HSV bulk purchasing arrangements and the regulatory environment

The Therapeutic Goods Administration (TGA) requires that suppliers or sponsors and/or their wholesalers are able to identify precisely where affected goods have been distributed – including where bulk purchasing arrangements are in place – in the event of a product recall.

The TGA has developed a process to assist state and territory coordinators in identifying the location of affected goods within their jurisdictions.

When operational, HSV’s bulk purchasing arrangements will support an effective product recall process in line with TGA objectives. These arrangements provide clarity on how HSV will support supply chain transparency and interact with sponsors’ or suppliers’ ability to meet legislative requirements for product recalls:

• If advised by a supplier of a product recall, HSV is responsible for tracking in-stock goods via our purchasing and ordering systems and advising health services of the recall.
• HSV will provide relevant supply chain data of in-stock goods to assist suppliers in product tracking.
• Health services retain responsibility for managing recall arrangements.