Nicovations Australia Pty Ltd v Secretary of the Department of Health

AND: SECRETARY OF THE DEPARTMENT OF HEALTH First Respondent

GAELENE PYKE, PRINCIPAL EVALUATOR, OTC MEDICINES EVALUATION SECTION, THERAPEUTIC GOODS ADMINISTRATION Second Respondent

DR MAYADA KAYALI, DIRECTOR, OTC MEDICINES EVALUATION SECTION, THERAPEUTIC GOODS ADMINISTRATION Third Respondent

JUDGE: ROBERTSON J DATE OF ORDER: 21 APRIL 2016

1. 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.
2. The respondents' objection to competency dated 9 November 2015 be upheld.
3. The second respondent be removed as a party to the proceedings.
4. The assessment by the respondents made in or evidenced by the letter dated 16 October 2015 that the applicant's application dated 29 June 2015 did not comply with s 23(1) of the Therapeutic Goods Act 1989 (Cth) be set aside.
5. The respondents determine the applicant's application dated 29 June 2015 in accordance with law.
6. The respondents pay the applicant's costs, as agreed or assessed. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011

Introduction 1 This application for judicial review concerns an application by the applicant, to which I shall refer as Nicovations, to register goods being a VOKE INHALATOR nicotine 0.43 mg pressurised inhalation aerosol can (Voke Inhalator) in the Australian Register of Therapeutic Goods under the provisions of the Therapeutic Goods Act 1989 (Cth). The application was dated 29 June 2015. 2 The application to register was made in the form approved for the registration of over the counter medicines; was submitted electronically via the TGA eBusiness Services website; and was accompanied by the prescribed application fee. 3 After earlier correspondence between the parties, by letter dated 16 October 2015 it was stated that the Therapeutic Goods Administration was of the view that the material lodged by Nicovations did not comply with the requirements under s 23(1)(a) of the Therapeutic Goods Act because it was not in accordance with a form approved under that provision for applications relating to a medicine of a kind specified in Pt 1 of Sch 10 of the Therapeutic Goods Regulations 1990 (Cth). The 16 October 2015 letter stated that the Therapeutic Goods Administration was of the view that the Voke Inhalator would be considered a prescription only medicine because it contained nicotine of the kind listed in Sch 4 of the Poisons Standard. That letter was signed by the Director, OTC Medicines Evaluation, Complimentary and OTC Medicines Branch: Dr Mayada Kayali. OTC refers to over the counter. 4 Put generally, the applicant did not use the approved form for a prescription only medicine. The applicant used the form for an over the counter medicine, its contention being that the Voke Inhalator was such a medicine. 5 The ultimate question between the parties is whether the Voke Inhalator is within the exception in the definition of "nicotine" in Sch 4 to the Poisons Standard 2015 (Cth) for use as an aid in withdrawal from tobacco smoking in preparations for oromucosal use, as defined. But the applicant's primary issue before the Court is whether that ultimate question is to be decided by reference to compliance of the application with another, different, form approved by the Secretary for the purposes of s 23(1)(a) of the of the Therapeutic Goods Act or whether that should be decided at the point of evaluation under s 25 of the Therapeutic Goods Act. It is common ground that that evaluation has not occurred. The applicant sought to add an alternative claim, considered more fully below at [13]-[23] and [81]-[82], that if what the respondents did was a disposition of the applicant's application then what the respondents did was an "initial decision" for the purposes of s 60. As I have indicated, the underlying dispute between the parties is the question whether the goods fall within Sch 4 to the Poisons Standard. Both the applicant and the respondents submitted that the Court could and should decide this issue either in part, as a matter of construction, or in whole, as a matter of the merits. As will appear, I do not accept this submission.

The application to this Court 6 The originating application sought judicial review of the following: 1 The First Respondent's refusal ("the Refusal") to evaluate the Applicant's application ("the Application") dated 29 June 2015 for registration of the Voke Inhalator nicotine 0.43mg pressurised inhalation aerosol can ("the Voke Inhalator") in the Australian Register of Therapeutic Goods ("the Register"); 2 The Second Respondent's decision of 24 September 2015 that the Application is not a valid application ("the September Decision"); 3 The Third Respondent's decision of 16 October 2015 that the Application does not comply with s. 23(1)(a) of the Therapeutic Goods Act 1989 ("TG Act") ("the First October Decision"); 4 The First Respondent's decision of 20 October 2015 that the Application does not comply with s. 23(1)(a) of the Therapeutic Goods Act 1989 ("TG Act") ("the Second October Decision"); and 5 In the alternative to 2, 3 and 4 above, the conduct engaged in by or on behalf of the First Respondent and/or the Second Respondent and/or the Third Respondent for the purpose of making the September Decision and/or the First and/or Second October Decisions ("the Conduct"). 7 As will appear, it is sufficient for present purposes to focus on the letter of 16 October 2015, described at [3] above, identified by the parties as the First October Decision. 8 The prayers for relief in the originating application were as follows: On the grounds stated below, the Applicant claims: 1. Pursuant to s. 21 of the Federal Court of Australia Act, a declaration that the Application was a valid application for the purposes of s. 23 of the TG Act. 2. Pursuant to s. 16 of the ADJR Act, ss. 39B(1) and 39B(1A)(c) of the Judiciary Act, and/or ss. 23 and 32 of the Federal Court of Australia Act, an order setting aside the September Decision. 3. Pursuant to s. 16 of the ADJR Act, ss. 39B(1) and 39B8(1A)(c) of the Judiciary Act, and/or ss. 23 and 32 of the Federal Court of Australia Act, an order setting aside the First October Decision. 4. Pursuant to s. 16 of the ADJR Act, ss. 39B(1) and 39B(1A)(c) of the Judiciary Act, and/or ss. 23 and 32 of the Federal Court of Australia Act, an order setting aside the Second October Decision. 5. Pursuant to s. 16 of the ADJR Act, ss. 39B(1) and 39B(1A)(c) of the Judiciary Act, and/or ss. 23 and 32 of the Federal Court of Australia Act, an order requiring the First Respondent to determine the Application according to law. 6. Costs. 7. Such further or other order as the Court thinks fit.

