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ARTICLE · 24 JANUARY 2017

Liquidators and the TGA – legislative and practical issues

The main concern for external administrators of therapeutic goods companies is potential exposure to personal liability.

AustraliaInsolvency/Bankruptcy/Re-Structuring

Liquidators can face significant issues when appointed over companies that operate under the licencing regime of the Therapeutic Goods Administration (TGA).

The TGA is a Commonwealth Government agency administered by the Department of Health. It's responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods – which can range from biological products (like stem cells and cord blood) to medical devices (such as blood pressure monitors and MRI scanners).1 It also issues licences to companies that handle therapeutic goods.

The TGA operates in accordance with the Therapeutic Goods Act 1989 (Cth) (the Act) and the accompanying Therapeutic Goods Regulations 1990 (Cth) (the Regulations). The Act provides for controls relating to the quality, safety, efficacy and availability of therapeutic goods produced or used with Australia.2

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