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TGA medicine labelling and packaging review


24 May 2012

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Pack inserts

What is a pack insert?

A pack insert is a document that provides consumers with more detailed information about the medicine, such as more detailed directions for use than those provided on the medicine container or primary packaging. Not all medicines have a pack insert. Where a pack insert is included with the medicine, the medicine container or primary packaging notifies consumers of this.

Pack inserts are provided where the medicine is contained in a small container. Pack inserts are mandatory for injectable medicines.

What are the consumer health risks associated with pack inserts?

The key consumer health risks relate to access to information that allows them to use the medicines appropriately and safely. If pack inserts are used to compensate for information restrictions on small containers, it is important that the insert is concise and does not include extraneous information, such as advertising material.

There have been instances where the pack insert was printed on the inside of the primary packaging. The only way consumers could access this information was by cutting the primary packaging. In doing so, consumers lost access to mandatory information contained on the outside of the primary packaging

Proposed regulatory changes

8.1 Advertising material will not be permitted to be included as a separate pack insert or incorporated into an approved pack insert.

8.2 A pack insert must be in a form separate to the packaging; i.e. it cannot be printed on the inside of a carton.

General question on the proposed regulatory changes for pack insert requirements

Do you support the proposed changes for pack inserts? Why/why not?

Do you have any further suggestions regarding pack inserts?

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