International Animal Health Products Pty Ltd and Australian Pesticides and Veterinary Medicines Authority - [2024] AATA 1038

International Animal Health Products Pty Ltd and Australian Pesticides and Veterinary Medicines Authority [2024] AATA 1038 (10 May 2024)
Division:GENERAL DIVISION
File Number(s): 2023/3297
Re:International Animal Health Products Pty Ltd

APPLICANT

AndAustralian Pesticides and Veterinary Medicines Authority
RESPONDENT

DECISION
Tribunal:Senior Member Dr Linda Kirk
Date:10 May 2024
Place:Sydney

Under s 33(2A) of the AAT Act, the Tribunal directs that the Documents listed in Directions 2 and 3 of the Proposed Directions be provided by the Respondent to the Applicant’s solicitors, counsel and independent expert(s) for use only in these review proceedings
.............[SGD]...........................................................
Senior Member Dr Linda Kirk
Catchwords
PRACTICE AND PROCEDURE – application for approval and registration of a product under s 14(1) Agricultural and Veterinary Chemicals Code – release of documents – whether documents relevant to application – whether non-disclosure obligations apply to release – Respondent directed to release documents
Legislation
Administrative Appeals Tribunal Act 1975 (Cth)
Agricultural and Veterinary Chemicals Code Act 1994 (Cth)
Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth)
Cases
Frugtniet v Australian Securities and Investments Commission (2019) 266 CLR 250
Trout v Minister for Immigration, Citizenship and Multicultural Affairs [2019] FCA 583
REASONS FOR DECISION
Senior Member Dr Linda Kirk
10 May 2024
REVIEWABLE DECISION

On 3 February 2022, International Animal Health Products Pty Ltd (‘the Applicant’) submitted an application with the Australian Pesticides and Veterinary Medicines Authority (‘the Respondent’) for registration of a chemical product, Trimidine Paste, pursuant to s 10(1)(b) of the Agricultural and Veterinary Chemicals Code as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (‘the Agvet Code’).[1]
[1] T Documents, 16-50.
On 24 February 2023, the Respondent gave the Applicant written notice of the proposed decision to refuse the application (‘the Proposed Decision’), pursuant to s 8S of the Agvet Code.[2] This was on the basis that the Respondent was not satisfied that:
a)Trimidine Paste meets the efficacy and safety criteria in accordance with s 14(1)(c) of the Agvet Code;
b)The scientific arguments submitted by the Applicant support the efficacy of Trimidine Paste; and
c)The proposed shelf-life for the application support the safety criteria of Trimidine Paste.
[2] T Documents, 118 – 132.
The Proposed Decision noted that the Applicant nominated the following reference products in its application form (‘the Five Original Reference Products’):[3]
a)Bromotrimidine Paste (APVMA Approval No. 46084);
b)Ilium Sulprim Oral Antibiotic Paste for Horses (APVMA Approval No. 62878);
c)Calesulpha-T Oral Paste for Horses (APVMA Approval No. 62149);
d)Bromotrimidine Powder (APVMA Approval No. 37740); and
e)Trimidine Powder (APVMA Approval No. 37721).
[3] T Documents, 124, [20].
The Proposed Decision then stated:[4]
As indicated in your explanation, the presence of an additional active and the absence of two excipients makes it impossible for [the Respondent] to consider the proposed product “Trimidine Paste” and nominated reference product Bromotrimidine Paste (APVMA Approval No. 46084) as being “similar” within the meaning of clause 1.3 (3) of Part 2 of Schedule 6 to the Agvet Code Regulations. Additionally, it should be noted that [the Respondent] could not establish “close similarity” or "similarity” with [the Five Original Reference Products].
[4] T Documents, 124, [20].
On 18 April 2023, the Respondent made a decision to refuse the application pursuant to s 14(2) of the Agvet Code (‘the Reviewable Decision’).[5] The Respondent was not satisfied that Trimidine Paste meets the:
a)efficacy criteria in accordance with the requirements of s14(1)(c)(i) of the Agvet Code;
b)safety criteria in accordance with the requirements of s14(1)(c)(i) of the Agvet Code;
[5] T-Documents, 219-232.
