Tamper-evident packaging
Tamper-evident packaging of therapeutic goods that may be vulnerable to tampering (either deliberate or accidental) is important in ensuring consumer safety and the integrity of the goods. Tamper-evident packaging increases the likelihood that consumers will recognise products that have been tampered with.
The Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Edition 1) was published by the TGA in June 2003 on behalf of the Industry Government Crisis Management Committee (IGCMC). The Code of Practice was developed under the direction of the IGCMC by its Subcommittee on Tamper-Evident Packaging, and is based on the earlier Guideline for the Tamper-Evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices, adopted on a voluntary basis by industry associations in December 2000.
- Code of practice for the tamper-evident packaging (TEP) of therapeutic goods (Edition 1, June 2003) (pdf,170kb)
- Guideline for the tamper-evident packaging of medicines, complementary healthcare products and medical devices, Edition 1 (22 December 2000) (superseded by the Code of Practice) (pdf,60kb)
The Code of Practice was developed to reflect world's best practice in the TEP of therapeutic goods, with the intention that it be regularly reviewed and amended as appropriate to accommodate packaging innovations and new information on packaging performance.
The Therapeutic Goods Committee has recommended that the Code of Practice be adopted as a mandatory packaging standard in Australia through the making of an order under section 10 of the Therapeutic Goods Act 1989.
The TGA has accepted this recommendation and is committed to the introduction of mandatory requirements for tamper-evident packaging for those kinds of therapeutic goods which potentially may become the target of tampering. However in view of the formation of the Australia New Zealand Therapeutic Products Authority (ANZTPA), some work remains to be completed in relation to the legislative underpinning of the Code of Practice. Until this occurs, the therapeutic goods industry is encouraged to continue to comply with the Code of Practice on a voluntary basis in anticipation of it becoming a mandatory standard.
Therapeutic Goods Order No. 71 Tamper-Evident Packaging (TEP) of Therapeutic Goods (TGO 71) seeks to adopt the document Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (Edition 1, June 2003) as a mandatory packaging standard for therapeutic goods in Australia.
A draft of TGO 71 has been prepared in accordance with the recommendation of the Therapeutic Goods Committee that the Code of Practice be adopted as a standard through an Order made under section 10 of the Therapeutic Goods Act 1989.
DRAFT Therapeutic Goods Order No. 71 Tamper-Evident Packaging of Therapeutic Goods (pdf,20kb)
Legislative underpinning of tamper-evident packaging requirements was foreshadowed in the industry guideline document Guideline for the Tamper-Evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices issued in December 2000, from which the Code of Practice was developed, and in the stakeholder consultation undertaken on the draft Code of Practice in May 2003. The TGA is continuing to work towards the gazettal of TGO 71.