Code of Practice for Tamper-Evident Packaging of Therapeutic Goods – TGA Guidelines

Purpose and Scope

The Code of Practice aims to minimise risks from tampering, substitution, or adulteration of therapeutic goods supplied in Australia. It applies to all therapeutic goods including:

• Medicines (prescription, OTC, complementary)
• Medical devices
• Biologicals
• Therapeutic goods in general

Tamper-evident packaging provides visible or functional evidence that the package has been interfered with.

Key Requirements

• Mandatory tamper-evidence: All consumer packs of therapeutic goods must incorporate tamper-evident features.
• Features must be effective: The tamper-evident mechanism should be difficult to duplicate and clearly indicate tampering.
• Placement: Tamper-evident features must protect primary access points (e.g., closures, seals on bottles, blister packs).

Acceptable Tamper-Evident Features

Common acceptable methods include:

• Breakable or frangible seals/stickers over closures.
• Shrink or stretch bands around closures and necks.
• Sealed or taped cartons/boxes.
• Blister or strip packs that show individual dose removal.
• Induction seals or foil seals under caps.
• Tear-away or perforated features.
• Printed instructions warning if seal is broken.

Exclusions and Special Cases

• Professional-use-only packs (e.g., hospital supplies) may have reduced requirements.
• Certain sterile devices or large-volume goods may use alternative controls.
• Custom-made or extemporaneously compounded goods are exempt.

Responsibilities

• Sponsors/manufacturers: Ensure packaging complies before supply.
• Importers: Verify compliance for imported goods.
• Retailers: Must not supply non-compliant products.

Compliance and Enforcement

• Non-compliance may result in product recalls, cancellation from ARTG, or penalties.
• TGA may require evidence of compliance during audits or investigations.
• Sponsors should document tamper-evident design in technical files or risk assessments.

Detailed definitions of tamper-evident features, examples of acceptable and unacceptable methods, risk considerations for different product types, labelling statements, transition arrangements, and compliance checklists are provided in the TGA Code of Practice for tamper-evident packaging of therapeutic goods. Source: Code of practice for tamper-evident packaging of therapeutic goods - TGA

This code helps safeguard public health by making tampering more detectable and deterring malicious interference with therapeutic products in Australia.