On 15 May 2023, the Applicant applied to the Administrative Appeals Tribunal (‘the Tribunal’) for a review of the Reviewable Decision.
ISSUE OF SUMMONS
On 10 August 2023, the Applicant filed with the Tribunal a Request to Issue Summons and Draft Summons directed to Randlab Australia Pty Ltd (‘Randlab’), Dehra Veterinary Products (Australia) Pty Ltd (‘Dechra’), and Troy Laboratories Pty Ltd (‘Troy’). The summonses concerned chemical products applied for, and registered, with the Respondent by these companies, specifically Randlab’s ‘Randlab TMPS Oral Paste for Horses’, Dehra’s ‘Calesulpha-T Oral Paste for Horses’ and Troy’s ‘Ilium Sulprim Oral Antibiotic Paste for Horses’.
In respect of each of the chemical products of Randlab, Dechra and Troy, the summonses sought:
a)Copies of all documents submitted with the Respondent including copies of documents containing, identifying or recording the details, results, data, analysis and/or information in relation to:
(i)    any field trials conducted with the product;
(ii)   any bioequivalence studies conducted with the product and bioequivalence discussions with the Respondent ;
(iii)    the formulation of the product;
(iv)    any scientific information or published data to prove the efficacy and safety of the product; and
(v)     any expert analysis.
b)Copies of all documents received from the Respondent including copies of documents containing, identifying or recording:
(i)    any requests for the information identified in paragraph [a] above;
(ii) any interim and final decisions, and the reasons for the decision, as to the registrability of the product under the Agvet Code;
(iii)    any studies, reports and scientific information; and
(iv)    any expert opinions and reports.
On 14 August 2023, each of the summonses were issued by the Tribunal setting a return date of 6 September 2023. The summonses were subsequently served on Randlab, Dechra and Troy by way of personal service.
On 30 August 2023, the Respondent wrote to the Tribunal and indicated its objection to the summons on the following non-exhaustive grounds:[6]
(a)The summonses serve no legitimate forensic purpose. The documents they are likely to encompass will be irrelevant to the Tribunal’s review. The Applicant's proposed product contains different concentrations of the active ingredient, and different excipients, from each of the products the subject of the summonses. This means that assessing the safety and efficacy of those products is a different process and information about them will not materially assist the Tribunal in assessing the Applicant’s product.
(b)There is a specific process for assessing a product when it is claimed to be ‘closely similar’ to a reference product for the purposes of clause 1.2 in Schedule 6 of the Agvet Regulations. That process has not been invoked, and is not relevant, here. The Respondent did consider whether the proposed product could be assessed under clause 1.3 being similar to other products, however, the differences between the proposed products and the other products were such that it could not be assessed on this basis. In these circumstances, information about other registered chemical products is not materially relevant.
(c)Even if the summonses were to be issued, the Respondent considers that the documents the summonses are likely to encompass will contain significant amounts of ‘confidential commercial information’ as defined in s 3 of the Agvet Code. Access to such information is highly unlikely to be granted.
[6] Letter from Respondent to Tribunal dated 30 August 2023.
Each of the third parties who received the summons also wrote to the parties indicating their objections to production.
On 26 September 2023, the Tribunal conducted a Directions hearing to consider the Respondent’s objections to the issue of the summons.
On 28 September 2023, the Applicant wrote to the Respondent annexing to the letter the first version of its Proposed Directions and an Amended List of Issues.[7] The Applicant indicated that it sought to obtain an order under s 33(2A) of the Administrative Appeals Tribunal Act 1975 (Cth) (‘AAT Act’) requiring the Respondent to provide the scientific information relating to the Five Original Reference Products.
[7] Letter from Applicant to Respondent dated 28 September 2023.