The respondents' notice of objection to competency, the proper parties and the jurisdiction of the Court 9 The respondents filed a notice of objection to competency directed first to the decision contained in the letter dated 24 September 2015 from Ms Gaelene Pyke to the applicant. The respondents contended that this was not a justiciable decision under s 5 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) because it was not the final or operative or ultimate decision as it was impliedly replaced by the decision contained in the letter dated 16 October 2015, described as the First October Decision. The notice of objection to competency was directed secondly to the decision contained in the letter dated 20 October 2015 from Ms Trisha Garrett to the applicant's legal representatives. Again it was contended that this was not a discrete justiciable decision under s 5 of the Administrative Decisions (Judicial Review) Act because it was not the operative decision as it was merely a confirmation of the First October Decision contained in the letter dated 16 October 2015. Thirdly, the notice was directed to the claim to review "conduct" under s 6 of the Administrative Decisions (Judicial Review) Act as being conduct engaged in for the purpose of making the Second October Decision. It was contended in the notice that the conduct engaged in for the purpose of making that decision was not justiciable because the Second October Decision was not a justiciable decision under s 5 of the Administrative Decisions (Judicial Review) Act. 10 The applicant indicated that it did not contest the objection to competency. 11 I uphold the objection, on the basis, as I have said, that the proper focus should be on the letter of 16 October 2015 and the applicant's submissions do not contend otherwise. The consequence is that the second respondent should be removed as a party. 12 The notice of objection to competency was not directed to the letter dated 16 October 2015, described as the First October Decision. The respondents' written submissions accept this in stating: "The Respondents have not objected to the competency of the Application insofar as it seeks review of the First October Decision." However the respondents then go on to say that they "accept that the First October Decision is justiciable under the Judiciary Act 1903 (Cth) s 39B(1A)(c)." as a matter arising under a law made by the Parliament. The respondents have therefore not formally objected to the competency of the application under the Administrative Decisions (Judicial Review) Act so far as concerns the letter of 16 October 2015. The respondents did not contend that whether the Court had jurisdiction under the Administrative Decisions (Judicial Review) Act or not made a difference in terms of the availability of grounds of review. Thus the parties accepted that the Court had jurisdiction, at least under s 39B of the Judiciary Act. It will however be necessary to consider whether the letter dated 16 October 2015 constituted or evidenced a decision, in the technical sense of that word, when considering the operation of s 60 of the Therapeutic Goods Act. This was raised expressly by a proposed amendment on the part of the applicant, to which I now turn.

The application to amend 13 At the commencement of the hearing, the applicant sought leave to amend to add to the orders sought the following: 5A Pursuant to s. 21 of the Federal Court of Australia Act, a declaration that the First October Decision was an "initial decision" within the meaning of s. 60 of the TG Act. Again, the First October Decision is a reference to the letter of 16 October 2015. 14 This application to amend was opposed. 15 The proposed amendment did not involve any additional evidence. It was said by the applicant to flow from a statement in the respondents' written submissions that the third respondent was a delegate of the Secretary for the purposes of s 23. 16 Senior Counsel for the respondents submitted that the amendment should not be allowed. The submission was that the letter of 16 October 2015 was plainly not a decision which involved any evaluation of the claimed application that was made, but it was also not a decision refusing an application for internal review. The applicant made no application for internal review, and as a consequence there was no determination in any respect at any time by the first respondent rejecting any such application. All there was in the 16 October 2015 letter was a one-sentence paragraph where the view was expressed in terms of review rights after the decision was made that this was not an initial decision. It was just an indication as to what the applicant's review rights were which was commonly included in many federal administrative decisions. 17 The respondents maintained that the 16 October 2015 letter was not and did not evidence an "initial decision" but submitted that that issue had not been raised until the proposed amendment was advanced. All the respondents had done was respond to the claim that this sentence about review rights indicated an improper purpose of attempting to deprive the applicant of its review rights. 18 The respondents submitted that there were two components to their submission that the 16 October 2015 letter was not an "initial decision". The first was that the view that the application was not an application within 23(1) was not a view formed by anyone in a capacity as the delegate of the Secretary and therefore the definition of "initial decision" in s 60, set out at [26] below, was not engaged. Secondly, there was no decision for the purposes of s 60 which referred to the definition of "decision" in the Administrative Appeals Tribunal Act, set out at [25] below. There was a need for a final, ultimate or operative decision. The respondents referred to Re Rennie and Defence Force Retirement and Death Benefits Authority (1979) 2 ALD 424 at 431-432 and Kowalski v Chief Executive Officer of Medicare Australia [2010] FCA 413; 185 FCR 42. The respondents submitted there was no dispute and no matter which would give the Court jurisdiction under s 21 of the Federal Court of Australia Act 1976 (Cth) to make a declaration of the kind sought in the proposed amended order because no application was made, no decision was made that this was not an initial decision: this was no more than an expression of opinion as to review rights, so it would be futile and hypothetical to make the declaration sought. 19 In my opinion, there is no prejudice to the respondents in allowing the amendment. The respondents put submissions as to why the proposed prayer for relief should fail but those submissions did not persuade me that the amendment should not be allowed on the basis that it was hopeless. 20 To some extent the respondents' opposition to the amendment proceeded on the misconception that the focus of the amendment was on the sentence in the 16 October 2015 letter: "This letter provides a notice that is not an "initial decision" within the meaning of section 60 of the Act." and that this sentence, by virtue of the amendment, was related to the ground that the decision evidenced by the letter was made for an improper purpose or constituted an abuse of process in that it was made for the purpose, or substantially for the purpose, of depriving the applicant of its review rights under s 60. Instead, as explained by Senior Counsel for the applicant, the purpose of the amendment was to bring to a head the competing contentions as to whether or not the 16 October 2015 letter was in truth an "initial decision" within the meaning of s 60. 21 I should say immediately that that there is no basis for inferring that the decision evidenced by the letter of 16 October 2015 was made for the purpose, or substantially for the purpose, of depriving the applicant of its review rights under s 60. I reject that ground. 22 Nevertheless, there is no doubt the parties are at issue as to whether or not the 16 October 2015 letter did constitute an "initial decision" and on that basis there was both a dispute and a matter for the purposes of s 21 of the Federal Court of Australia Act. 23 I allow the amendment. I consider below, at [81]-[82], the merits of the amendment.

