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ARGOM Appendix 3: Guidelines on presentation aspects of OTC applications
A product's label (as defined in the Act) includes the label attached to the container (e.g. bottle, tube or blister pack), the primary pack (e.g. carton) and any printed information supplied with the container or primary pack (e.g. package insert).
Copies of all draft product labels (including package insert) should be provided with applications to register new products or vary the labelling of current products. Where the only difference in labelling between pack sizes is the quantity, only one set of labels need to be submitted, provided that an assurance to that effect is supplied with the application.
If possible, full scale, full colour draft labels or mock-ups of the proposed pack should be provided with the application to allow a thorough assessment of the product's presentation. If colour labels cannot be provided at the time of submission of the application, text or black and white label mock-ups should be provided. However, colour labels will be required for evaluation prior to approval of the product. This will allow the TGA to fully evaluate aspects of the labels such as umbrella branding issues, the appropriateness of any proposed label graphics, and the presentation of indications and other label claims. In the case of products where 'umbrella branding' issues apply (refer to 'Section 2.2 'Umbrella'/Family brand names'), colour labels will be required as early as possible during the evaluation process. The colour labels or mock-ups should be provided in hard copy and in electronic copy.
Labels should comply with the latest versions of the following documents:
- Therapeutic Goods Order No. 69 (TGO 69) - General requirements for labels for medicines (the Labelling Order)
- Required advisory statements for medicine labels (RASML)
- ARGOM Appendix 5 Guidelines on OTC applications for specific products
- Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
- Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990
- Therapeutic Goods Advertising Code
- Code of practice for the tamper-evident packaging (TEP) of therapeutic goods
Other Commonwealth and State/Territory legislation may need to be taken into account when labelling medicines, for example, the Competition and Consumer Act 2010, Part 5-3, Country of origin representations, Commerce (Trade Descriptions) Act 1905 and Commerce Imports Regulations 1940, Therapeutic Goods Order No. 80 (TGO 80) - Child-resistant packaging requirements for medicines, Trade Measurement, Packaging Covenant.
Note: The above list is indicative only.
3.1 Statement of ingredients
The Labelling Order specifies how active ingredients should be declared on labels. The Labelling Order also requires the disclosure of specified excipients (e.g. those that are known to cause adverse effects in some individuals; antimicrobial preservatives in products for topical use) and specifies how these are to be declared on labels.
Selective disclosure of excipients, other than those required to be disclosed by the Labelling Order, must be justified (e.g. flavours, colours). Where the selective disclosure of individual excipients could imply that the excipient may have a therapeutic activity, this will not be accepted. Claims relating to excipients will be assessed by the TGA on a case-by-case basis in the context of the overall registered product.
3.1.1 Absence of excipient
A product label may include a statement that the product does not contain an excipient known to cause adverse effects in some individuals (e.g. gluten free, sugar free, alcohol free, lactose free), provided the statement is true. If including any statements that the product is 'free from...', the sponsor should provide written assurance in their submission that the product is free from the stated substance.
Inclusion of a statement that the product contains no sugar (e.g. 'sugar free') is acceptable provided the formulation does not include sucrose, glucose, fructose, maltose, honey or other sugars with a cariogenic potential or the potential to affect people with diabetes.
If the formulation includes a proprietary ingredient, the sponsor should check with the manufacturer or supplier of the proprietary ingredient to ascertain that it does not contain any component it is claimed to be 'free of' on the label. The sponsor should also check whether the proprietary ingredient contains any specified excipient that must be declared on the labels, in accordance with the Labelling Order.
3.2 Directions for use and dosage
Directions for use must clearly identify the dose and dosage frequency for each target population for which the product is intended (e.g. 'Adults and children over 12 years: two tablets twice daily; Children 6 to 12 years: one tablet twice daily'). For the appropriate use of some products, a statement regarding 'duration of use' should be included in the directions for use on the labels. If the product is not intended for use in children, the label should specify that the dose is an adult dose (e.g. 'Adult dose: 10 mL'). The maximum daily dose for each age group should be included where appropriate.
3.2.1 Dosing for adults and/or children over a specified age
Where the labelling only includes doses for adults and/or children over a specified age (e.g. adults and children 12 years and over; adults and children 6 years and over; children 6-12 years), the labels should include a statement such as 'Do not give to children under xx years / months' or 'Not recommended for children under xx years / months'.
3.2.2 Directions to seek advice from doctor or pharmacist
Inclusion of a label statement such as 'Do not give to children under xx years / months except on medical advice' or 'Not recommended for use in children under xx years / months except on the advice of a doctor (or pharmacist)' is only acceptable if the product has a TGA-approved published product information (PI) that the doctor or pharmacist can refer to in determining the appropriate dose for this age group.
3.2.3 Directions for symptomatic relief
The directions for products which are intended for symptomatic relief (e.g. cough and cold preparations) should include a qualifier such as 'as required' or 'when necessary' after the specific dosage frequency (e.g. 'take one tablet in the morning when necessary'). The directions 'as required' or 'when necessary' are not acceptable on their own.