The Applicant’s Proposed Directions[8] and the Applicant’s Amended List of Issues[9] identified the following six additional Reference Products (‘the Six Additional Reference Products’) which it contends are also relevant to the Tribunal’s review:
RandlabTMPS Oral Paste for Horses (APVMA Approval No. 83452);
(b)Sulfa-B Paste (APVMA Approval No. 49953);
(c)Sulfa-T Paste (APVMA Approval No. 49397);
(d)VR Tridiazine Paste (APVMA Approval No. 47358);
(e)Keymix Sulphatrim Oral Sulphadiazine and Trimethoprim Medication (APVMA Approval No. 37126); and
(f)Ilium Sulprim Oral Powder (Approval No. 51718).
[8] Applicant’s Proposed Directions [2].
[9] Amended Applicant’s List of Issues [11].
On 4 October 2023, the Respondent replied to the Applicant’s letter dated 28 September 2023 indicating, amongst other things, that if the Applicant sought information within the scope of the summonses that issued to the third parties, then the Respondent would object to a proposed disclosure direction under s 33(2A) of the AAT Act on the same basis as set out in its 30 August 2023 letter.[10]
[10] Letter from the Respondent to the Applicant dated 4 October 2023.
On 16 October 2023, the Respondent wrote to the Tribunal, copying the Applicant, stating that, after considering the Amended List of Issues and the Six Additional Reference Products, it considers that ‘substantially new legal issues’ arose, and the rights of third parties (including the three summonsed parties) would likely be affected. The Respondent requested a re-listing of the matter for a Directions hearing, and for the summons parties to have leave to appear at a further Directions hearing and have an opportunity to consider and respond to the Applicant’s Amended List of Issues.[11]
[11] Email from the Respondent to the Tribunal dated 16 October 2023.
On 17 October 2023, the Applicant wrote to the Tribunal, copying the Respondent, expressing its disagreement with the Respondent’s proposal for further case management, and outlining what it considered to be the relevance of the identified Reference Products.[12]
[12] Letter from Applicant to the Tribunal dated 17 October 2023.
The Tribunal held a Directions hearing on 23 October 2023, at which the Applicant raised its concerns that the Respondent had not complied with section 37 and section 38AA of the AAT Act. These concerns related to the role of the Reference Products in relation to the Respondent’s assessment of the Applicant’s application for approval of Trimidine Paste.
Following the Directions hearing, on 27 October 2023, the Respondent filed and served written submissions “to confirm and explain that the Respondent has complied with s 37 of the [AAT Act].”[13]
[13] Respondent’s Submissions dated 27 October 2023.
In an email to the Tribunal dated 29 October 2023, copied to the Respondent’s solicitors, the Applicant expressed its disagreement with the Respondent’s position as set out in its submissions dated 27 October 2023.[14]
[14] Email from the Applicant to the Tribunal dated 29 October 2023.
On 3 November 2023, the Tribunal held a further Directions hearing. The Applicant again raised the Respondent’s compliance with s 37 and s 38AA of the AAT Act. The Respondent relied on its written submissions dated 27 October 2023 to assert its compliance with s 37 of the AAT Act. The Tribunal made Directions to allow affected third parties an opportunity to be heard in relation to confidential commercial information that may be captured by the Applicant’s Proposed Directions under s 33(2A) of the AAT Act.
On 8 December 2023, the Respondent sent to the Tribunal, copied to the Applicant, a letter which annexed Further Supplementary T Documents.[15]
[15] Letter from the Respondent to the Tribunal dated 8 December 2023 attaching Supplementary T Documents.
On 11 December 2023, the Tribunal conducted a further Directions hearing and listed the matter for an interlocutory hearing on 20 February 2024.
On 29 December 2023, the Applicant sent a letter to the Respondent setting out its concerns in relation to the late filing of the Further Supplementary T Documents.[16]
[16] Letter from the Applicant to the Respondent dated 29 December 2023.
On 23 January 2024, the Respondent sent a letter to the Applicant responding to its letter dated 29 December 2023.[17]
[17] Letter from the Respondent to the Applicant dated 23 January 2024.
