Our team has extensive experience in guiding clients through the regulatory regimes. We assist them in moving products to market as quickly and cost effectively as possible and ensuring ongoing compliance after market-entry.
We advise on all aspects of regulatory approval processes including obtaining marketing approval for, and clinical testing of, a wide range of goods and devices. We also advise on issues such as pharmaceutical products on the Pharmaceutical Benefits Scheme and cost sharing arrangements with the Australian Government. Throughout these processes, our lawyers frequently negotiate with and have established relationships with key contacts at bodies such as the Therapeutic Goods Administration, the Pharmaceutical Benefits Advisory Committee and the Department of Health & Ageing.
Our team have extensive experience in advising on product labelling, advertising and promotion in advertising disputes involving the Therapeutic Goods Advertising Code, the Medicines Australia Code of Conduct and the ASMI Code of Conduct as well as claims under the Trade Practices Act and Fair Trading Acts.
We advise clients on issues concerning their interaction with patients and healthcare professionals including the design and administration of compassionate use programs, patient familiarisation programs, sponsorship opportunities and market research activities.
We assist clients with all aspects of administrative law arising from the regulatory framework governing the life sciences sector. This includes making and resisting freedom of information requests, identifying issues capable of administrative and judicial review and representing clients in the review process. Our lawyers have extensive experience of challenging decisions of the Therapeutic Goods Administration about including goods on the Australian Register of Therapeutic Goods. Our team have challenged determinations of the Pharmaceutical Benefits Advisory Committee concerning issues such as including goods on the PBS and applying policies such as reference pricing and price reduction to goods on the PBS.
“This pre-eminent practice is credited with housing some superb talent.”
Chambers Global Guide 2006-2007