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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.

Code of practice

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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.

Contents

  1. Preface
  2. Introduction
  3. Definitions
  4. Scope
  5. Requirements
  6. Tamper-evident features
  7. Validation of TEP
  8. Labelling
  9. Useful references
  • Appendix 1 - Example label statements

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Content last updated: Tuesday, 16 December 2008

Content last reviewed: Tuesday, 16 December 2008

Web page last updated: Monday, 8 August 2011

URL: http://www.tga.gov.au/industry/packaging-tamper-evident-cop.htm