3.2.4 Dosing for liquid, solid or semi solid products
For liquid products, recommended doses should be able to be measured using commonly available metric measures. If the recommended doses cannot be measured using a readily available metric measure, a suitable measure should be provided in the pack. Sponsors intending to supply a measure with the product should refer to the ARGOM Appendix 2 Guidelines on quality aspects of OTC application: Section 8.1 Measuring devices or other dose delivery devices.
For solid or semi-solid dose forms such as powders or gels, if the labelled dose corresponds to the quantity contained in one or more level 5 mL medicinal measuring spoons, a dosage stated in that way would be acceptable (e.g. 'Adult dose: one level 5 mL medicinal measuring spoonful...').
References to a culinary 'spoonful' (e.g. teaspoon, dessertspoon, tablespoon, etc.) will not be accepted.
3.3 Warning statements and contraindications
Product labels must include the advisory statements required by the Required Advisory Statements for Medicine Labels (RASML). Statements specified in ARGOM Appendix 5 Guidelines on OTC applications for specific products should also be included on the label and/or package insert, as appropriate. The TGA may request the inclusion of other warning statements and/or contraindications on the product label and/or package insert during evaluation of an application to register or vary the registration of a product.
3.4 Pregnancy warning statement
Where a product contains active ingredient(s) that are included in category 'B' (including 'B1', 'B2, 'B3') or category 'C' in the Prescribing medicines in pregnancy database on the TGA website, the primary pack label should include a statement advising consumers who are pregnant or who may become pregnant to check with their doctor or pharmacist before taking or using the medicine. Inclusion of this statement on the primary pack label will allow consumers who are pregnant or who may become pregnant to see this information before purchasing the product. This statement is not required on the labels of products for which all the active ingredient(s) are in category 'A'.
The primary pack labels of products that contain active ingredient(s) that are in category 'D' or category 'X' in the Prescribing medicines in pregnancy database must include a statement advising consumers who are pregnant or who may become pregnant that they should not use this product. In some cases (e.g. products for use as nicotine replacement therapy), the TGA may accept use of a substance in category 'D' during pregnancy, on the basis of risk-benefit analyses.
3.5 'Fast' or 'rapid' claims
All 'fast' or 'rapid' claims must be supported by appropriate data. The examples below are provided for guidance only. The ultimate acceptability of any 'fast' or 'rapid' claims must be evaluated within the overall context of the product.
Fast or rapid claims are appropriate only when they are made in relation to a condition or symptom where speed of onset is relevant (e.g. pain). Such claims may not be appropriate for chronic conditions or those not requiring immediate relief or if the pharmacokinetics or mechanism of action of the medicine precludes a fast action.
In general, claims that imply fast action or fast relief should be supported by clinical data. However, in some circumstances (described below), dissolution data can be used to support certain fast or rapid claims.
Circumstances when clinical or pharmacokinetic data are required:
- Where the words 'rapid' or 'fast' are intended or likely to be taken to be part of the product name, the applicant is expected to provide clinical efficacy data which compares the efficacy of the product against an appropriate Australian comparator demonstrating significantly earlier onset of clinically relevant efficacy. If a product is to be taken with food, then efficacy studies in the fed and fasted states are also required.
- Claims of fast absorption require pharmacokinetic data. Where the claims imply 'faster absorption', comparative pharmacokinetic data are required against the product or products with which the comparison is being made. Comparative dissolution data alone cannot be used to support such claims.
Circumstances when dissolution data alone may support certain fast or rapid claims:
- Where appropriate to the dosage form and indication (e.g. an analgesic tablet for relief of pain), 'fast' claims may be included on the label on the basis of dissolution data showing > 70% dissolution of the active ingredient(s) within 15 minutes. To support the claim, dissolution testing should be performed at expiry (or on aged samples from the stability trials). Where the product has not been tested at expiry, the available stability data on aged samples should not indicate that the product is likely to fail dissolution (NLT 70% in 15 minutes) at expiry. If the data provided indicate that the dissolution limits (NLT 70% in 15 minutes) may not be met, then the 'fast' claim will not be accepted.
Note: Fast relief of fever or inflammation are considered to be inappropriate claims and will not be accepted.
- Where 'fast' or 'rapid' action claims are justified on the basis of dissolution data, such claims are to be linked to the symptoms/conditions that are relieved and are to be displayed/included as part of the indications on the label (e.g. "For fast relief of itchy eyes associated with hay fever"). Unqualified or stand alone 'fast' or 'rapid' claims that are prominently displayed on the label are likely to mislead the consumers and are therefore considered to be unacceptable.
Dissolution data alone cannot be used to support a 'fast' claim if the medicine is of a known slow onset, or if the pharmacokinetics or mechanism of action of the medicine precludes a fast action. For example, a medicine like loperamide which acts in the lower intestine may dissolve quickly but cannot be accurately described as fast because of the length of time required before the onset of action.
