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