Firm Description

Griffith Hack is Australia’s largest IP firm for Australian applicants, comprising patent and trade marks attorneys, IP lawyers, information services, and IP portfolio management consultants. We provide a full range of comprehensive IP services to many of Australia’s leading companies. In particular, our lawyers have significant experience in advising on the regulatory issues involved in many industries, including the pharmaceutical, medical devices and biotechnology industries, including in relation to:

• the operation and effect of the Australian Therapeutic Goods Act 1989, and associated regulations;
• the role of, operations and decisions of the Therapeutic Goods Administration (Australia’s equivalent body to the US FDA);
• the registration and approval processes for therapeutic goods and medical devices in Australia;
• clinical trial regulation in Australia, including clinical trial agreements and GCP compliance;
• the Commonwealth pharmaceutical reimbursement program, the PBS;
• genetically modified organism (GMO) regulation;
• biodiversity legislation;
• food standards and GM food labelling issues.

Many of the regulatory approval processes involved in these industries include the ability for administrative reviews of decisions made by regulatory bodies. We have advised and acted for several entities seeking to challenge decisions made by regulatory bodies, including seeking information on decisions (through FOI applications), internal administrative reviews and the institution of Federal Court proceedings under the Commonwealth Administrative Decisions (Judicial Review) Act.