For fast or rapid claims not included in these scenarios, contact the TGA to discuss the data requirements.
3.6 Distinctiveness of labels
To reduce the possibility of confusion among consumers, the presentation of new products (including pack design, font size and type, logos, etc.) should be such that the new products are clearly distinguishable from existing products.
3.7 Graphics, logos and symbols
Non-corporate graphics, logos or symbols on labels should be consistent with the product's approved details, including being appropriate for the claimed therapeutic use of the product. For example:
- an illustration of a baby would be inappropriate for a product with a dose range starting at 2 years;
- a graphic highlighting joints would be inappropriate for a product that is indicated for use only on soft tissue injuries.
3.8 Reference to other products
Situations where other products may be referred to in labelling include:
- reference to more suitable dosage forms within the same range for different age groups (see ARGOM Appendix 5 Guidelines on OTC applications for specific products: Paediatric products - Solid dose products)
- reference to another product that can be used in conjunction with the product, where appropriate
- reference to a sponsor's other products within the same product range that have the same trade name as the current product, where appropriate.
Note: The products referred to must be approved for supply in Australia.
References to other products which are capable of confusing the consumer (e.g. inclusion on the front panel of a label of the statement 'from the makers of Xxx' or that it has 'the same active ingredient as Xxx' may lead some consumers to think the product is 'Xxx') is unacceptable.
Statements comparing a product with other products or treatments will only be accepted where satisfactory evidence is provided to support the claim. These claims must also comply with Clause 4.5 of the Therapeutic Goods Advertising Code . See also the ASMI Code of Practice, clauses 5.1.3 and 5.2.
Labels must not contain or imply endorsement of the product except as permitted by the Therapeutic Goods Advertising Code (Clause 4.6).
The sponsor should remove an endorsement from the labelling (by way of a notification application to the TGA) once the endorsement is no longer applicable.
Labels may include reference to sponsorship of the product (e.g. Pink Ribbon Campaign, Cancer Council Australia, Surf Life Saving Australia) when in compliance with clause 4.6 of the Therapeutic Goods Advertising Code. Sponsors should provide evidence that claims relating to any such sponsorship are true, for example, a letter from the relevant organisation showing that claims relating to any such sponsorship are true.
Where the sponsorship includes a potential restricted representation, e.g. Cancer Council Australia, prior approval for the use of the restricted representation must be sought in writing from the TGA.
3.12 Internet addresses
The inclusion of internet addresses on labelling is only acceptable if the sponsor provides an assurance that the information about the product included on the website (including any direct links from that website) is consistent with the information approved by the TGA for that product. If such an assurance cannot be provided, the internet address should be deleted from the labelling.
3.13 International labels
Products that are supplied in Australia and also exported to another country may include overseas product registration numbers required by the importing country. Labels intended for export only should be submitted to the Exports Section of the TGA.
3.14 Foreign language text on labels
For labels on medicines supplied in Australia a certified English translation of any other language must be provided to verify that the text is consistent with the English language text and that the label, including the product name, does not include or imply any additional indications.
3.15 Package inserts
Package inserts are considered part of product labelling (refer to the definition of 'Label' in the Act) and require approval by the TGA. A package insert should be provided if the primary pack label does not contain all the information which the TGA considers to be necessary for the safe and appropriate use of the product by the majority of consumers (including indications, directions for use, and important contraindications and precautions). The TGA may request the provision of a package insert in cases where this applies, if the sponsor has not already submitted a package insert.
A package insert may be in the form of a consumer medicine information (CMI) document if there is an approved product information (PI) document for the product (refer to 'Section 4 Product information' and 'Section 5 Consumer medicine information').
3.16 Requirements for labels and or package inserts following changes to scheduling classification
When the classification of a product is changed following a decision by the delegate, changes will be required for the labels, package inserts, PI and CMI (see also 'Section 4.2 Requirements for the PI following changes to scheduling classification' and 'Section 5.1 Requirements for the CMI following changes to scheduling classification'). The sponsor is responsible for ensuring that labelling and any other changes arising out of a rescheduling decision are submitted for approval by the TGA (see 'Section 3.17 Changes to labels and/or package inserts', 'Section 4.4 Changes to the PI' and 'Section 5.2 Changes to the CMI'). The products must not be supplied under the new scheduling arrangements prior to the effective date as specified in the SUSMP.
3.17 Changes to the labels and/or package inserts
Changes to the labels or package inserts of existing products will require approval from the TGA34. Relevant changes to labels should be highlighted (e.g. through the provision of 'track changes' labels or a table detailing all the proposed changes).
Where changes are made to a package insert, a variation application should be submitted to the TGA requesting approval of the amended package insert. Approval by the TGA will be required if a package insert is no longer to be provided by the sponsor with the product.
- Refer to the application process for variation to the register (to be finalised)