The legislation 24 Sections 23, 25 and 31 and of the Therapeutic Goods Act provides relevantly as follows: 23 Applications generally (1) An application for registration or listing of therapeutic goods must: (a) be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and (b) be delivered to an office of the Department specified by the Secretary. (2) An application is not effective unless: (a) the prescribed application fee has been paid; and (b) the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and (ba) if the application is for the registration of restricted medicine - the application is accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and (c) if the Secretary so requires - the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods. (3) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. … 25 Evaluation of therapeutic goods (1) If an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23, the Secretary must evaluate the goods for registration having regard to: (d) whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and (da) if: (i) the applicant is applying for the registration of restricted medicine; or (ii) the applicant is applying for the registration of medicine (other than restricted medicine) and the applicant has been given a notice in writing by the Secretary requiring the applicant to give to the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; the product information given by the applicant in relation to the medicine; and (e) whether the presentation of the goods is acceptable; and (f) whether the goods conform to any standard applicable to the goods; and (fa) whether: (i) the applicable provisions of the Therapeutic Goods Advertising Code; and (ii) the other requirements (if any) relating to advertising applicable under Part 5-1 or the regulations; are complied with in relation to the goods; and (g) if a step in the manufacture of the goods has been carried out outside Australia - whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and (h) if the goods have been manufactured in Australia - whether the goods have been manufactured in accordance with Part 3-3; and (j) whether the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; and (ja) whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and (k) such other matters (if any) as the Secretary considers relevant. Note: The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A. (2) In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include: (a) whether the applicant has provided: (i) if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country that is a member of the European Community or a member of EFTA - an EC/EFTA attestation of conformity in relation to the goods; or (ia) if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country declared by the Minister under section 3B to be covered by a non-EC/EFTA MRA - a non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to the goods; or (ii) in any other case - an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the goods is of an acceptable standard; and (b) whether the applicant has agreed to provide, where the Secretary considers inspection of the manufacturing procedures used in the manufacture of the goods to be necessary: (i) funds for the carrying out of that inspection by the Department; and (ii) evidence that the manufacturer has agreed to such an inspection. (2A) An evaluation under this section of goods in relation to which a period has been prescribed under paragraph 63(2)(da) must be completed within that period. (2B) If therapeutic goods are exempt from the operation of Part 3-3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted. (2C) If a person is exempt from the operation of Part 3-3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3-3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods. (2D) If: (a) therapeutic goods were made outside Australia; and (b) had the goods been made in Australia, they would have been exempt from the operation of Part 3-3; subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted. (2E) A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to: (a) the general standards of manufacturing practice of a particular manufacturer; or (b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods. (2F) For the purposes of subsection (2E), a Convention country is a country that is a party to the Mutual Recognition Convention. (2G) Information referred to in subsection (2E) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3-3 of this Act. (3) After an evaluation under this section of goods has been completed, the Secretary must decide: (a) to register the goods; or (b) not to register the goods. Note: See also sections 25AA (approved product information for medicine), 25AB (registration of therapeutic goods) and 25AC (notice of decision not to register therapeutic goods). … 31 Secretary may require information or documents (1) The Secretary may, by notice in writing given to a person: (aa) who is an applicant for the registration of therapeutic goods; or … require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following: (a) the formulation of the goods; (b) the composition of the goods; (c) the design specifications of the goods; (d) the quality of the goods; (e) the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods; (f) the presentation of the goods; (g) the safety and efficacy of the goods for the purposes for which they are to be used; (ga) whether the goods comply with conditions (if any) on the registration of the goods; (gb) the conformity of the goods to a standard applicable to the goods; (h) whether either of the following has not been complied with in relation to the goods: (i) an applicable provision of the Therapeutic Goods Advertising Code; (ii) any other requirement relating to advertising applicable under Part 5-1 or the regulations; (ha) if the goods are registered in relation to the person - whether the goods are being: (i) supplied in Australia; or (ii) imported into Australia; or (iii) exported from Australia; (j) the regulatory history of the goods in another country; (k) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind. … 25 Relevant to the immediately following definition of "decision" in s 60 of the Therapeutic Goods Act, the Administrative Appeals Tribunal Act 1975 (Cth) provides in s 3(3) as follows: 3 Interpretation … (3) Unless the contrary intention appears, a reference in this Act to a decision includes a reference to: (a) making, suspending, revoking or refusing to make an order or determination; (b) giving, suspending, revoking or refusing to give a certificate, direction, approval, consent or permission; (c) issuing, suspending, revoking or refusing to issue a licence, authority or other instrument; (d) imposing a condition or restriction; (e) making a declaration, demand or requirement; (f) retaining, or refusing to deliver up, an article; or (g) doing or refusing to do any other act or thing. 26 Section 60 of the Therapeutic Goods Act provides as follows, so far as relevant: 60 Review of decisions (1) In this section and section 60A: decision has the same meaning as in the Administrative Appeals Tribunal Act 1975. initial decision means a decision of the Secretary or of a delegate of the Secretary: … (c) under Part 3-2 (registration and listing of therapeutic goods); or … reviewable decision means a decision of the Minister under subsection (3). (1A) … (2) A person whose interests are affected by an initial decision may, by notice in writing given to the Minister: (a) if this Act requires the person to be given notice in writing of the decision, or of particulars of the decision - within 90 days after the notice is given to the person; or (b) otherwise - within 90 days after the earlier of: (i) notice of the decision, or of particulars of the decision, being published in the Gazette or on the Department's website; and (ii) the decision first coming to the person's notice; request the Minister to reconsider the decision. (2A) … (3) Subject to paragraph 60A(2)(b), the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration, may: (a) confirm the initial decision; or (b) revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision. … (8) An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision. 27 Relevant to the power to approve a form are the following provisions of the Acts Interpretation Act 1901 (Cth): 33 Exercise of powers and performance of functions or duties Powers, functions and duties may be exercised or must be performed as the occasion requires (1) Where an Act confers a power or function or imposes a duty, then the power may be exercised and the function or duty must be performed from time to time as occasion requires. … Scope of powers in respect of matters … (3AB) If an Act confers on a person or authority the power to make an instrument (except a legislative instrument, a notifiable instrument or a rule of court): (a) specifying, declaring or prescribing a matter; or (b) doing anything in relation to a matter; then, in exercising the power, the person or authority may identify the matter by reference to a class or classes of matters. Note: This provision has a parallel, in relation to legislative instruments, and notifiable instruments, in section 13 of the Legislation Act 2003. … 28 Schedule 10 to the Therapeutic Goods Regulations refers to regulations 16C(1), 16D(1), 16F(1) and 16G(1). Regulation 16C deals with the periods within which certain evaluations must be made and refers in regulation 16C(1) to an evaluation of a medicine that is a product of a kind specified in Pt 1 of Sch 10. Section 16D deals with periods within which certain applications must be decided and refers in regulation 16D(1) to an application (other than an application to which regulation 16F applies) concerning an evaluation of a medicine that is a product of a kind specified in Pt 1 of Sch 10. Section 16F applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Pt 1 of Sch 10, to vary the information in the Register concerning the medicine. Section 16G concerns shorter evaluation periods in certain circumstances in relation to an application to register a medicine that is a product of a kind specified in Pt 1 of Sch 10. 29 Part 1 of Schedule 10 begins as follows: Part 1 - Evaluation by Office of Medicines Authorisation of prescription and other medicines Column 1 Item Column 2 Product 1 therapeutic goods (except therapeutic goods mentioned in another Part of this Schedule), that: (a) contain a substance mentioned in Schedule 4, 8 or 9 to the Poisons Standard; or ...

