The Australian Self Medication Industry has welcomed publication of the new Therapeutic Goods Order, marking the conclusion of the TGA’s medicines labelling review
“We greatly appreciate the TGA’s inclusive, collaborative and transparent approach throughout the lengthy consultation process, which ensured we achieved the right outcome,” says Deon Schoombie, ASMI’s CEO.
“A tremendous amount of work was put into the consultation process by all stakeholders—ASMI members, industry partners and other stakeholders, as well as the TGA, to ensure an optimal approach was adopted to better support the consumer with effective product labelling for non-prescription medicine products.”
The labelling review commenced in 2012, with impractical reforms set out in the original proposal which would have significantly impaired consumers’ ability to recognise and select well-known non-prescription medicines, says Dr Schoombie.
These proposals made no distinction between the different ways that non-prescription and prescription medicine labels are used by consumers, despite the different needs of consumers when selecting and using these different types of medicines.
For non-prescription medicines, the label is the most important source of information for the consumer, he says.
It should provide sufficient information for consumers to appropriately select and safely use medicines.
In amending the requirements for labelling of non-prescription medicines, the challenge was to improve labelling to meet the information needs of consumers and healthcare professionals but also ensure that changes were sensible and practical from an industry perspective, Dr Schoombie says.
ASMI says it is confident that the new labelling order addresses these challenges, and that many of the needs and expectations of stakeholders have been met.
There are two separate labelling Orders – TGO 92 for non-prescription medicines and TGO 91 for prescription medicines as well as interpretive guidance.
Although the majority of non-prescription medicines will accommodate the new labelling requirements, it is possible that some existing products may have difficulty meeting the new requirements and will require TGA exemptions.
The practical implementation of the new requirements may also reveal the need for further tweaking.
For non-prescription medicines, the major changes are an increase in the prominence of active ingredients on the front of pack and for registered medicines, a standardised format for critical information on the back of pack.
The new requirements will not change the overall appearance of well-known non-prescription medicine brands, which is important for consumers.
ASMI also welcomes the transition period of four years, which it says allows adequate time to phase out current packaging before transitioning to the new format.
It will also occur concurrently with other labelling changes such as the international harmonisation of ingredient names.