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TGA medicine labelling and packaging review

Consultation

24 May 2012

Book pagination

Small containers

What is a small container?

Some medicines, such as those for injection, eye drops or medicines that are not to be taken for more than a few days, are supplied within small containers. This places obvious restrictions on how much information can be included on the primary packaging or medicine label. It would be impractical to request that manufacturers supply these medicines in larger packaging that would accommodate the required information.

Containers that have a nominal capacity of 20 millilitres or less are considered to be small containers.

What are the consumer health risks associated with small containers?

Given the size restrictions it is not possible to provide consumers and, in the case of injectable medicines, health care practitioners, with the information they need to support the quality use of the medicine on the label or primary packaging.

Pack inserts (documents that provide more detailed information than can fit on the medicine label) and primary packaging are important additions to small containers to ensure that important information is accessible. However, this additional information is only effective if the primary packaging and package insert is not discarded and always carried with the medicine. In particular in the case of eye drops, it is common for the small container to be carried without the primary packaging or the package insert. It is therefore critical that the small container contains the most important information that a consumer or health care practitioner needs.

Proposed regulatory changes

The following requirements are proposed for medicine containers with a nominal capacity of 20 millilitres or less:

7.1 These containers must be enclosed in a primary pack that fully complies with all labelling requirements and that includes a pack insert that provides detailed instructions for use.

7.2 The label on the container must include the following details in a letter height of not less than 1.5 millimetres:

  • The brand name of the medicine
  • The name(s) of all active ingredients in the medicine
  • For ophthalmic preparations the name of any antimicrobial preservatives in the medicine
  • Where there are more than three active ingredients, the three most abundant ingredients are to be included on the label of the container and the complete list of ingredients on the primary packaging and the pack insert
  • The batch number of the medicine
  • The expiry date of the medicine
  • If an injection, the approved route of administration
  • If an ophthalmic preparation for multidose use, a statement to the effect that the medicine should not be used later than four weeks after the container is first opened
  • If a solid ophthalmic medicine for preparing eye drops for multidose use, a statement to the effect that the medicine should not be used later than four weeks after the container is first opened

7.3 A clear space should also be provided to allow a pharmacist to affix a dispensing sticker. This space need not be the size of a standard dispensing sticker (80 x 40 mm), but should allow a folded sticker to be attached like a flag without obscuring information.

General question on the proposed regulatory changes for small container labelling

To what extent do you support the proposed changes for small container labels? Please provide details.

Do you have any further suggestions for how labelling of small containers could be improved?


Figures

Figure 11: Illustration of how information might be presented on an eye drop bottle

*Images shown are not actual medicines or brands.

A hypothetical small container illustrating the requirements under recommendation 7.2. The label also depicts an alternative presentation of information on a label as proposed under recommendation 4.6.

Front Hypothetical small container - front
Back Hypothetical small container - back
Left Hypothetical small container - left side

Figure 12: Illustration of how information may be presented on a small bottle of tablets

*Images shown are not actual medicines or brands.

A hypothetical small container illustrating the requirements under recommendation 7.2. The label also depicts an abridged medicine information box from recommendation 4.6, for use on a small container.

Front Hypothetical small container - front
Back Hypothetical small container - back
Left Hypothetical small container - left side
Left Hypothetical small container - left side

Book pagination