30 Part 3 of Schedule 10 provides: Part 3 - Evaluation by Office of Medicines Authorisation of non-prescription and other medicines The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard: Column 1 Item Column 2 Product 1 an antiseptic 2 a sunscreen preparation 3 all other therapeutic goods, except a therapeutic device, not mentioned in another Part of this Schedule 4 an excipient in therapeutic goods mentioned in this Part 5 Therapeutic goods referred to the Office of Medicines Authorisation of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a non-prescription medicine

31 Schedule 4 of the Poisons Standard 2015 states in relation to nicotine: NICOTINE in preparations for human therapeutic use except for use as an aid in withdrawal from tobacco smoking in preparations for oromucosal or transdermal use. (Original emphasis.) 32 In Pt 1 of the Poisons Standard the following definitions appear: "Oromucosal use" means administration to the oral mucosa, specifically the oral cavity and/or the pharynx. … "Transdermal use" means application to the skin primarily for systemic effect. 33 It is the former which is presently relevant.

The evidence 34 The applicant read two affidavits affirmed by Brian James Whittaker, solicitor, the first being dated 23 October 2015 and the second 2 November 2015. There was no objection to these affidavits. 35 Mr Whittaker deposed in his first affidavit that the Voke Inhalator dispensed nicotine to users via a pressurised inhalation aerosol can. He referred to the application made by Nicovations on 29 June 2015 to register the Voke Inhalator on the Register of Therapeutic Goods. The balance of the affidavit annexed correspondence between the parties. Mr Whittaker's second affidavit had as a confidential exhibit a copy of the 29 June 2015 application submitted by Nicovations. If printed, the application consisted of 13 volumes. 36 The respondents read an affidavit affirmed by Michael Jonathan Will, solicitor. The early paragraphs of Mr Will's affidavit relate to delegations by the Secretary of the Department of Health. The relevant effect of these paragraphs is that the Secretary had delegated to the third respondent Dr Kayali a number of powers, including powers under ss 23 and 25 of the Therapeutic Goods Act. 37 The balance of Mr Will's affidavit concerns approved forms. The following forms are said to have been approved under s 23(1): (i) a form for the purposes of applications for the registration of a medicine of the kind specified in Pt 3 of Sch 10 of the Therapeutic Goods Regulations; (ii) three forms for the purposes of applications for, or in relation to, the registration of a medicine referred to in regulation 16C of the Therapeutic Goods Regulation that is a product of a kind specified in Pt 1 of Sch 10 of the regulations. Those three forms were: (a) a Pre-submission planning form - Category 1 and Category 2 applications; (b) the PREMIER Prescription Medicines Electronic Lodgement facility, for applications to register a new chemical entity or new generic medicine; and (c) Application for the registration or to vary the Conditions of Registration, of Prescription Medicines dated October 2007. 38 Since emphasis was placed by the respondents on the terms of the approvals and the purpose for which forms were approved, I set out the relevant approvals in more detail. 39 For over the counter medicines the relevant approval was: APPROVAL UNDER SECTION 23 OF THE THERAPEUTIC GOODS ACT 1989 IN RELATION TO AN APPLICATION FOR REGISTRATION FOR OVER THE COUNTER MEDICINES I, Peter Bird, Head of Office of the Office of Medicines Authorisation of the Therapeutic Goods Administration (the TGA), a delegate of the Secretary of the Department of Health and Ageing for the purposes of section 23 of the Act and acting under that provision, HEREBY: 1. Approve the following to be the form under subsection 23(1) of the Therapeutic Goods Act 1989 for the purpose of applications for the registration of a medicine of the kind specified in Part 3 of Schedule 10 of the Therapeutic Goods Regulations 1990: • The form in the eBS electronic lodgement facility, as that form appears on and from 9th April 2014 and that is accessed via the 'Secure Login' link on the TGA eBusiness Services website (http:/www.ebs.tga.gov.au). 2. Require, under s 23(3) of the Act, that an application of the kind referred to in paragraph 1 above must be submitted electronically through the 'Over The Counter Medicine' link on the TGA eBusiness Services website (http:/www.ebs.tga.gov.au). Note 1: The reference to Part 3 of Schedule 10 of the Regulations indicates that this form is not relevant to applications for registration made under section 23 of the Act for prescription medicines or registered complementary medicines. Peter Bird Delegate of the Secretary 20 June 2014 40 For prescription medicines the relevant approval was: Approval of forms for applications under section 23 of the Therapeutic Goods Act 1989 for registration of therapeutic goods I, Peter Bird, Head, Office of Medicines Authorisation in the Therapeutic Goods Administration and delegate under subsection 57(1) of the Therapeutic Goods Act 1989 (the Act) of the Secretary of the Department of Health, for the purpose of subsection 23(1) of the Act hereby: … 3. APPROVE the following to be the forms for the purpose of applications for or in relation to the registration of a medicine referred to in regulation 16C of the Regulations that is a product of a kind specified in Part 1 of Schedule 10 of the Regulations (other than applications referred to in paragraph 2): a. the Pre-submission planning form - Category 1 and Category 2 applications, dated April 2014 and described as Version 2.1; and b. for such applications to register a new chemical entity or a new generic medicine- the Prescription Medicines (PREMIER) Electronic Lodgement facility, accessible via the 'Prescription Medicines' link on the TGA eBusiness Services website (http:://www ..ebs..tga..gov.au); and c. for such applications other than applications to register a new chemical entity or a new generic medicine - the form Application for the Registration, or to vary the Conditions of Registration, of Prescription Medicines dated October 2007, to the extent that it applies in relation to such applications. Note 1: … Note 2: The reference to Part 1 of Schedule 10 of the Regulations indicates that this form is not relevant to applications for registration made under section 23 of the Act for over-the-counter medicines or registered complementary medicines. Peter Bird Delegate of the Secretary 1 May 2014

