Child-Resistant Packaging Requirements for Medicines - Australian Government

Description

You must comply with these requirements if you sponsor medicines of a level of toxicity that would be harmful if accidentally ingested by children.

Responsibility for compliance of these requirements rests upon sponsors of medicines unless the packaging manufacturer is also the sponsor of the medicine.

These requirements do not apply to medicine that is:

  • packaged in bulk for dispensing purposes only
  • intended to be administered by injection
  • individually wrapped powder
  • homeopathic preparations
  • not a final stage of manufacture
  • intended for use in a hospital, nursing home or dental surgery.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines 2008 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Enquiries

Therapeutic Goods Administration

Department of Health

Mailing address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)