical Aids and Appliances of s 38-45 of the GST Act, does this preclude it from being GST-free to individual patients? | A3: No, the supply of the medical product will be GST-free to individual patients under section 38-50 of the GST Act.

Relevant facts and circumstances: You have been appointed as the exclusive distributor of a product designed for the treatment and relief of a condition experienced by female patients. In order to distribute the product in Australia, you have created your own trademark. You have not sought a separate TGA application as it is clearly stated on its packaging that this product is sold as "Pharmacy Only Medicine".

Relevant legislative provisions: A New Tax System (Goods and Services Tax) Act 1999 section 38-45 | A New Tax System (Goods and Services Tax) Act 1999 section 38-50

Reasons for decision: Summary: Section 38-50 of the GST Act outlines the circumstances in which the supply of a drug or medicinal preparation will be GST-free. Specifically relating to your circumstances, a supply of a drug or medicinal preparation is GST-free if, under a State law or a Territory law in the State or Territory in which it is supplied, the supply of the drug or medicinal preparation to an individual for private or domestic use or consumption is restricted but may be made by: · a medical practitioner, dental practitioner, or pharmacist, or · any other person permitted by or under that law to do so. The restrictions imposed by the TGA have effect upon the advertising and distribution of the product across all States and Territories. As your product is packaged and sold as Pharmacy Only Medicine, it meets the requirements of s38-50(2) and will be GST-free when sold to an individual for private or domestic use or consumption. It does not matter what product or trademark name is used for the purposes of the GST Act. It is the actual drug or medicine that is GST-free rather than a specific brand.