The submissions of the parties 41 The applicant's submissions dated 25 February 2016 emphasised that the 29 June 2015 application was made in the form approved for the registration of over the counter medicines. The applicant submitted that the application being on that form and that form having been approved in writing by a delegate of the Secretary, s 23 was satisfied. As s 23 was satisfied, the applicant submitted, it was not open to the Therapeutic Goods Administration, or any of its officers, to refuse to accept the application. The heart of the error, the applicant submitted, was that the reasons for holding that the application did not comply with s 23 related to matters that should be determined as part of the evaluation of the application rather than at the outset as a matter relevant to the validity of an application. The applicant submitted that it was the Secretary who evaluated goods for registration and the Secretary's decision was subject to complete review. It could not be a correct construction that an application could only be a valid application if the applicant first satisfied the Secretary that the goods fell within Pt 3 of Sch 10. That begged the question of how the Secretary was to be so satisfied in circumstances where the application was refused by an officer of the Therapeutic Goods Administration prior to formal evaluation by the Secretary. Moreover, the applicant submitted, the determination of that issue required consideration of matters requiring a significant scientific expertise. These were matters that must be determined in the evaluation stage, and could not be pre-emptively determined by an officer in a refusal to accept an application form. For example, there was evidence within the application that the Voke Inhalator was for oromucosal use. The "route of administration" was specified in the application to be "oromucosal". The applicant sought to have the Voke Inhalator entered in the register as an over the counter medicine. The applicant had submitted the form specified for registration of over the counter medicine. 42 A concern of the applicant was that the decision of the third respondent refusing to accept the application was not a decision to which s 60, dealing with appeal rights, applied. 43 The respondents submitted that the applicant advanced the following propositions, each of which should be rejected: (i) the application was made on a form approved by the Secretary's delegate under s 23 and therefore met the requirements of s 23(1)(a); (ii) the Voke Inhalator was not a medicine of a kind listed in Pt 1 of Sch 10; (iii) therefore the making of the application on the over the counter form met the requirements of s 23(1)(a); (iv) the Secretary had a duty under s 25 to evaluate the application. 44 The respondents submitted that "in accordance with" meant "in conformity with". The respondent submitted that substantial compliance was not sufficient as a contrary legislative intention appeared, conveyed by the use of the word "must" in s 23(1), the context and the evident legislative purpose. The purpose of requiring an application for registration to be made in accordance with an approved form was to ensure that certain kinds of information were provided to the Secretary at the outset, so as to enable the Secretary to determine an application. 45 The respondents submitted that because the applicant used the over the counter form, which was not a form approved for the purpose of making an application for registration of a medicine of the kind to which the Voke Inhalator belonged, the Voke Inhalator application was not made on a form approved by the Secretary and it was therefore not made in accordance with s 23(1)(a). 46 The respondents submitted that the purpose of the Secretary in exercising the power to approve a form may be stated in the instrument of approval. The over the counter approval instrument stated that the over the counter form was made for the purpose of applications for the registration of a medicine of a kind specified in Pt 3 of Sch 10. The prescription medicine approval instrument stated that the prescription medicine form was made for the purpose of applications for the registration of a medicine of the kind specified in Pt 1 of Sch 10. Those forms were approved for separate purposes. The appropriate form, and the "form approved" in accordance with which an application for registration of the Voke Inhalator was required to be made, the respondents submitted, was the prescription medicine form. 47 The respondents' submissions went into some detail as to whether the Voke Inhalator is or involves an oromucosal route of administration. As will appear at [79]-[80] below, it seems to me that this is not a matter which needs to be or should be decided on the present application. 48 The submissions of the applicant in reply dated 24 March 2016 contended that as part of a process described merely as "administrative screening" of the application, conducted prior to any evaluation under s 25, a decision has been made in relation to claims in the application itself. The effect of the decision was to reject the claim made in the application that the Voke Inhalator contains nicotine in preparations for oromucosal use. The applicant submitted there was nothing in the Therapeutic Goods Act that would support the construction adopted by the respondents. The applicant contended that the making of a final decision concerning whether the Voke Inhalator fell within Sch 4 of the Poisons Standard should form no part of the determination of whether an application satisfied s 23. The applicant also submitted, in the alternative, that if the decision may be made refusing an application on the basis that it properly concerned a substance that fell within a particular schedule of the Poisons Standard then it was necessary for the Court to review the correctness of that decision. 49 The applicant also referred in its reply to the question whether the 16 October 2015 letter, contrary to the statement in that letter that it was not an "initial decision" within the meaning of s 60, was such a decision. The applicant there foreshadowed that it would seek a declaration of its rights in that regard. I have referred to this above at [13]-[23] in allowing the amendment to the applicant's originating application.

