TGA medicine labelling and packaging review
24 May 2012
Appendix 1: Consolidated list of recommendations
1.1 The active ingredient(s) must be listed immediately below the brand name, with the first letter of the active ingredient directly below the first letter of the brand name.
1.2 On the front/main panel of the label, the active ingredient must have equal prominence with the brand name.
1.2.1 The intention of 'equal prominence' is for the active ingredient to be as easy to locate and identify on the label as the brand name.
1.2.2 The font size of the active ingredient must be at least 100% of the font size of the medicine brand name on the main/front label.
1.2.3 For improved differentiation between the brand name and the active ingredient there should be a difference in font style or letter spacing or font colour.
1.2.4 The active ingredient should begin with an uppercase letter but the remainder should be in lower case.
1.3 Where there are more than 3 active ingredients, the most abundant ingredients must appear on the main label immediately below the brand name and the names together with the quantities of every active ingredient are to be included on a side panel/label or on a rear panel/label for the product. (This does not apply to day and night preparations.)
1.4 For products containing day and night preparations that have different formulations, the composition of each tablet must be provided immediately below the brand name and the font size must be no less than 2mm in height on the main/front panel.
1.5 The active ingredient must be included with, and of equal prominence as, the brand name on at least 3 non-opposing faces of a carton.
1.6 Non-prescription medicines that contain paracetamol must include the following information on the front of the packaging. The information must be presented in bold text in letters of at least 1.5mm high and on a background that contrasts with the rest of the packaging:
"Contains paracetamol. X mg. Consult your doctor or pharmacist before taking other paracetamol products."
1.7 Non-prescription medicines that contain ibuprofen must include the following information on the front of the packaging. The information must be presented in bold text in letters of at least 1.5mm high and on a background that contrasts with the rest of the packaging:
"Contains ibuprofen. X mg. Consult your doctor or pharmacist before taking other medicines for pain or inflammation."
3.1 Sponsors of new medicines will be required to submit evidence of risk assessment of the proposed labelling and packaging. The TGA will work with industry to develop guidance for this assessment, which may include consumer testing or risk assessment checklists similar to those used in other countries. The TGA is investigating methods to electronically screen proposed brand names against already existing brand names to identify potential LASA names.
3.2 In relation to applications to include a new medicine in the Australian Register of Therapeutic Goods (ARTG), if the proposed medicine brand name differs from another product included in the ARTG by three letters or fewer, the presentation of the proposed medicine label and packaging must use colours and designs that contrast with the medicine label and packaging of the existing product. During the implementation of this change, the TGA will work with the medicines industry to develop guidelines to provide clarity about these proposed requirements.
3.3 In relation to applications to change the labelling and packaging of existing medicines, if the brand name of the medicine differs from another medicine included in the ARTG by less than three letters, the proposed changes must use colours and designs that contrast with the medicine label and packaging of the other medicine.
To reduce the risk of consumer confusion and medication errors caused by look-alike medicine branding, the TGA proposes the following regulatory options:
3.4 Products that are listed on the ARTG cannot be marketed under the same name as a registered medicine.
3.5 Medicines that contain the same quantity of active ingredient(s) cannot be selectively differentiated or marketed for a subset of symptoms or uses, unless the medicine has specific characteristics that make it more suitable for a particular symptom.
For example: Products cannot be marketed as "BRAND headache", "BRAND backache", "BRAND joint pain" if they include the same active ingredients in the same quantity.
3.6 The same brand name cannot be applied to products that have different active ingredients or combinations of active ingredients unless all of the following conditions are met:
- The active ingredients are closely related (e.g. different salts of the same pharmaceutical chemical), and
- The safety profile, efficacy and dosage regimen are similar.
Examples of the application of the above requirements include:
A brand name that has historically been strongly associated with a particular anti-histamine would not be permitted to be used for a new product with a different type of active ingredient, such as a corticosteroid or a different anti-histamine.
A well known combination product that contains paracetamol under a particular umbrella brand name would not be able to use this same umbrella brand name for another combination product that also contains ibuprofen.
4.1 Mandated information on labels and packaging of non-prescription medicines and complementary medicines is presented in a standardised Medicine Information box, based on the US FDA Drug Facts box. The mandatory headings are:
- Active ingredient, including the amount in each dosage unit
- Uses (indications)
- Warnings and Allergy Information (including when the product should not be used and when to consult with a doctor of pharmacist. This section also includes information about possible side effects and substances or activities to avoid. The final lines of this section should include information about preservatives in the product.)
