Australia: Pharmaceutical ingredient names - the difference a letter can make

Further Changes to Labelling and Packaging for Pharmaceutical Businesses Harmonisation of Ingredient Names by the TGA

INNs

In an effort to avoid confusion, the World Health Organisation designates a generic name, or International Non-proprietary Name (INN), for each ingredient in medicines. Pharmaceutical companies then use proprietary names, or trade marks, to distinguish their goods from those of other traders. An example of this is the INN 'paracetamol' which is also known by proprietary names such as Panadol in Australia, or Tylenol in the US.

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 Organisation'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 15 May 2013 that it will undertake a process of harmonisation of ingredient names. The changes do not impact herbal ingredients, ingredients in medical devices, biologicals and, importantly, trade names.

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 harmonisation 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 labelling 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 recognisable to the industry as the known 'American' 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, labelling, Product Information documents and Consumer Medicines Information leaflets. In relation to packaging, the TGA has proposed that sponsors update their labels and packaging within two 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.

What does this mean for you?

This could mean that some businesses, (especially those who 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 standardisation 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.

Submissions on the harmonisation of ingredient names can be made to the TGA until 10 July 2013. Norton Rose would be happy to assist you with a submission or further advise you on how the proposed changes will impact your business and your products.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.