Nicovations Australia Pty Ltd v Secretary of the Department of Health [2016] FCA 394

FEDERAL COURT OF AUSTRALIA

Nicovations Australia Pty Ltd v Secretary of the Department of Health [2016] FCA 394 File number: NSD 1274 of 2015

Judge: ROBERTSON J

Date of judgment: 21 April 2016

Catchwords: HEALTH LAW – Australian Register of Therapeutic Goods – application for registration of therapeutic goods, being a Voke Inhalator nicotine 0.43 mg pressurised inhalation aerosol can – Therapeutic Goods Act 1989 (Cth) s 23 – whether application made in accordance with a form approved by the Secretary – whether application effective – whether application made in accordance with s 23 for the purposes of s 25 of the Therapeutic Goods Act so that the Secretary must evaluate the goods for registration – whether letter of 16 October 2015 constituted or evidenced an "initial decision" within s 60 of the Therapeutic Goods Act ADMINISTRATIVE LAW – jurisdiction of the Federal Court of Australia under the Administrative Decisions (Judicial Review) Act 1977 (Cth) – whether letter of 16 October 2015 constituted a "decision" for the purposes of that Act – jurisdiction of the Federal Court of Australia under s 39B of the Judiciary Act 1903 (Cth) – officer of Therapeutic Goods Administration treating an application for registration of therapeutic goods as not being made in accordance with s 23 of the Therapeutic Goods Act because not made in accordance with a particular form approved by the Secretary – whether error so as to found a remedy under s 39B of the Judiciary Act or under the Administrative Decisions (Judicial Review) Act

Legislation: Acts Interpretation Act 1901 (Cth) ss 25C, 33 Administrative Appeals Tribunal Act 1975 (Cth) s 3(3) Administrative Decisions (Judicial Review) Act 1977 (Cth) ss 5, 6, 7 Federal Court of Australia Act 1976 (Cth) s 21 Therapeutic Goods Act 1989 (Cth) ss 23, 25, 31, 60 Poisons Standard 2015 (Cth) Sch 4 Therapeutic Goods Regulations 1990 (Cth) regs 16C, 16D, 16F, 16G, Sch 10 Pt 1 and Pt 3