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ARGOM Appendix 3: Guidelines on presentation aspects of OTC applications

Version 1.0

12 October 2012

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2. Product name

Note: The TGA is initiating a review of the labelling and packaging regulatory framework for prescription medicines, over the counter medicines and complementary medicines. This section 'Product name' will be revised pending the outcomes of the labelling and packaging review.

2.1 Interpretation of 'name'

This section provides an interpretation of the meaning of 'name' as used in Schedule 16 of the Therapeutic Goods Regulations 1990 (the 'Regulations') and as applied to medicines. Under Schedule 16, goods are regarded as 'separate and distinct' if they differ from other goods in any of the following features:

  1. formulation, composition or design specification;
  2. strength or size (disregarding pack size);
  3. dosage form or model;
  4. name;
  5. indications;
  6. directions for use;
  7. different container type (disregarding container size).

The 'name' is regarded as including the following [terms used are as defined in the Therapeutic Goods Order No. 69 - General requirements for labels for medicines (the Labelling Order)]:

  • 'Proprietary name' (the registered trade mark of the medicine or the unique name assigned to the medicine by the Sponsor and appearing on a label); or if there is no proprietary name,
  • The 'Non-proprietary name' [the name used to describe the medicine in a specific standard. It includes the name of the dosage form (e.g. Paracetamol tablets BP). If no specific standard exists, a name comprising the name(s) of the active ingredient(s) and the name of the dosage form (e.g. Promethazine 25 mg tablets)]; and
  • Any unique word or code given to the product; and
  • Any registered trade mark or other name, mark or logo that uniquely identifies the product; and
  • Any distinctive colour or label presentation.

For products that are licensed with a 'generic' name (e.g. 'Cold Tablets' or 'Paracetamol Tablets'), the name of the Sponsor or distributor as it appears on the label (wherever it is located) is regarded as part of the 'name' of the product (e.g. a product labelled 'Cold Tablets' with the Sponsor identified on the label as 'Acme Pharmaceuticals' will be regarded as having the name 'Acme Pharmaceuticals Cold Tablets').

Products that have a different 'name' require a separate entry in the Australian Register of Therapeutic Goods (ARTG, the 'Register'). Retailers or marketing groups that wish to have products that are uniquely identified in the marketplace as their own will need to lodge separate applications to register or list these products.

2.2 'Umbrella'/Family brand names

'Umbrella' or 'family' branding describes the situation where a sponsor markets different products under the one brand name (e.g. Strepsils lozenges, Strepsils mouthwash, Strepsils Family Cough Medicine).

The use of a well-known brand name on new products with different active ingredients for either the same or a different indication could cause the consumer or health care practitioner to confuse the current products and the new product. In these circumstances, the 'presentation' of the product may be 'unacceptable' (see 'Section 1 Unacceptable presentation').

Where the brand name is strongly associated with a particular active and there are significant differences in the safety, efficacy or dose regimen of the current and proposed products, the new product will not be accepted under the proposed trade name.

In cases where the brand name is not strongly associated with a particular active or combination of actives and there are no significant differences in the safety, efficacy or dose regimen of the current and proposed products, the potential for confusion may be able to be addressed by clear differentiation of the packaging and labelling of the new product to the extent that it will be immediately apparent to consumers that they are dealing with a different product. In some cases this may require modification of the labels of the new product and all products in the existing range to include the name of the active ingredient as part of the product name using the same font style and size.

In assessing whether the use of an existing brand name for a new product with different active ingredients is acceptable, the following points are considered:

  1. Association
    The strength of association of the brand name with a particular active substance and/or therapeutic use:
    • history of marketing and advertising;
    • the extent of prescribing by medical practitioners and recommendation by pharmacists [including whether the brand is or has been listed on the Pharmaceutical Benefits Scheme (PBS)];
    • the number and proportion of products within the brand range with a particular active substance;
    • the presence of products within the brand range that have a different active substance(s).
  2. Differentiation
    Whether the presentation of the new product is sufficiently different to the existing product range to alert consumers to the fact that this is a different product, despite the similarity in product name:
    • Wording (particularly the prominence of identification of the active ingredient) on the labels of proposed product and existing product(s);
    • Pack colour, shape, size, layout and design;
    • The dosage form: visual appearance, physical characteristics, smell and taste;
    • The likelihood that consumers will mistake the new product for the existing one at the point of sale and at the point of use (e.g. at a child's bedside in the middle of the night).
  3. Safety
    • Consider the consequences if a consumer took the new product as if it were the existing product and vice-versa.
    • Consider sub-groups for which there may be specific safety concerns, for example Consumer's with gastric ulcer or asthma if the products are confused.
    • Consider the conditions the new product and existing products are intended to treat. If the conditions are different (e.g. the existing products are all antifungal and the new product is an antiviral), are there any safety concerns if a consumer confuses the products?
  4. Efficacy
    • Consider the consequences if a consumer took the new product as if it were the existing product and vice-versa.
    • If the dose is different (amount, frequency or duration) or if the conditions to be treated by the existing and new products are different, are there any efficacy concerns if the consumer confuses the new and existing products?
  5. Other information
    • The classification of the product - is professional advice available / required at the point of sale?
    • The sponsor's proposals for advertising / consumer education / practitioner education.
    • Evidence of consumer testing to demonstrate adequate differentiation between the products.

