Allens

Biotech & Health

Focus: TGA review on packaging and labelling

7 June 2012

In brief: The Therapeutic Goods Administration has recently released the latest consultation paper in its review of packaging and labelling of medicines in Australia, which, on completion, is expected to have a significant impact on the pharmaceutical industry. Partner Richard Hamer (view CV) and Lawyer Ali Ridley report.

How does it affect you?

If adopted, the recommendations would mean:

  • Active ingredients will be required to be listed on at least three sides of the packaging, with the active ingredient having the same prominence as the brand name.
  • Sponsors of new medicines will be required to submit evidence of risk assessment of proposed labelling or packaging.
  • New and existing medicines with a similar brand name to an existing product will be required to differentiate their product's packaging.
  • Identical products will no longer be able to be marketed separately for a range of symptoms.
  • Packaging for over-the-counter and complementary medicines will need to display a standardised information panel (the Medicine Information Box).

Background

In the paper, the Therapeutic Goods Administrations (the TGA) made a number of significant recommendations, in particular, regarding the display of active ingredients on medicine labels, the issue of look-alike and sound-alike names and packaging and the introduction of a standardised information format; and the Medicine Information Box. The paper also made recommendations regarding a number of other practical issues in relation to packaging and labelling.

The TGA has made few allowances for the commercial nature of the industry, with the reduced prominence of brand names expected to have considerable ramifications.

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Key recommendations

A brief summary of the key recommendations contained in the paper is set out below.

Active ingredients

The TGA has made a number of recommendations in regard to the active ingredient of medicines. In particular, the TGA has recommended that the active ingredient must be listed:

  • with equal prominence to the brand name;
  • on at least three non-opposing faces of a carton, including the main panel; and
  • immediately below the brand name.

In addition, the TGA have recommended that, for non-prescription products containing paracetamol or ibuprofen, a warning must now be placed on the front of the packaging, setting out the amount of paracetamol or ibuprofen contained in the medicine and a warning that a doctor or pharmacist should be consulted before taking other similar medicines. The size and presentation of this warning has been fixed by the TGA.

These recommendations have been introduced in an attempt to prevent consumers accidently taking double doses of an active ingredient due to confusion over ingredients. In particular, in the case of paracetamol and ibuprofen, the TGA has identified that consumers may use a medicine containing the same ingredient, such as a cold and flu tablet and cough medicine, without realising that both contain paracetamol. This situation places the consumer at risk of an overdose, a scenario that the TGA hopes will be prevented by the advent of more prominent advertising of the active ingredient.

Look-alike, sound-alike

Look-alike sound-alike names and look-alike packaging are recognised by the TGA as an ongoing issue. The TGA is aware of a number of cases where pharmacists and consumers have confused products with similar names or packaging, meaning that consumers have been provided with medicine that is ineffective or even dangerous. In an effort to combat this, the TGA made a number of recommendations, in particular:

  • sponsors of new medicines will now be required to submit evidence of risk assessment of proposed labelling or packaging;
  • new medicines with a brand name that differs from another product in the Australian Register of Therapeutic Goods by three letters or fewer must use colours and designs that contrast it with the existing product. Sponsors of existing medicines that wish to change packaging must also comply with this recommendation;
  • products with the same quantity of active ingredient cannot be selectively differentiated or marketed for a specific subset of symptoms (eg headaches or joint pain); and
  • the same brand name cannot be applied to products that have different active ingredients unless those active ingredients are closely related and the safety profile, efficacy and dosage regime are similar.
Medicine Information Box

In an effort to standardise the format and type of information found on medicine packaging, the TGA has recommended the introduction of a Medicine Information Box for over-the-counter and complementary medicines. Medicine Information Boxes will contain mandatory headings covering active ingredients, uses, warning and allergy information, directions and storage information. For smaller, or unusually shaped packaging, different requirements apply.

Other recommendations

The TGA has also made a number of other recommendations in relation to blister strip labelling, pack inserts and space for dispensing labels.

In order to implement the changes recommended, the TGA also plans to set up a Labels and Packaging Advisory Committee.

Interested parties have the opportunity to make submissions to the TGA regarding the recommendations outlined in the consultation paper. Submissions must be received by 24 August 2012.

For further information, please contact:

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