INTERLOCUTORY HEARING
On 20 February 2024, the Tribunal held an Interlocutory Hearing to consider the issues relevant to the Applicant’s Proposed Directions and its Amended List of Issues as follows:
Proposed Directions
The Tribunal Directs:
1.    …
2. Pursuant to sections 33(2A), 37(2) and 38AA of the Administrative Appeals Tribunal Act, 1975 (AATA), the Respondent be directed to lodge with the Tribunal by [21 days from the date of these Directions], THE FOLLOWING documents set out below in relation to the reference products listed in paragraphs 10 and 11 of the Amended Applicant’s List of Issues: (i) Ilium Sulprim Oral Antibiotic Paste for Horses (APVMA Approval No. 62878); (ii) Calesulpha-T Oral Paste for Horses (APVMA Approval No. 62149); (iii) Randlab TMPS Oral Paste for Horses (APVMA Approval No. 83452); (iv) Sulfa-B Paste (APVMA Approval No. 49953); (v) Sulfa-T Paste (APVMA Approval No. 49397); (vi) VR Tridiazine Paste (APVMA Approval No. 47358); (vii) Ilium Sulprim Oral Powder (APVMA Approval No. 51718) (collectively, Products), a copy of a document recording, for each Product:
(a) the formulation of the Product as approved by the APVMA including the non-active constituents in the formulation and their concentrations; and
(b) the product specifications (including release and expiry limits and test methods) and physico-chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) of the Product,
and, if no single document records all matters identified in paragraphs (a) and (b) of this Direction 2 for a given Product, copies of such additional documents as may be necessary to address the matters described in paragraphs (a) and (b) of this Direction 2 for that Product.
3. Pursuant to sections 33(2A), 37(2) and 38AA of the AATA, the Respondent be directed to lodge with the Tribunal by [21 days from the date of these Directions], copies of the bioequivalence studies or the bioequivalence discussion in relation to each of the following:
(a) Randlab TMPS Oral Paste for Horses (APVMA Approval No. 83452);
(b) Ilium Sulprim Oral Antibiotic Paste for Horses (APVMA Approval No. 62878); and
(c)   Calesulpha-T Oral Paste for Horses (APVMA Approval No. 62149).
4. Pursuant to section 162(2) of the Schedule – Agricultural and Veterinary Chemicals Code to the Agricultural and Veterinary Chemicals Code Act, 1994, and section 35(4) of the AATA, the Tribunal directs (until further order) that:
(a) each document produced by the Respondent to the Tribunal pursuant to Directions 2 and/or 3 of these Directions be:
i.marked ‘confidential’ and marked ‘produced pursuant to Directions [2 and/or 3] of [these directions]’ (as applicable) by the Respondent; and
ii.produced in such a manner that its confidentiality is preserved;
(b) the documents produced to the Tribunal pursuant to Directions 2 and 3 of these Directions, and any information contained in those documents, be restricted from disclosure other than to the Applicant’s independent legal representatives, counsel and independent experts retained or briefed (as applicable) in relation to the Proceeding, who have signed confidentiality undertakings:
i.in the form attached and marked Annexure A (Confidentiality Undertakings) to these Directions; or\
ii.where the Applicant and the third party registrant for a particular Product (Third Party Registrant) have agreed a separate form of confidentiality undertaking, in the form agreed between the Applicant and that Third Party Registrant.
…
Amended Applicant’s List of Issues
…
Applicant’s Position
9. It is the Applicant’s position that, as Trimidine Paste satisfies the requirements under the Agvet Code, including s14(1)(a), s14(1)(b) and s14(1)(c)(i) of the Agvet Code, it should proceed to registration, and the Respondent erred in finding to the contrary under s14(1)(c)(i) of the Agvet Code.
10. In relation to the criteria pursuant to the Agvet Code, it is the Applicant’s position that the Respondent:
a.erred in finding that the following reference products (dating back to 1995) were not “similar” or “closely similar” to Trimidine Paste, and in finding that the reference products were not otherwise relevant to the assessment under s14(1)(c)(i) of the Agvet Code:
i.Bromotrimidine Paste (APVMA Approval No. 46084);
ii.Ilium Sulprim Oral Antibiotic Paste for Horses (APVMA Approval No. 62878);
iii.Calesulpha-T Oral Paste for Horses (APVMA Approval No. 62149);
iv.Bromotrimidine Powder (APVMA Approval No. 37740); and
v.Trimidine Powder (APVMA Approval No. 37721).