2.3 'Own name' products

'Own name' products are those that are identified on the label as being associated with a particular retailer or marketing group. 'Own name' OTC products can be supplied under two alternative arrangements:

  1. Separate registration/listing
    Where a sponsor or retailer wants to label a product with a name that is unique to a particular retailer (e.g. 'Carter's Cold Tablets') a separate entry is required in the ARTG and the product will carry an Australian Registration/Listed number (AUST R/L) unique to that product.
  2. Use of an existing registered/listed product
    Under this arrangement some retailer identification may be included on the label of an existing registered/listed OTC product without requiring a separate entry in the ARTG. The product will continue to be registered in the ARTG by the original sponsor and carry the product's AUST R number.

In these instances, the product can be labelled with either or both of the following:

  • On the main label, identifying details of the retailer in a font size not larger than that used for the active ingredients preceded by the words "sold by" or "made for" or "manufactured for" or "distributed by";
  • On another part of the product (e.g. on the back label), identifying details of the retailer in a font size not larger than that used for the product name preceded by the words "sold by" or "made for" or "manufactured for" or "distributed by".

2.4 Professional endorsement

Pharmacists, pharmacy marketing groups, hospitals or other health professionals may wish to register or list products under their own name (e.g. 'Carter's Cold tablets' as above). Care needs to be taken to ensure that the name of the product, and any other information on the label, does not breach the 'professional endorsement' provisions of the Therapeutic Goods Advertising Code (a label is an 'advertisement' as defined in Section 3 of the Act).

The Code requires that advertisements must not contain or imply endorsement by 'individual healthcare professionals', other than where the emphasis is on 'availability' or by 'hospitals and other facilities providing healthcare services'.

Certain medicines are usually only available through pharmacies [those included in Schedules 2 and 3 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP or Poisons Standard)]. These medicines must include the signal heading "Pharmacy Medicine" or "Pharmacist Only Medicine". These signal headings do not breach the Code because they describe the availability of the product - that is you must visit a pharmacy to purchase products in either category but must consult the pharmacist to purchase a 'Pharmacist Only Medicine' product.

Where names of products are proposed that include references to pharmacy or pharmacists or other healthcare professionals, it needs to be considered whether the reference is to 'availability' or whether it constitutes 'endorsement' by the pharmacist or by the 'facility providing healthcare services' (e.g. the pharmacy).

For instance, the words "Pharmacy formula" or "Pharmacy Only" would not be taken to breach the Code because they are a reference to 'availability'. This interpretation only applies where a product is sold exclusively in pharmacies. If, for example, a paracetamol product bearing the name "Pharmacy formula" were to be sold in a supermarket, the reference to "pharmacy" could be interpreted as an endorsement by the pharmacy profession and would therefore be in breach of the Code.

Where a pharmacy marketing group has a name that clearly implies professional recommendation (e.g. "Pharmacist Advice"), the name and/or logo of the marketing group can only appear on product labels where it can be established that this name/logo is strongly linked with the point of supply. This could be the case in the following circumstances:

  • Pharmacies subscribing to the marketing group are required to be identified with the name of the marketing group; and
  • The products are not available to retail outlets that are not members of the marketing group; and
  • The name/logo of the marketing group appears on the label in close proximity to the product's name; or
  • The name/logo of the marketing group appears elsewhere on the label and is a registered trade mark of the marketing group.

Where the above does not apply and the sponsor's name implies professional recommendation, that name cannot be used as part of the product name but can be included in small font, not on the main label, as part of the sponsor's name and address as required by the Therapeutic Goods Order No. 69 (TGO 69) - General requirements for labels for medicines, without breaching the Code.

Products that have names that breach the professional recommendation provisions of the Therapeutic Goods Advertising Code will not be approved. Names that have been accepted to date include 'Chemists' Own', 'XX Chemists', 'Health Care Chemist', 'XXX Pharmacy', 'Pharmacist', 'Pharmacist Formula', 'Pharmacy Formula', 'Pharmacy Health' and 'Pharmacist Advice'.

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