Australian company pays fine for illegal medicine exports

On 14 December 2018, the Therapeutic Goods Administration (TGA) issued Australian company, TK Imports Wholesale Pty Ltd, an infringement notice. It is alleged that TK Imports Wholesale Pty Ltd exported unlawful medicines from Australia. These medicines were not included on the Australian Register of Therapeutic Goods (ARTG) or subject to approvals, exemptions or permits. They were also found to contain undisclosed ingredients.

Background

This investigation was initiated after Medsafe, New Zealand's regulator of medicines and medical devices, identified the goods were allegedly exported by an Australian identity. The exported goods were detected and detained by New Zealand Customs Service and the matter referred to Medsafe who conducted laboratory analysis of the seized goods. These tests identified a number of undeclared Schedule 4 (prescription-only) substances. Medsafe referred the matter to the TGA Regulatory Intelligence and Investigations Section (RIIS).

Enquiries made by RIIS confirmed that the alleged exporter was a repeat offender that had knowledge of the therapeutic goods regulatory scheme through previous dealings with the TGA.

Current status

TK Imports Wholesale Pty Ltd paid the infringement notice in full on 1 February 2019. The investigation is now closed.

Legislation

Australia's therapeutic goods legislation prohibits the import, export, manufacture and supply of therapeutic goods for human use that are not included in the Australian Register of Therapeutic Goods (ARTG) or otherwise the subject of an exemption, approval or authority. Non-compliance with the legislation may result in court action, including the seizure and forfeiture of goods, heavy fines and/or terms of imprisonment.

The infringement notice was issued based on the alleged contravention of section 19B(4A) of the Therapeutic Goods Act 1989 (Cth). This is known as a 'strict liability' offence, which means only the physical element of the offence must be proven. The physical element in relation to this allegation is the act of exportation from Australia to another country.

There is no requirement with 'strict liability' offences to prove the fault element, which is the intent/knowledge i.e. the criminal mind.

The TGA works hand-in-hand with other authorities

The TGA continues to work with other authorities such as Australian Border Force and Medsafe to stop illegal import and export of therapeutic goods.

Consumers are urged to be aware that unapproved, illegal medicines may be counterfeit and include undisclosed and dangerous ingredients. Counterfeit medicines are becoming increasingly believable and difficult to distinguish from genuine, approved products. The TGA recommends that you seek advice from a health professional before taking a new medicine, and avoid purchasing therapeutic goods online, as the risk of receiving unapproved and/or counterfeit medicines is significantly higher.

Medicines that have been through the TGA's regulatory processed will have an AUST-R, AUST-L or AUST-L (A) number on the front of the packaging. You can also search the Australian Register of Therapeutic Goods (ARTG) to be certain.