Labelling changes: information for health professionals
Clearer medicine labels
Quality Use of Medicines relies on clear medicine labels. To reduce medication errors, medicine labels need to be more consistent, with important information made more prominent and easier to read.
The TGA has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices about their medicines and to use them more safely.
We have developed posters targeted at healthcare professionals and consumers. These will be gradually released over the 4 year transition period.
Please download these 'Your medicine, your knowledge' materials to help raise awareness about medicine labelling improvements.
Information for health professionals
Information for consumers
What do you need to know about the changes?
Medicine labels are already starting to change.
We are encouraging consumers to continue to speak to their health professional if they have any questions about their medicines. Here is some information you might need to know about the improvements:
Under new rules active ingredients will be:
- more obvious on the front of the medicine pack
- located below or next to the medicine name on front panel
- in a larger minimum text size than old labels
- easier to compare between medicines.
You can help by assisting patients to understand what the active ingredient is in their medicine and where to find it on the label.
Under new rules:
- most over-the-counter (OTC) medicines will include a Critical Health Information in distinctive tables. This information will always be in a consistent order and will be easy to recognise;
- to improve legibility, all mandatory information must be in text colours that contrast strongly with the background; and
- more declarable substances, such as allergens, are now required on the label.
We are encouraging consumers to continue to speak to their health professional if they have any questions about their medicines. We have a dedicated consumer-focused allergies and medicines page where you can search the list of declarable substances for allergens.
Under new rules:
- prescription medicine cartons must include the medicine name on three non-opposing sides to improve identification of medicines in dispensaries.
- prescription medicines will require a dedicated 70 x 30 millimetre space for attaching a dispensing label unless:
- the medicine container is supplied in a primary pack that has a dispensing label space (the container does not need a space);
- the medicine is only for use in a clinical setting where self-administration will not occur;
- the medicine is a starter pack; or
- the medicine packaging is too small for medicine sponsors to fit the dispensing label space. In this case, medicine sponsors will be encouraged to rearrange information on the label to leave as much room as possible for the dispensing label, or consider alternative packaging.
You may wish to consider alternative dispensing labels, such as clear flags, for medicines that cannot fit a dispensing label.
Under new rules:
- there will be a longer list of substances that must be declared on a label if they are present in the medicine
- additional substances will need to be declared including crustacea, fish, eggs, soya, milk and tree nuts
- medicines may not include the new allergens on the label until the end of the 4 year transition period.
Sponsors will have four years to implement these changes and fully comply with the new rules. During this transition period, it may be difficult for consumers to know whether their medicine's label includes the more comprehensive list of potential allergens. For this reason, the TGA has been undertaking targeted communications to consumers regarding the changes and specifically advising them to 'keep asking your doctor, pharmacist or other health professional about food allergen content in medications'.
If you are treating patients with known allergies, consider discussing these labelling changes with them (graphics showing where to find allergen information on their medicine's label is now available on the Allergies and medicines page on the TGA website). In particular, it may be important to ensure patients with less common allergies understand that some potential allergens will still not be covered in the new labelling rules. Additionally, during the transition period, you may need to contact the sponsor of a specific medicine to confirm if it contains any potential allergens (these contact details are provided on the medicine label).
- Medicine sponsors have until September 2020 to make changes to their labels and sell out old stock.
- You are still allowed to use medicines that are already on the shelf or in dispensaries after this date.
- It is especially important to make sure that patients who may be sensitive or allergic to certain substances are aware that allergens may not be declared on old labels.
Updated medicine ingredient names
- Australian medicine ingredient names are changing to align with names used internationally.
- Most are minor changes. More significant changes will continue to use both the old and new name on the label for a period. See the Updating medicine ingredient names page for more detail.
- For more information, including a list of affected ingredients see the Updating medicine ingredient names page on the TGA website.
If you have any questions or comments about medicine labelling please contact us: firstname.lastname@example.org.