b.erred in giving too much weight to the differences between Trimidine Paste and the reference product Bromotrimidine Paste, namely, the absence of bromhexine hydrochloride HCl and two excipients for flavour (Vanillin crystals) and colour (Polar Brilliant Blue) in Trimidine Paste;
c.erred in giving insufficient weight to the opinion of notable experts in the field, Dr Steven Page and Dr Dennis Scott, even after acknowledging that “both expert opinions stated that the removal of bromhexine from the formulation would not affect efficacy or safety” (SOR10, [22], page 126);
d.in giving insufficient weight to the opinion of notable experts in the field, the Respondent erred in giving too much weight and reliance on scientific papers; and
e.erred in giving insufficient weight to the widespread use of the “potentiated sulphonamide” class of antibiotics in humans and animals for over six decades.
11. In deciding whether Trimidine Paste satisfies the requirements under the Agvet Code (including s14(1)(a), s14(1)(b) and s14(1)(c)(i) of the Agvet Code) and, accordingly, should proceed to registration, regard should also be had to the following reference products which (in addition to those reference products listed in paragraph 10 above) the Applicant regards as “similar’ or “closely similar” to Trimidine Paste and otherwise relevant under s6C and s8C(1)(b) of the Agvet Code:
a.    Randlab TMPS Oral Paste for Horses (APVMA Approval No. 83452);
b.    Sulfa-B Paste (APVMA Approval No. 49953);
c.     Sulfa-T Paste (APVMA Approval No. 49397);
d.    VR Tridiazine Paste (APVMA Approval No. 47358);
e.    Keymix Sulphatrim Oral Sulphadiazine and Trimethoprim Medication (APVMA Approval No. 37126); and
f.   Ilium Sulprim Oral Powder (Approval No. 51718).
12. The Applicant accepts that Trimidine Paste does not comply with an established standard pursuant to s14(1)(c)(ii) of the Agvet Code.
13. In relation to the safety criteria pursuant to s14(1)(c)(i) of the Agvet Code, it is the Applicant’s position that the Respondent:
a.erred in finding that the Chemistry data package only supports a shelf life of 23 months for the following pack sizes: 30g, 60g, and 100g, when stored below 30°C (room temperature); and
b.erred in giving insufficient weight to the data provided by the Applicant.
14. The Applicant does not seek to challenge (on a without admissions basis) the Respondent’s position with respect to the 1.2L standard pail and lid.
15. Further issues may be raised after completion of additional procedural steps in the proceedings.
Issues
16. Whether Trimidine Paste satisfies the requirements under the Agvet Code, and, accordingly, should proceed to registration.
RELEVANT LEGISLATION
Agvet Code

Part 2, Division 2, Subdivision B of the Agvet Code is titled ‘Approval and registration for active constituents, chemical products or labels after assessment’. Section 10 provides for applications to the Respondent for, inter alia, registration of a chemical product:
10   Applications
(1)A person may apply to the APVMA:
(a) for approval of an active constituent for a proposed or existing chemical product; or
(b) for registration of a chemical product; or
(c)   for approval of a label for containers for a chemical product.
(2)The application:
(a) must meet the application requirements; and
(b) for an active constituent or chemical product—must include proposed instructions for use of the constituent or product.
Note:     For meets the application requirements, see section 8A.
Part 1, Division 2 of the Agvet Code is titled ‘General provisions about applications’. Section 8A sets out the requirements for an application:
8A   Definition of meets the application requirements
An application meets the application requirements if:
(a) the application:
(i)   is in writing in the approved form; and
(ii)   is signed by the applicant; and
(iii)is accompanied by so much of the prescribed fee as is required to be paid when the application is made; and
(iv)is lodged with the APVMA; and
(v)   contains, or is accompanied by, any information specified for the application by the APVMA under section 8B or prescribed for the application by the regulations for the purposes of this subparagraph; and
(b) the constituent, product or label in relation to which the application is made complies, or will comply, with any requirement prescribed by the regulations; and
(c)   any requirement made under section 157 or 159 in relation to the application has been complied with; and
(d) any requirement prescribed by another provision of this Code in relation to the application has been complied with; and
(e) any amount (including an amount in respect of a tax or penalty) that is due and payable by the applicant to the APVMA (including under a law of another jurisdiction or the agvet law), has been paid.
