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

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

The assessment that Nicovations' application did not comply with s 23(1)(a) was legally erroneous. Nicovations applied on an approved over the counter medicine form on the basis that the Voke Inhalator was a Pt 3 Sch 10 product and not a Pt 1 product. The competing question whether that contention was ultimately correct, including whether the goods fell within the Sch 4 nicotine exception for oromucosal use, was a matter for evaluation under s 25 of the Therapeutic Goods Act, not a basis for refusing to treat the application as made in accordance with s 23. The 16 October 2015 letter was not an initial decision under s 60 because s 23 gave the Secretary no relevant decision-making power...

Jurisdiction
Australia
Judgment Date
21 April 2016
Procedural Posture
Application for Judicial Review Concerning an Application to Register Therapeutic Goods in the Australian Register of Therapeutic Goods / Final Judgment on the Application, Including an Application to Amend and the Respondents' Objection to Competency
Outcome
Application substantially allowed; respondents' objection to competency upheld; assessment that the application did not comply with s 23(1) set aside; respondents ordered to determine the application according to law; respondents to pay the applicant's costs.
Legal Topics
['australian Register of Therapeutic Goods' 'therapeutic Goods Act 1989 (cth) Ss 23, 25 and 60' 'approved Forms for Registration Applications' 'over the Counter Medicines and Prescription Only Medicines' 'administrative Decisions (judicial Review) Act 1977 (cth)' 'judiciary Act 1903 (cth) S 39 B' 'initial Decision and Review Rights']
['health Law' 'administrative Law'] ['australian Register of Therapeutic Goods' 'therapeutic Goods Act 1989 (cth) Ss 23, 25 and 60' 'approved Forms for Registration Applications' 'over the Counter Medicines and Prescription Only Medicines' 'administrative Decisions (judicial Review) Act 1977 (cth)' 'judiciary Act 1903 (cth) S 39 B' 'initial Decision and Review Rights']

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Procedural Posture

Application for Judicial Review Concerning an Application to Register Therapeutic Goods in the Australian Register of Therapeutic Goods / Final Judgment on the Application, Including an Application to Amend and the Respondents' Objection to Competency

Legal Issues

  1. 1 ["Whether Nicovations' application dated 29 June 2015 was made in accordance with s 23 of the Therapeutic Goods Act 1989 (Cth) where it used the approved form for over the counter medicines." 'Whether the Therapeutic Goods Administration could treat the application as non-compliant with s 23(1)(a) on the basis that the Voke Inhalator was considered a prescription only medicine requiring a different approved form.' 'Whether the question whether the Voke Inhalator fell within the exception for nicotine preparations for oromucosal use in Sch 4 to the Poisons Standard 2015 (Cth) should be decided at the s 23 application stage or at the s 25 evaluation stage.' 'Whether the letter dated 16 October 2015 constituted or evidenced an initial decision within s 60 of the Therapeutic Goods Act 1989 (Cth).' "Whether the respondents' objection to competency should be upheld in relation to the 24 September 2015 and 20 October 2015 letters and the conduct claim."]

Ratio Decidendi

The assessment that Nicovations' application did not comply with s 23(1)(a) was legally erroneous. Nicovations applied on an approved over the counter medicine form on the basis that the Voke Inhalator was a Pt 3 Sch 10 product and not a Pt 1 product. The competing question whether that contention was ultimately correct, including whether the goods fell within the Sch 4 nicotine exception for oromucosal use, was a matter for evaluation under s 25 of the Therapeutic Goods Act, not a basis for refusing to treat the application as made in accordance with s 23. The 16 October 2015 letter was not an initial decision under s 60 because s 23 gave the Secretary no relevant decision-making power...

Court Disposition

Application substantially allowed; respondents' objection to competency upheld; assessment that the application did not comply with s 23(1) set aside; respondents ordered to determine the application according to law; respondents to pay the applicant's costs.

Orders

  • ['The applicant have leave to amend its originating application for judicial review, in the form handed up by the applicant at the hearing on 31 March 2016, so as to add paragraph 5A to the claims for relief.' "The respondents' objection to competency dated 9 November 2015 be upheld." 'The second respondent be...