Tamper-evident packaging code of practice
16 December 2008
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.
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- Code of practice for the tamper-evident packaging (TEP) of therapeutic goods (Edition 1, June 2003) (pdf,468kb)
- Code of practice for the tamper-evident packaging (TEP) of therapeutic goods (Edition 1, June 2003) (Microsoft Word,6.28Mb)
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.
As the Code of Practice has not been reviewed since its publication in June 2003, it is currently under review by an expert Subcommittee of the Therapeutic Goods Committee (TGC) to ensure that it reflects current packaging technologies and stakeholder needs.
The therapeutic goods industry is encouraged to continue to comply with the Code of Practice on a voluntary basis while it is under review.
- Tamper-evident features
- Validation of TEP
- Useful references
- Appendix 1 - Example label statements
Content last updated: Tuesday, 16 December 2008
Content last reviewed: Tuesday, 16 December 2008
Web page last updated: Monday, 8 August 2011