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Assessed listed medicines evidence guidelines

Version 1.1, August 2018

17 August 2018

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7. Presentation

The presentation of therapeutic goods is the way in which the goods are presented for supply, and includes matters relating to the name, labelling and packaging of the goods, and any advertising or other informational material associated with the goods.

For example, aspects of the product that are considered to comprise the 'presentation' include:

  • the name
  • indications
  • directions for use
  • warning and cautionary statements
  • packaging
  • dosage form
  • logos, symbols and pictures.

Please note that Product Information documents that contain technical information relating to the safe and effective use of a medicine are generally not required for assessed listed medicines, however if included, they may form part of the 'presentation'.

7.1 Unacceptable presentation

The presentation of assessed listed medicines is evaluated pre-market. A product will not be approved if the presentation is deemed to be unacceptable. Unacceptable presentation is defined in subsection 3(5) of the Act as follows:

"the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:

  • (a) if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or
  • (b) if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or
  • (c) if the label of the goods does not declare the presence of a therapeutically active ingredient; or
  • (ca) if the therapeutic goods are medicine included in a class of medicine prescribed by the regulations for the purposes of this paragraph—if the medicine's label does not contain the advisory statements specified under subsection (5A) in relation to the medicine; or
  • (d) if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or
  • (e) in prescribed cases."

Examples of unacceptable presentations include, but are not limited to:

  • therapeutically active ingredients are present in the formulation but not declared as such on the label (and/or misleadingly declared as 'excipients' in the application);
  • statements are made attributing a therapeutic role to ingredients that have not been declared as active ingredients, that is: excipient ingredients;
  • statements or pictures suggest that the product has uses or actions different from, or in addition to, the indications for use included in the ARTG;
  • presentation of a product is in a form likely to result in its being confused with food, for example: in confectionery-like novelty shapes and packaging;
  • product names are used that are likely to be misleading as to the composition of the medicine;
  • the dosage form or directions are inappropriate for the target population, for example: a capsule dosage form is not appropriate for infants;
  • warning or cautionary statements needed for proper usage of the product are omitted;
  • claims are made that a formulation is 'hypo-allergenic' or 'non-irritant', unless the sponsor holds supportive evidence from clinical tests that can be produced on request;
  • claims are made that a product is free from certain substances, for example: 'free from artificial colours' if not true.

For a detailed outline of many of the considerations for the presentation of medicines, sponsors should refer to Complementary medicine presentation in the ARGCM. Some considerations for assessed listed medicines are addressed below.

7.2 Name

The name of an assessed listed product refers to the identifying descriptor given to the product by the sponsor. This includes a proprietary name; non-proprietary name (e.g. Co-enzyme Q10 100 mg capsules); unique words or codes given to the product; any registered trade mark or other name, mark or logo that uniquely identifies the product; any distinctive colour or label presentation; and generic name (e.g. 'Acme Pharmaceuticals Vitamin C Tablets').

Assessed listed medicine applications will not be approved if, for example:

  • the name of a proposed assessed listed product might be misleading as to the composition of the medicine (refer to Unacceptable presentation);
  • the name (and any other information on the label) breach the Therapeutic Goods Advertising Code;
  • the use of a well-known brand name on new products ('umbrella branding') with different active ingredients relative to existing products, for either the same or a different indication, might cause consumers or health care practitioners to confuse existing and new products.

In instances where a brand name may be acceptable, the name of the new product is assessed based on the extent to which it will be immediately apparent to consumers that they are dealing with a different product. The strength of association of the brand name with the active substance or therapeutic use; the level of differentiation of the presentation of new product relative to current products; and the safety and efficacy in instances where consumers might mistakenly take the wrong product are all considered.

For further guidance, refer to:

7.3 Labels

A label, in relation to therapeutic goods, is a display of printed information on or attached to the medicine; on or attached to a container or primary pack in which the medicine is supplied; or supplied with the container or pack.

Medicine labels should comply with all relevant legislation before the medicine can be supplied in Australia, including advertising requirements. Specific documents relating to medicine labelling requirements include:

Copies of all draft medicine labels must be submitted with all applications to list new medicines and applications to change the labelling of an assessed listed medicine. A certified English translation of any other language appearing on the label must be provided. All text must be consistent with the English information and not include or imply any additional indications.

During the evaluation, all aspects of the medicine presentation, including proposed labelling and package inserts (if present), are assessed for compliance with the various legislative requirements (including advertising requirements). Some points of particular note are outlined below.

7.3.1 Listing number

Once approved, assessed listed medicines are assigned a unique AUST L(A) number which must be displayed on the label in accordance with the requirements of the Therapeutic Goods Labelling Orders and the Therapeutic Goods Regulations 1990.

7.3.2 Ingredients

The Therapeutic Goods Labelling Order specifies how ingredients should be declared on labels, and specifies the disclosure of certain excipients.

An excipient ingredient need not be nominated on a medicine label, unless it is a restricted ingredient (i.e. subject to a quantity or concentration based restriction referred to in a legislative instrument, such as the Therapeutic Goods (Permissible Ingredients) Determination). Where a sponsor chooses to disclose a (non-mandatory) excipient on a medicine label, then all excipients must be disclosed – i.e. declaration of excipients on a medicine label cannot be selective.

Statements such as 'gluten free' or 'sugar free' must be true of all ingredients in the medicine, including proprietary ingredients. The sponsor should provide written assurance in their submission that the product does not include the stated substance.

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 and the Therapeutic Goods (Permissible Ingredients) Determination.

Claims relating to excipients will be assessed by the TGA during the evaluation.