Part 1, Division 1, section 6C sets out the information that may be used by the Respondent in exercising its powers and functions under the Code:
6C Right of APVMA to use information
(1)The APVMA may use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under this Code.
(2)Subsection (1) has effect subject to this Code.
Part 2, Division 2, Subdivision B of the Agvet Code contains section 14(1) which provides for the approval and registration by the Respondent of a chemical product:
14 Approval and registration
(1)The APVMA must approve the active constituent or label, or register the chemical product, if it is satisfied:
(a)that the application meets the application requirements; and
(b)for an active constituent—that the constituent meets the safety criteria; and
(c)for a chemical product—that the product:
(i)meets the safety criteria, the trade criteria and the efficacy criteria; or
(ii)complies with the established standard for the product; …
Part 1, Division 2, section 8C provides for the information the Respondent may have regard to in determining applications:
8C Information to be taken into account in determining applications
(1) In determining the application, the APVMA:
(a) must have regard to:
(i)the information in, or accompanying, the application as required under section 8B or any other provision of this Code; and
(ii)any information or thing given to the APVMA as required under section 157 or 159 or by section 160A in relation to the application; and
(iii)any submission made in response to an invitation given by the APVMA in relation to the application; and
(b) may have regard to any other matter that it thinks relevant.
(2) Subject to subsection (2A), the APVMA must not take into account any information that:
(a) is given by or on behalf of the applicant in connection with the application; but
(b) is not covered by paragraph (1)(a).
(2A) Subsection (2) does not apply to information that is prescribed by the regulations, and that is provided in the circumstances prescribed by the regulations, for the purposes of this subsection.
(3) This section does not apply in relation to an application under section 122 for a licence.
Division 5, section 8S provides for ‘Notice of certain proposed decisions’ by the Respondent:
8S Notice of certain proposed decisions
(1)The APVMA must give the applicant written notice of what it proposes to do before it:
(a) refuses an application, other than on preliminary assessment; or
(b) approves or registers an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or
(c)   varies, under section 29, relevant particulars or conditions in a way other than set out in the application.
Note:     For notices in relation to reconsiderations, see Division 4 of Part 2.
(2)The notice must:
(a) for notice under paragraph (1)(b)—set out the proposed instructions and relevant particulars; and
(b) for notice under paragraph (1)(c)—set out the proposed variation; and
(c)   include a draft statement of reasons for the proposed course of action; and
(d) set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and
(e) invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice.
Note:This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8X.
(3)The APVMA is not required to take account of anything given in response to the invitation under paragraph (2)(e) that is not related to information:
(a) already given to the APVMA by, or on behalf of, the applicant; or
(b) set out in the notice under paragraph (2)(d).
(4)The APVMA is not required to comply with this section more than once in relation to a particular application.
Part 1, Division 7 of the Agvet Code is titled ‘Access to certain documents and information’. Section 8W provides:
8W Access to certain documents in the possession or custody of the APVMA
(1)A person may, in writing, apply to the APVMA for a copy of, or extract from, a document (other than a document in any part of the Record or Register) in the possession or custody of the APVMA in relation to an approved active constituent or registered chemical product.
(2)The APVMA must provide the copy or extract to the person if the person pays the prescribed fee (if any).
Note 1: See subsections 17(4) and (5) and 18(4) and (5) for access to the Record and Register.
Note 2:This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8X.
Section 8X restricts the disclosure of confidential commercial information under certain provisions of the Agvet Code:
8X Confidential commercial information must not be disclosed under certain provisions
(1)Engaging in conduct in the performance of functions or duties, or the exercise of powers, under any of the following provisions does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162:
(a) subsection 8F(2);
(b) subsection 8S(2);
(c) subsection 8W(2);
(d) subsection 17(4) or (5);
(e) subsection 18(4) or (5);
(f) subsection 34AB(2);
(g) subsection 34AC(2).
