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Article: Therapeutic Goods Act 1989 - First Civil Penalties Case.
- Article from:
- Mondaq Business Briefing
- Article date:
- December 17, 2008
CopyrightCOPYRIGHT 2008 Mondaq Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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In the recent case of Secretary, Department of Health & Aging v Pagasa Australia Pty Limited, the Federal Court has for the first time considered the approach which should be taken in determining the civil penalties to be imposed under the Therapeutic Goods Act 1989 (Cth). The civil penalty provision was introduced into the Act in 2006 and at present the maximum civil penalty for an individual is $550,000 and for a body corporate $5,500,000. Factors which the Court will take into account include a party's co-operation once a contravention has been identified and the existence of an effective compliance program.
Civil penalties provisions can be found in a number ...