Consideration 50 The applicant relies on each of the grounds set out in the application for judicial review and it is therefore necessary to refer to each in turn. 51 The central question is whether an application made in the form approved for the registration of over the counter medicines should have been accepted as an application or whether, on the other hand, it was open to the third respondent to refuse to accept the application as being made under s 23 of the Therapeutic Goods Act on the basis stated, that is that application was not made in accordance with a form approved by the Secretary because the Voke Inhalator was a prescription only medicine and not, as contended by the applicant Nicovations, an over the counter medicine. 52 In turn, the point may be stated as whether the applicant was entitled to apply for registration on the basis for which it contended and on the form appropriate to that contention and whether it was open to the third respondent to administer s 23 on the basis that only the "correct" form could be used, that form being the form for the particular therapeutic goods as identified by the third respondent. 53 There is no doubt that the applicant's 29 June 2015 application was made "in accordance with a form approved" as stated in s 23(1)(a) but the respondents submit that because the applicant used the over the counter form, which was not a form approved for the purpose of making an application for registration of the medicine of the kind to which the Voke Inhalator belonged, the application was not made on a form approved by the Secretary and the application was therefore not in accordance with s 23(1)(a). The respondents submit that "a form" in s 23(1)(a) means "the appropriate form" or the form "approved for the purpose" of the application made. The respondents submit that the words "a form approved" do not mean "any form approved under s 23(1)(a)". 54 The contention made by the applicant was that the application should have been treated as an application for registration of the therapeutic goods specified in the application and the question of the accurate identification of the therapeutic goods was excluded from s 23 and fell for consideration only under the subsequent provisions of the Therapeutic Goods Act, particularly s 25. 55 Put differently, the applicant seeks that the Voke Inhalator be entered on the register as an over the counter medicine. The question is at what point in the statutory process that decision is to be made. 56 The applicant contends that it delivered to the relevant office "such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application" within the meaning of s 23(2)(b) of the Therapeutic Goods Act. 57 The respondents' reliance in the approval of 20 June 2014 on the words "for the purpose of applications for the registration of a medicine of the kind specified in Part 3 of Schedule 10" and in the approval dated 1 May 2014 on the words "for the purpose of applications for or in relation to the registration of medicine referred to in regulation 16C of the Regulations that is a product of a kind specified in Part 1 of Schedule 10" seems to me to be misplaced. In my opinion it is not clear that the word "purpose" signifies the Secretary's purpose rather than the applicant's purpose. Furthermore, in my opinion, if an applicant wishes to contend that the application for registration was of a medicine of the kind specified in Pt 3 and not Pt 1, or vice versa, and that contention is not frivolous, the form approved is not apt to prevent that contention being made. Put differently, the words relied on by the respondents in the instruments of approval seem to me to be descriptive rather than prescriptive or proscriptive. 58 There are five grounds of the application, not all of which appear to raise the point on which the application for judicial review falls to be decided.

Ground 1 59 Ground 1 states that the Secretary has failed to determine the application within the meaning of s 7 of the Administrative Decisions (Judicial Review) Act. This ground seems to me to be merely consequential on the resolution of the issue of whether the application dated 29 June 2015 was made in accordance with s 23 of the Therapeutic Goods Act. Nothing more needs to be said about this ground.

Ground 2 60 By ground 2 the applicant contends that the third respondent did not have jurisdiction in effect to decide that the application dated 29 June 2015 was not made in accordance with s 23 of the Therapeutic Goods Act. Since the third respondent was, to the extent she was exercising powers of the Secretary, a delegate this part of Ground 2 fails. Otherwise this ground does not require separate consideration. I explain at [81] below my opinion that the third respondent was not exercising a power of the Secretary in expressing her views in the 16 October 2015 letter.

Ground 3 61 This ground raises the central point being, on the applicant's contention, that as the application was made on the approved over the counter form, and complied with all other applicable statutory requirements, it was not open to the third respondent to determine that the application did not comply with s 23(1)(a). It will be necessary to consider this ground in greater detail below.

Ground 4 62 This ground puts ground 3 in a different way, that is, that the third respondent applied the incorrect statutory test to s 23 by applying the test applicable to determine the registrability of the Voke Inhalator under s 25(3) of the Therapeutic Goods Act. This ground raises the same point of construction as ground 3.

