New look, same medicine
The Therapeutic Goods Administration (TGA) has introduced changes to requirements for labels on prescription and over-the-counter medicines – including herbal medicines and multivitamins – which will make it easier for consumers to find important information. The changes will bring our labelling regulations into line with international best practice.
The keys changes are:
Active ingredient/s to be more prominently displayed
While the medicine name will still be the most prominent feature of the label, the active ingredient/s are to be clearly displayed in large print either directly under or next to the name. This will help reduce confusion if consumers swap brands of a particular medicine – from a big brand to a generic, say – or take more than one medicine with overlapping ingredients, like cough and cold medicine as well as a painkiller.
Critical health information will be easier to find
Information about the medicine and its active ingredients, what it's used for, warning statements and directions for use will be displayed more consistently and will be easy to recognise.
Warning statements, including allergens, to be highlighted
Any applicable warning statements, such as when a medicine should not be used in certain situations, or by certain people, or when serious side effects may occur, are to be made clearer. The list of potential allergen warnings has been expanded, and includes tree nuts, crustacea, fish, eggs, soya and milk/lactose, as well as gluten, peanuts and bee products.
More space for dispensing labels on prescription medicines
Prescription medicines now have a minimum specified space available for sticking the dispensing label, so it doesn't inadvertently cover any important information on the package.
Some changes to active ingredient names
The names of certain ingredients are changing in line with international names for the same product. In many cases it's just a small spelling change – amoxycillin becomes amoxicillin, for example, and oestrogen-related names are losing their initial 'o', so oestradiol becomes estradiol.
Check the TGA list of ingredient name changes to see if any of your medicines are affected.
What else is on the label?
The TGA also alerts consumers to other useful information on the pack, including storage advice, expiry date and batch number for reporting problems. Consumers should also check for an AUST R or AUST L number, which is required for medicines, including alternative medicines, multivitamins and fish oil, to be sold in Australia.
The main difference between registered (AUST R) and listed (AUST L) medicines is that registered medicines are more tightly regulated and controlled by the TGA, and are evaluated for quality, safety and effectiveness, whereas listed medicines are not. CHOICE was hoping to see additional information clarifying this important difference, ensuring consumers understood that AUST L products had not been assessed to see if they work. Unfortunately this did not eventuate.
When does it happen?
The new label format was introduced in September 2016, with sponsors given until September 2020 to ensure all products sold comply with the new requirements. This gives sponsors time to sell existing stock and make necessary changes to packaging production processes. In the meantime, you may still see old labels on sale.
TGA - Australian medicine labels are becoming clearer
NPS MedicineWise - Your medicine labels are changing