- Directions/Dosage instructions
- Storage information.
4.2 The font height for information must be no smaller than 1.5mm, with heading height at least 2mm.
4.3 The Medicine Information Box must have a white background with black text. Headings must be highlighted or bolded so they are sufficiently emphasised.
4.4 Where there is insufficient room on a single face of a package, the box may be split over more than one face. However, the overall format of the information is to remain the same. In these instances a pack insert may also be included containing the Medicine Information Box as a continuous table.
4.5 Information about the presence in the medicine of an allergen listed in Schedule 1 of TGO 69, which may be amended, must be included under the heading Warnings and Allergy Information.
4.6 For products containing more than 3 active ingredients, or products in small containers, there may be insufficient space on the medicine container or primary packaging for a complete Medicine Information Box. In these cases a complete Medicine Information Box should be included as a pack insert. The minimum information to be included on the label will include information under the following headings:
- Warnings and Allergy Information.
Where space restrictions do not allow for the required information to be provided in the Medicine Information Box, an alternative arrangement or formatting of information should be provided to the TGA for assessment and approval, together with a justification for non-standardised presentation. This may include breaking the information over more than one panel, or reduction in font size.
5.1 A designated space of 70 x 30 mm, consistent with international best practice, must be provided to accommodate the dispensing label.
5.2 Where a clear space is not practical due to constraints from packaging size and shape, the information should be arranged so that information that is likely to be obscured is the same as the information repeated on the label. The area for placement of the sticker should be illustrated by corner placement marks on the packaging.
5.3 For small containers, for example eye drops and ointments, where a designated space of 70 x 30 mm is impractical, a clear space should be provided to affix the edges of a folded dispensing label.
6.1 The brand name of the medicine, the active ingredient and amount of active ingredient, batch number and expiry date must be repeated at least once every two units.
6.2 Where strips can be segmented, the brand name, the active ingredient and amount of active ingredient, batch number and expiry date is to appear on each segment.
6.3 A maximum of 3 active ingredients should be listed on each segment / each 2 units of a blister strip for registered medicines.
6.4 Where there are more than 3 ingredients, for example multi-vitamins packaged this way, it may be sufficient to include a single list of active ingredients printed on the foil of each blister strip. Alternatively, the brand name, together with batch number and expiry date, should be repeated on the foil.
For oral contraceptives and other medicines that have a "race track" format to support their safe use, the TGA proposes the following requirement:
6.5 Blister strips that have a "race track format" must include the trade name, the active ingredient(s) and their amount(s), batch number and expiry date in a single location.
The following requirements are proposed for medicine containers with a nominal capacity of 20 millilitres or less:
7.1 These containers must be enclosed in a primary pack that fully complies with all labelling requirements and that includes a pack insert that provides detailed instructions for use.
7.2 The label on the container must include the following details in a letter height of not less than 1.5 millimetres:
- The brand name of the medicine
- The name(s) of all active ingredients in the medicine
- For ophthalmic preparations the name of any antimicrobial preservatives in the medicine
- Where there are more than three active ingredients, the three most abundant ingredients are to be included on the label of the container and the complete list of ingredients on the primary packaging and the pack insert
- The batch number of the medicine
- The expiry date of the medicine
- If an injection, the approved route of administration
- If an ophthalmic preparation for multidose use, a statement to the effect that the medicine should not be used later than four weeks after the container is first opened
- If a solid ophthalmic medicine for preparing eye drops for multidose use, a statement to the effect that the medicine should not be used later than four weeks after the container is first opened.
7.3 A clear space should also be provided to allow a pharmacist to affix a dispensing sticker. This space need not be the size of a standard dispensing sticker (80 x 40 mm), but should allow a folded sticker to be attached like a flag without obscuring information.
8.1 Advertising material will not be permitted to be included as a separate pack insert or incorporated into an approved pack insert.
8.2 A pack insert must be in a form separate to the packaging; ie it cannot be printed on the inside of a carton.
9. It is proposed that this expert advisory body will provide advice to the TGA on product-specific as well as general matters relating to medicine labels and packaging.
Web page last updated: Wednesday, 23 May 2012