ASMI has said country of origin statements, graphics and visual representations should not be mandatory for therapeutic goods labels, in its submission to the Government’s review of country of origin labelling.
“ASMI supports sponsors who wish to include a country of origin statement on therapeutic goods labels,” Steve Scarff, ASMI regulatory and scientific affairs director says.
“However, inclusion of the statement should not be mandated because all therapeutic goods are already highly regulated for safety and quality and all are manufactured in sites that have been approved by the TGA – including overseas sites.
“The supply chains for therapeutic goods may be complex, involving multiple parties, markets and TGA approved site,” he says.
“The more complex a product’s supply chain, the more difficult it will be to identify the point at which it is ‘substantially transformed’ and its precise ‘country of origin’.
“Also, where a label is used in more than one market and a country of origin statement is included, then the statement will need to comply with the (potentially divergent) legal requirements in each of the markets,” he says.
In its submission ASMI proposed several reforms:
- The current requirements, as they apply to therapeutic goods, could be illustrated through ACCC guidelines and Frequently Asked Questions.
- Any revised Australian requirements should, as far as practicable, be harmonised with the requirements in other comparable markets.
- The current safe harbour defence of substantial transformation plus 50 per cent or more of total costs should be retained in its current form for therapeutic goods.
- If the 50% or more of total costs test is removed, industry will require a clear definition of substantial transformation. A transparent consultation with industry before implementation would be required.