In an effort to avoid confusion, the World Health Organization designates a generic name, or International Non-proprietary Name (INN), for each ingredient in medicines. Pharmaceutical companies may then use proprietary names, or trade marks, to distinguish their goods from those of other traders. An example of this is the INN ingredient ‘paracetamol’ which is also known by proprietary names such as Panadol in Australia, or Tylenol in the US.[1] In Australia, the formulation of a product must be supplied to the Therapeutic Goods Administration (TGA) during the process of registration or listing as a therapeutic good. The TGA maintains a database of approved ingredient names to be used for this purpose. Only from 2002 onwards, has the TGA adopted the World Health Organization’s INN terminology for new medicines ingredients. This has resulted in some ingredients added to the TGA’s database prior to 2002 retaining names inconsistent with INN terminology. The TGA has indicated that 472 ingredients have names inconsistent with INN terminology.

Proposed changes

To address this issue, the TGA announced on May 15, 2013 that it will undertake a process of harmonization of ingredient names. The changes do not impact herbal ingredients, ingredients in medical devices, biologicals and, importantly, trade names. Find the TGA Consultation Paper here.

While some of the changes are relatively minor, and in many ingredients involve a change to only one letter (for example a change from PH to F, or Y to I), the process of harmonization will still have a major impact of pharmaceutical businesses. For example, the common antibiotic ingredient ‘amoxycillin’ will be changed to ‘amoxicillin’ to reflect the INN. However, some changes are more significant and will have a real impact on labeling and space, for example the ingredient ‘glucose’ will be changed to ‘glucose monohydrate.’ Many of the changes, such as the change from ‘adrenaline’ to ‘epinephrine’ will be recognizable to the industry as consistent with known ‘American’ (i.e. USAN) names. The TGA is seeking comments and feedback on the proposed changes to ingredient names and the associated transitional provisions for their implementation on packaging, labeling, Product Information documents and Consumer Medicines Information leaflets. In relation to packaging, the TGA has proposed that sponsors update their labels and packaging within 2 years of the TGA’s ingredients database being updated, or at the next print run, or packaging artwork amendment, if this occurs within 2 years. It is proposed that the updates will occur in 2014. Find the TGA Consultation: International harmonization of ingredient names here. The consultation closes to comments on July 10, 2013.

What does this mean for you?

This development could mean that some businesses, (especially those which sell over-the-counter or homeopathic health products) will need to be prepared to make changes shortly after the updates as the requirements may be triggered by a promotional campaign that uses advertising on the packaging to support the point of sale materials. Arguably, international companies may benefit from increased standardization of ingredient names across their packaging, despite an increase in costs initially. With the TGA’s medicine labeling and packaging review still under way (for more information, see our article dated 29 November 2012) pharmaceutical businesses will still need to co-ordinate a number of changes to their packaging and branding. If the TGA adopts its proposed labeling and packaging changes, Australian products will need to comply with different requirements regardless. We note that to date the TGA has not released any further information on the progress of the review since the initial analysis of submissions was released in January this year Sources: World Health Organization; Therapeutic Goods Administration (Australia)

This article was prepared by Frances Drummond (frances.drummond@nortonrosefulbright.com / +61 2 9330 8007) and Emma Bekens (emma.bekens@nortonrosefulbright.com / +61 2 9330 8943) of Norton Rose Fulbright Australia. [1] In the United States, paracetamol is most often known by its USAN name, acetaminophen. The United States Adopted Name (USAN) Council is responsible for assigning non-proprietary names in the U.S. and works closely with the WHO to achieve consistency in naming. As the paracetamol example shows, harmony is not always achieved.