(2)Subsection (1) has effect despite subsection 162(1A).
Part 2, Division 2, Subdivision B, section 11 requires the Respondent to make a preliminary assessment of an application within one month following its lodgement:
11 Preliminary assessment
(1)The APVMA must complete a preliminary assessment of the application within 1 month after it is lodged.
(2)If it appears to the APVMA, after completing a preliminary assessment of the application or after defects in the application have been rectified in response to a notice under subsection (3), that the application meets the application requirements, the APVMA must, within 14 days:
(a) give written notice to the applicant:
(i)   stating that the application has passed preliminary assessment and that it will be determined under section 14; and
(ii)   setting out any matters prescribed by the regulations; and
(b) publish a summary of the application that includes any details prescribed by the regulations.
(3) Ifit appears to the APVMA, after completing a preliminary assessment of the application, that the application does not meet the application requirements but that the defects in the application can reasonably be rectified, the APVMA must, within 14 days, give written notice to the applicant:
(a) stating that the application does not meet the application requirements; and
(b) giving particulars of the defects in the application; and
(c)   requiring the defects to be rectified within 1 month.
(3A) The APVMA must refuse the application if:
(a) the APVMA is not satisfied that defects in the application can reasonably be rectified; or
(b) the defects are not rectified to the satisfaction of the APVMA within the period mentioned in paragraph (3)(c).
Note: For notice of refusal, see section 8G.
(4)The APVMA may alter the application, after it has passed preliminary assessment, with the written consent of the applicant.
Part 1, Division 1, section 5A of the Agvet Code provides a definition of ‘meets the safety criteria’:
5A Definition of meets the safety criteria
(1)An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:
(a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(b) is not, or would not be, likely to have an effect that is harmful to human beings; and
(c)   is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
(2)…
(3)For the purposes of being satisfied as to whether a chemical product meets the safety criteria, the APVMA:
(a) must have regard to the following:
(i)   the toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings;
(ii)   the relevant poison classification of the product under the law in force in this jurisdiction;
(iii)how the product is formulated;
(iv)the composition and form of the constituents of the product;
(v)   any conditions to which its registration is, or would be, subject;
(vi)any relevant particulars that are, or would be, entered in the Register for the product;
(via)whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1);
(vii)any matters prescribed by the regulations; and
(b) may have regard to one or more of the following:
(i)   the acceptable daily intake of each constituent contained in the product;
(ii) any dietary exposure assessment prepared under subsection 82(4) of the Food Standards Australia New Zealand Act 1991 as a result of any proposed variation notified under subsection 82(3) of that Act in relation to the product, and any comments on the assessment given to the APVMA under subsection 82(4) of that Act;
(iii)whether any trials or laboratory experiments have been carried out to determine the residues of the product and, if so, the results of those trials or experiments and whether those results show that the residues of the product will not be greater than limits that the APVMA has approved or approves;
(iv)the stability of the product;
(v)   the specifications for containers for the product;
(vi)such other matters as it thinks relevant.
Part 1, Division 1, section 5B of the Agvet Code provides a definition of ‘meets the efficacy criteria’:
5B Definition of meets the efficacy criteria
(1)A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.
(2)For the purposes of being satisfied as to whether a chemical product meets the efficacy criteria, the APVMA must have regard to the following:
(a) whether any trials or laboratory experiments have been carried out to determine the efficacy of the product and, if so, the results of those trials or experiments;
(b) any conditions to which its registration is, or would be, subject;
(c) any relevant particulars that are, or would be, entered in the Register for the product;
(ca) whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1);
(d) any matters prescribed by the regulations.
(3)For the purposes of the operation of this Code in relation to a particular chemical product, the APVMA is required to have regard to the matters set out in subsections (1) and (2) only:
(a) to the extent prescribed by the regulations; or
(b) if there are no such regulations—to the extent that the APVMA thinks the matters are relevant.
