Therapeutic Goods Regulation - Change or transfer of 'sponsor'
From 17 August 2016 changes will come into effect regarding 'sponsorship transfer’ and ‘changes in sponsor name’ provisions in the Therapeutic Goods Regulation 1990.
A 'sponsor' of therapeutic goods is a person or company that has goods on the Australian Register of Therapeutic Goods under their name.
The changes ensure more consistent arrangements across the 3 different kinds of therapeutic goods (i.e. listed and registered goods, medical devices and biologicals) and are not substantive changes to the operation of the current provisions.
Specifically, updated notification requirements apply where a sponsor becomes bankrupt, is wound up or its business is assigned or transferred, with the Therapeutic Goods Administration (TGA) to be notified within 3 months of the event. Similar notification requirements apply where there has been a change of sponsor name.
More information regarding the amendments is available on the TGA website.