Ground 5 63 Again, this ground puts ground 3 in a different way, that is, the third respondent took into account irrelevant considerations and failed to take into account relevant considerations. The former include the third respondent's opinion as to the outcome of the evaluation and the latter including that the applicant sought that the Voke Inhalator be evaluated as an over the counter medicine. I have already considered and dismissed at [21] above that part of ground 5 which claimed that there was an improper purpose or an abuse of process. It is not necessary to say anything further about ground 5. 64 I turn then to the central issue in the application, which is one of statutory construction, that is, the relation between s 23 and s 25 of the Therapeutic Goods Act. 65 There can be no doubt that the statutory obligation on the Secretary to evaluate therapeutic goods for registration under s 25 arises only where an application is made for the registration of those therapeutic goods "in relation to a person in accordance with section 23". But the present question is concerned with whether or not the application dated 29 June 2015 was such an application. 66 Contrary to the submissions of the respondents, I do not see that it assists analysis to inquire whether making an application in accordance with a form is a jurisdictional fact since the question is the proper construction of s 23 in context, which includes the general purpose and policy of the provision: Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28; 194 CLR 355. 67 Similarly, since the jurisdiction of the Court under s 39B of the Judiciary Act does not depend on there being a decision by an officer of the Commonwealth, Plaintiff S157/2002 v Commonwealth [2003] HCA 2; 211 CLR 476 per Gaudron, McHugh, Gummow, Kirby and Hayne JJ at [104], it is not essential to this Court's jurisdiction that s 23 does not in terms confer a power on a decision-maker. For this reason the third respondent should remain as a party, as responsible for the 16 October 2015 letter. 68 Hunter Resources Ltd v Melville [1988] HCA 5; 164 CLR 234, on which the respondents relied, concerned whether or not the mining warden was obliged to refuse an application for a prospecting licence when it was shown that the applicant had failed to comply with the marking out requirements of reg. 59 of the Mining Regulations 1981 (WA). That regulation required a mining tenement be marked out by fixing pegs in the ground "at intervals not exceeding 300 metres along each of the boundary lines". The majority held that the warden was so obliged: see at 245 per Wilson J; at 251 per Dawson J; and 257 per Toohey J. I do not regard the decision as of present assistance, apart from emphasising that the question is one of interpretation of the particular statutory provisions before the court. 69 Formosa v Secretary, Department of Social Security (1988) 46 FCR 117 was referred to by the respondents in support of an approach which asked what was the legislative intention as to the effect of non-compliance with a statutory requirement relating to the content of an application or the procedure for making it. Section 159(1) of the Social Security Act 1947 (Cth) required that a claim shall be made in writing in accordance with a form approved by the Secretary. The submission was that it was not fatal to Mrs Formosa's case that there was no claim by her in writing for an age pension in accordance with that section. The plurality, Davies and Gummow JJ, said at 124 that the requirement in s 159(1) that a claim shall be made in writing could not, consistently with the scope and object of the statute, be read as if a claim for a pension was sufficiently made if made orally at an office of the Department to an officer of the Department. The requirement that claims shall be made in writing was not to be characterised as a "mere matter of machinery for carrying out the undoubted purposes of the Act". Their Honours added that the facts of the present case did not show that any oral claim was made by Mrs Formosa for an age pension. Burchett J, in a separate judgment, at 126 agreed that the appeal should be dismissed and did so on the simple ground that Mrs Formosa did not in the relevant period make any claim for an age pension nor, indeed, for any other kind of pension. Therefore, the question whether such a claim, had it been made, would have been sufficient, if made orally, did not actually arise for decision. However, his Honour was unable to concur in the view that s 159 made it mandatory that a claim for a pension should be in writing. His Honour regarded the provision as directory only. 70 I do not regard this decision as of present assistance, not only because it deals with a quite different statute but also because it does not deal with a similar question to that which is before me: that is, it does not deal with whether, for example, if a person applied in writing for an age pension to which, it was assessed, she was not entitled, a lawful course would be for the relevant officer to say that the application was not made in accordance with the form approved by the Secretary. 71 Rodda v Repatriation Commission [2006] FCA 1689; 156 FCR 227 concerned the construction of s 155AC(2) of the Veterans' Entitlements Act 1986 (Cth) which provided that an applicant for review may authorise another person to represent him to respond to a statutory notice but that the authorisation must be in writing. It was held by Madgwick J that an "authorised" person's reply to a dismissal notice was of no effect where the applicant had only orally authorised the person to reply on his behalf: the oral authorisation given by Mr Rodda was not sufficient, such that the response to the notice was of no effect. The respondents relied on this decision to support the submission that the effect of non-compliance with a statutory procedure for an application is a question of legislative intention. I accept, of course, the general principle but I do not find the authority of any assistance where the question is not whether there has been an oral application where the statute requires a written application but whether a written application using a prescribed form is nevertheless non-compliant because there has been an assessment, not a statutory evaluation, and the assessment has concluded that what is being applied for on the prescribed form will not ultimately be granted. 72 The respondents also referred to Re LA (1993) 41 FCR 151 at 158 for the proposition that even if s 25C of the Acts Interpretation Act applied so that strict compliance with the form was not required and substantial compliance was sufficient, that provision was displaced because a contrary legislative intention appeared, conveyed by the use of the word "must", the context, and the evident legislative purpose. The case concerned an application to the Court under s 253M(1) of the Industrial Relations Act 1988 (Cth) which, by reg 98 of the Industrial Relations Regulations 1989 (Cth) "must be … in accordance with Form 11". Gray J held, at 158, that "in accordance with", in that context, meant in complete agreement with. His Honour also appears to have held, at 159, that the word "must" was clearly intended to carry a mandatory requirement and thus constituted a contrary intention to the application of s 25C of the Acts Interpretation Act. In the result, his Honour held that s 51 of the Federal Court of Australia Act 1976 (Cth) saved the proceedings from being invalidated since the provision extended to an "irregularity" and that word was broad enough to encompass failures to comply with mandatory provisions of regulations as to form. 73 In my opinion, Re LA does not assist with the present question, which is not one of strict compliance with a form but whether, as I have said, an application on an approved form may be treated as not being in accordance with s 23 because there has been an assessment, not a statutory evaluation, and the assessment has concluded that what is being applied for on the prescribed form may not or will not ultimately be granted. 