Changing the sponsor of therapeutic goods
The 'sponsor' of therapeutic goods here refers to the person or company in relation to whom goods are registered, listed, or included in an entry in the Australian Register of Therapeutic Goods (ARTG).
Changes to the sponsorship of therapeutic goods in an entry in the ARTG occur where:
- the sponsor dies, is made bankrupt, or (if they are a company) the business is wound up, or
- the sponsor transfers or assigns its therapeutic goods business or their interest in inclusion of the goods in the Register to the person to whom the business or interest is transferred or assigned (the new sponsor).
As a result of such events, the new sponsor becomes responsible for the therapeutic goods in the ARTG entry, and must notify us of that event.
You, as the sponsor, are also required to notify us if you change your name, or amalgamates with another company under another name.
Changing the name of the registered therapeutic goods
If you are the new sponsor of registered therapeutic goods and you decide to change the name of the goods (perhaps because it contains the name of the former sponsor), you will need to make an application to register the product under its new name on the ARTG under section 23 of the Therapeutic Goods Act 1989 (the Act). This is because once you rename the product, under subsection 16(1) of the Act, it will be taken to be separate and distinct goods from the one registered on the ARTG.
The same rule applies to listed goods.
When does a new sponsor become responsible for the ARTG entries?
We do not make that determination. It is determined by the timing of the relevant event (e.g. the transfer of the business) as set out in regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.
Once a transfer or change occurs, the new sponsor is the person or business responsible for any relevant ARTG entries, regardless of whether:
- we have been notified of the transfer or change, or
- we have updated the ARTG entries of the relevant therapeutic goods.
Sponsors (and prospective new sponsors) should get their own advice about:
- the impact of regulations 10AB, 10AC (in relation to listed and registered therapeutic goods), regulations 10F and 10FA (in relation to medicinal devices) and regulations 10H and 10HA (in relation to biologicals) on their status; and
- their obligations under therapeutic goods legislation when sponsorship is transferred or the sponsor's name is changed.
Why is notifying us important?
- It allows us to continue the effective post-market monitoring of therapeutic goods that are marketed in Australia; in particular, the capacity to ensure recalls of products is effective.
- If information we hold about the identity of the current sponsor is not up to date, the new sponsor may not be aware of relevant information or documents that we require.
- Regulatory action may be taken by us that could result in goods being cancelled from the ARTG (for instance, if the new sponsor does not respond to a requirement to provide information).