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Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

Chapter 5A of the Therapeutic Goods Act 1989 contains the enforcement provisions that allows the Therapeutic Goods Authority (TGA) to:

  • commence civil proceedings (Section 42Y) or criminal proceedings (Section 42YH);
  • seek injunctions (Part 5A-4);
  • issue infringement notices (Part 5A-2); or
  • accept enforceable undertakings (Section 42YL). 

The TGA also has administrative powers for entry, searches and warrants (Part 6-2 of the Therapeutic Goods Act).

Executive officers of a body corporate may also be held personally liable for certain offences (Sections 54B and 54BA of the Therapeutic Goods Act).

Further, the TGA also has powers of suspension and cancellation of therapeutic goods and devices from the Australian Register of Therapeutic Goods. Sections 29D and 30 of the Therapeutic Goods Act outline the circumstances where the secretary may suspend or cancel the registration or listing of therapeutic goods. Provisions relating to biologicals are included in Part 3-2A, Divisions 6 and 7 and those relating to medical devices are found in Chapter 4, Part 4-6 of the Therapeutic Goods Act..

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

Part 5-2 of the Therapeutic Goods Act sets out offences dealing with counterfeit therapeutic goods.

There is a penalty of seven years’ imprisonment or a fine of A$420,000, or both. An executive of a body corporate may also be personally liable under this section (Section 42E(1) of the Therapeutic Goods Act). Civil penalties also apply for an individual (A$1.05 million) or body corporate (A$10.5 million) (Section 42EA of the Therapeutic Goods Act).

Section 42EB of the Therapeutic Goods Act sets out circumstances where there may be relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods.

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