ASMI supports voluntary country of origin labelling for therapeutic goods

30 June 2015

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In its submission to the Federal Government's review of country of origin labelling, the Australian Self Medication Industry (ASMI) said country of origin statements, graphics and visual representations should not be mandatory for therapeutic goods labels.

Steve Scarff, ASMI Regulatory and Scientific Affairs Director said: "ASMI supports sponsors who wish to include a country of origin statement on therapeutic goods labels.

"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 Therapeutic Goods Administration (TGA) - including overseas sites.   

"The supply chains for therapeutic goods may be complex, involving multiple parties, markets and TGA approved sites. 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 added.

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 (FAQs)
  • 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 per cent 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.



For more information or to arrange a media interview, please contact:

Marie Kelly-Davies

Communications Manager, Australian Self Medication Industry (ASMI)

P: 9923 9410 M:0408 256 381      E:







About ASMI:  The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines (CM). ASMI members make up 85 per cent of the $4bn Non-Prescription Medicines market. Membership totals 50 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. ASMI's mission is to advance consumer health through responsible self-care.  This means driving a viable and responsible industry and empowering the consumer with evidence-based products and information with the aim of improving health and wellbeing. To find out more about ASMI or how to become an ASMI member, please visit (