Labelling changes: information for health professionals

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 (see What will I see in the Critical Health Information table);
• 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.

• Critical health information (pdf,31kb)
  

The critical health information table has been introduced to help consumers find important information they need to safely use their medicine. You can help by bringing this information to your patients' attention

The critical information in this table will always be in the same order. Although there may be slight differences in phrasing, the same type of information will be included under each heading.

These are the headings in the order you will see them in the table and the information you will find under each:

• Active ingredients
  • The active ingredient names and their quantity
• Indications
  • The indications or uses for the medicine
• Warnings
  • These cover all the mandatory warning statements such as use in pregnancy or allergy alerts
  • These also include any advisory statements such as 'drink plenty of water', 'see your doctor if symptoms persist', 'contains X as preservative' etc.
  • Additional warnings specifically about how the medicine can be used may be located under the 'directions for use' heading, - for example 'do not take for more than 7 days'.
• Directions for use
  • Includes information about how to safely use the medicine. This information may be expanded on a pack insert.
  • Some warning statements may appear here if they relate directly to directions for use, such as duration of use.
• Other information (optional heading)
  • This is an optional heading and may not appear on all OTC medicines
  • Only certain additional information will be located here: storage details, tamper evident features, sponsor/distributor contact details and a full list of ingredients.

Under the 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
• medicines with old labels not including new allergens may still be available on shelves and in warehouses as this stock is gradually used up.

Sponsors have had four years to implement these changes and fully comply with the new rules. During the transition period, and until stock with old labels is gradually used up, 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, 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 had until 31 August 2020 to make changes to their labels.
• All medicines made after 31 August 2020 must comply with the new labelling requirements.
• After the transition ends, you can still purchase, use and store medicines with the old and new labels.
• 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.