In order to comply with their statutory obligations, sponsors are required to have evidence that their products do not contain undeclared declarable excipients, and do not contain ingredients they are claimed to not contain. This includes components of proprietary ingredients.

7.3.3 Directions for use

Directions for use of assessed listed medicines include the following information for each target population for which the product is intended:

  • dosage
  • method of administration
  • frequency and duration of treatment for each indication
  • relevant target population (e.g. age), where applicable.

For liquid products, recommended doses should be able to be measured using commonly available metric measures, or a suitable measure provided in the pack. References to a culinary 'spoonful' (e.g. teaspoon, dessertspoon, tablespoon, etc.) are not acceptable.

Products which are intended for symptomatic relief 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.

A statement regarding 'duration of use' should be included on the label.

7.3.4 Claims

Claims that do not include a specific therapeutic use of the medicine (e.g. 'contains 30% more', 'water resistant' etc.) are not considered to be indications. Such claims are not required to be in the ARTG entry for a medicine.

However, the medicine label must not include any claim that is inconsistent with the information included in the ARTG for the medicine, and must comply with applicable standards and advertising requirements outlined in Complementary medicine presentation and the Therapeutics Goods Advertising Code.

Label flashes such as 'New Formulation' or 'Now with ...' should not be used to describe any product, presentation, indication or claim which has been available and promoted in Australia for more than 12 months.

The product labels and all claims are pre-market assessed by the TGA. Sponsors of assessed listed medicines must therefore provide evidence at the time of application to support all claims for the formulated product. Some types of claims have specific requirements, as outlined below.

Claim that product has undergone efficacy assessment

As part of the Government's complementary medicine's reforms, the TGA is considering a 'claimer' to allow assessed listed medicines to claim that the product has undergone efficacy assessment. The TGA is refining options for the claimer after receiving comments from consumers and industry during the public consultation process.

Claims implying a high level of certainty

Claims that may lead consumers to believe that the evidence supporting the efficacy of a product is unequivocal are not appropriate unless supported by sound data from robust clinical trials on the product. This includes graphics or flashes using text such as 'clinically' and 'scientifically' in combination with 'proven', 'tested', 'trialled' etc.

Claims of rapid effect

Claims of 'fast' or 'rapid' action or effect may be used when the indications are for relief of symptoms where the speed of onset is relevant and they are well supported by clinical and pharmacokinetic data. They are not suitable when used in relation to chronic conditions, conditions not requiring immediate relief, or medicines where the pharmacokinetics or mechanism of action precludes a fast action. For further information, refer to Guidelines on presentation aspects of OTC applications.

7.3.5 Warning and disclosure statements

Product labels must include the advisory statements required by the Therapeutic Goods (Permissible Ingredients) Determination and Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). These legislative instruments work in conjunction to regulate ingredients included in all listed medicines, as described in Item 3 of Schedule 4 to the Therapeutic Goods Regulations 1990. As a result, if a requirement is included in the SUSMP, it applies to listed medicines, even if that requirement is not expressly stated in Therapeutic Goods (Permissible Ingredients) Determination.

All indications relating to symptoms must be accompanied by the statement 'If symptoms persist consult your healthcare practitioner' or words to that effect.

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 list or vary a product.

7.3.6 Comparisons, endorsements and sponsorships

Statements comparing a product with other products or treatments must be supported by acceptable evidence, and must comply with the Therapeutic Goods Advertising Code.

Labels must not contain or imply endorsement of the product, except as permitted by the Advertising Code. Once an endorsement is no longer applicable, the sponsor must remove the endorsement via a notification to the TGA.

Labels may include reference to sponsorship of the product when in compliance with the 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, a request for approval of the restricted representation must be included in the medicine application.

7.3.7 References to internet sites or other products

The inclusion of internet addresses on labelling is only acceptable where the information on the website (including any direct links from that website) is consistent with the information included in the ARTG for that product. Websites are considered advertising and are subject to the Therapeutic Goods Advertising Code.

References to a sponsor's other products may be permitted, provided that the products are included in the ARTG and have been pre-market assessed for efficacy. This includes situations where reference is made to:

  • more suitable dosage forms within the same range for different age groups
  • another product that can be used in conjunction with the product, where appropriate
  • other products within the same product range that have the same trade name as the current product, where appropriate.

7.3.8 Graphics, logos, symbols and market differentiations

Non-corporate graphics, logos or symbols on labels must be consistent with the product's approved details, including being appropriate for the claimed therapeutic use of the product. For example, a graphic highlighting joints would be inappropriate for a product that is indicated for use only on soft tissues.

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 (see Unacceptable presentation).

7.4 Advertising

Non-corporate graphics, logos or symbols on labels must be consistent with the product's approved details, including being appropriate for the claimed therapeutic use of the product. For example, a graphic highlighting joints would be inappropriate for a product that is indicated for use only on soft tissues.

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 (see Unacceptable presentation).

7.4.1 Restricted representations

It is both an offence under the Act (see paragraph 42DL(1)(c)) and a breach of the Therapeutic Goods Advertising Code for a sponsor to refer to a restricted representation without prior approval of the Secretary of the Department of Health.

To obtain approval for the use of a restricted representation in relation to an assessed listed medicine, sponsors may submit a request under section 42DE of the Act at the time of application for the listing of the medicine. The 'Application for approval to use a restricted representation in advertising' on the TGA website should be included in the evidence package submitted to the TGA, and should be supported by scientific evidence appropriate for an intermediate level indication. The application must also provide a justification as to why the representation is necessary for the appropriate use of the medicine and how the public interest criteria will be applied (see Therapeutic Goods Advertising Code).

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