74 Furthermore, the recent decision in MZAIC v Minister for Immigration and Border Protection [2016] FCAFC 25, especially at [43]-[50] is inconsistent with the apparent reasoning of Gray J in Re LA as to the significance of the word "must" and of the expression "in accordance with". MZAIC also indicates that s 25C of the Acts Interpretation Act reflects the common law so that it is not necessary, for the principle of substantial compliance to be applied, that an Act prescribes a form. It will be sufficient that, as in the present case, the Secretary approved a form. 75 MZAIC, particularly at [34], also stands against the correctness of the observation made by Finkelstein J in Onea v Minister for Immigration & Multicultural Affairs [1997] FCA 1472; 80 FCR 254, referred to by the respondents, that where there is more than one form and an applicant uses the incorrect form the applicant fails to make an application at all. In my opinion, the aphorism "No other form will do." used by Finkelstein J in Onea at 261 flows directly from his Honour's reference, earlier on that page, to the reasoning in Wu v Minister for Immigration and Ethnic Affairs [1996] FCA 106; 64 FCR 245 (under the name Wang) which was disapproved by the Full Court in MZAIC. 76 In resolving the central contention between the parties, it is important to bear firmly in mind that the issue is not whether the applicant's application for registration of the Voke Inhalator as therapeutic goods will or will not succeed, either at all or by reference to whether those goods are ultimately evaluated to be a prescription medicine in Pt 1 of Sch 10 to the Therapeutic Goods Regulations or evaluated to be a non-prescription medicine (over the counter) within Pt 3 of Sch 10. 77 What has so far been done by the Therapeutic Goods Administration is to make the assessment that the goods, the Voke Inhalator, are ultimately likely to be evaluated to be, or ultimately will be evaluated to be, in Pt 1 of Sch 10 and therefore there has been no application within s 23 because a different form is prescribed for goods which ultimately are assessed to be Pt 1 goods. 78 But this, in my opinion, is to be decided on evaluation under s 25. There is nothing flowing from the applicant's use of the approved form it used, to prevent the determination of the application, that being the relevant purpose of the requirement in s 23(1)(a). The applicant is contending that the Voke Inhalator is to be evaluated to Pt 3 not Pt 1 as a substance not mentioned in Sch 4 of the Poisons Standard as being within the exception to the definition of "nicotine" in that Schedule. The applicant's application under s 23 is made on that basis. To describe the issues in this way shows that the assessment of the ultimate correctness of the competing contentions is not to be made at the point of the correctness of the form used and thus the validity of the application for the purpose of s 23. As I have said, the application for registration by reference to Pt 3 of Sch 10 of the Therapeutic Goods Regulations may fail but that is quite different to saying that the application is not valid, even though it is made on the form approved for such goods, because the proleptic or anticipatory assessment has been made that, on evaluation, the goods would be registered by reference to Pt 1 of Sch 10. 79 Having so determined, it is not appropriate to accede to the parties' application that I should decide in these proceedings whether the definition of "oromucosal" in Pt 1 of the Poisons Standard should be read as if it meant "administration to the oral mucosa only". This seems to me to be a mixed question of fact and law and one which is not appropriate for me to decide merely on the documents, to which I was not taken in detail, and without additional evidence. 80 Similarly, I do not consider it appropriate in these proceedings to determine whether the Voke Inhalator is within the exception in the definition of nicotine in Sch 4 of the Poisons Standard. These are technical or scientific questions and they need to be decided in accordance with the statutory scheme, in the first instance, by the Secretary and then, if necessary, by a reviewable decision of the Minister and on external merits review by the Administrative Appeals Tribunal. 81 I come finally to the question whether the letter of 16 October 2015 was or evidenced an "initial decision" within the meaning of s 60 of the Therapeutic Goods Act. I have concluded that it was not such a decision because although there was a decision, at least in a non-technical sense, by the officer of the Therapeutic Goods Administration, Dr Kayali the third respondent, that the material lodged by Nicovations did not comply with the requirements of s 23(1)(a), this was not a decision of the Secretary of the Department or of the Secretary's delegate as referred to in the definition of "initial decision" in s 60. This is because, in my view, the Secretary was given no relevant decision-making power by s 23. For the reason given at [67] above, it is not necessary to determine whether the view taken by Dr Kayali was a decision within the meaning of the Administrative Appeals Tribunal Act or the Administrative Decisions (Judicial Review) Act but my provisional view is that Re Rennie and Kowalski, relied on by the respondents, are distinguishable and the position taken in the letter of 16 October 2015 had the necessary final or operative quality to be reviewable since the consequence was that the application would not be evaluated under s 25: see Australian Broadcasting Tribunal v Bond [1990] HCA 33; 170 CLR 321 at 335-338 per Mason CJ. 82 That the letter of 16 October 2015 was not or did not evidence an "initial decision" provides substantial support for the construction of the scheme of this part of the Therapeutic Goods Act that a position or conduct which involves an opinion as to the ultimate success of the application, but where there has been no evaluation of the goods under s 25, should not be made referable to whether or not the "correct" approved form has been used for the application.

Conclusion and orders 83 The appropriate order is to quash the assessment by the respondents, made in or evidenced by the letter dated 16 October 2015 sent by the third respondent, Dr Kayali, to the applicant Nicovations, that the application by Nicovations dated 29 June 2015 did not comply with s 23(1) of the Therapeutic Goods Act. I further order that the respondents determine that application according to law. 84 I see no reason to make a specific costs order in relation to the respondents' notice of objection to competency, although I have upheld it. As noted above at [12], by that notice the respondents did not object to the competency of the application under the Administrative Decisions (Judicial Review) Act in respect of the letter of 16 October 2015 although they raised the objection inferentially in their written submissions dated 10 March 2016. In those circumstances it is sufficient if the costs follow the event. I shall order that the respondents pay the applicant's costs of the application to this Court. I certify that the preceding eighty-four (84) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Robertson.