Part 1, Division 1, section 3 of the Agvet Code defines ‘confidential commercial information’:
confidential commercial information, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means:
(a) a trade secret relating to the constituent or product; or
(b) any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
(c)   information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that:
(i)   concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
(ii)   relates to the manufacture, distribution or supply of the constituent or product; and
(iii)if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner;
but does not include:
(d) the making of an application for a permit for the use of an active constituent for a proposed or existing chemical product or for the use of a chemical product, if the use of the product proposed in the application is:
(i)   a minor use; or
(ii)   an emergency use; or
(e) any prescribed information relating to the making of an application for a permit, as mentioned in paragraph (d).
Part 10, section 162 of the Agvet Code provides for the disclosure of confidential information:
162 Disclosure of confidential information
(1)A person who is or has been a director, the Chief Executive Officer, or a member of the staff, of the APVMA, or is or has been a consultant to the APVMA, a mediator or arbitrator appointed under this Code, or a co-ordinator designated for a jurisdiction, must not disclose, directly or indirectly, to another person any information about an active constituent for a proposed or existing chemical product, about a chemical product or any of its constituents, or about a label for containers for a chemical product, that:
(a) the person knows to be confidential commercial information; and
(b) was acquired by the person in the performance of such functions or duties or the exercise of such powers.
Penalty: Imprisonment for 2 years.
(1A)Subsection (1) does not apply to the extent that the person engages in the conduct in the performance of functions or duties, or the exercise of powers, under this Code.
Note:The defendant bears an evidential burden in relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal Code.
(2)Subsection (1) does not prohibit the disclosure of information about a constituent or a chemical product to a court in any proceeding but the court must do all things necessary to prevent disclosure of that information to any other person except for the purpose of the proceeding.
(3)Despite subsection (1), a person (the authorised person) that the APVMA has authorised to act under this section may:
(a) disclose confidential commercial information about an active constituent for a proposed or existing chemical product:
(i)   by disclosing a summary of an evaluation of the constituent made by the APVMA or by a prescribed authority or person; or
(ii)   for the purposes of the APVMA’s reconsideration of the approval of the constituent under Division 4 of Part 2—by disclosing the relevant particulars of the constituent; or
(iii)by disclosing, subject to the conditions prescribed by the regulations, information about the toxicity of the constituent and its residues in relation to relevant organisms and ecosystems, including human beings; or
(b) disclose confidential commercial information about a chemical product or any of its constituents:
(i) if the product contains an active constituent that, before the registration of the product, was not contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned—by disclosing a summary of an evaluation that the APVMA has made of the product; or
(ii)   for the purposes of the APVMA’s reconsideration of the registration of the product under Division 4 of Part 2—by disclosing the relevant particulars of the product; or
(iii)by disclosing, subject to any conditions prescribed by the regulations, information about the toxicity of the product and its residues in relation to relevant organisms and ecosystems, including human beings; or
(c)   disclose confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents, to:
(i)   the Commonwealth, a State or a Territory, or an authority of the Commonwealth, of a State or of a Territory; or
(ia) the authorising party for the information; or
(ii)   a person who is expressly authorised to obtain the information by the authorising party for the information; or
(iii)a prescribed authority or prescribed person; or
(d) subject to subsection (4), disclose confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents, to:
(i)   an overseas authority having similar functions to the APVMA; or
(ii)   a prescribed international organisation;
if the authorised person thinks it is reasonable to make the disclosure and the authorising party for the information has consented to the disclosure or the authorised person has made reasonable efforts to obtain that consent.
(4)An authorised person must not disclose information to an authority or organisation under paragraph (3)(d) without the consent of the authorising party for the information unless:
(a) the authorised person has given to the authorising party written notice of the decision to disclose the information; and
(b) a period of 28 days has elapsed since the notice was given.
(6)A person who acquires information because of a disclosure under subsection (3), and any person under the control of that person, is, in respect of that information, subject to the same obligations and liabilities under subsection (1) as if that person were a person performing duties under this Code and had acquired the information in the performance of those duties.
(7)Despite subsection (1), the authorised person may permit confidential commercial information about a constituent or chemical product to be disclosed to a Government, body or person:
(a) for the purpose of enabling the Government, body or person to give advice to the APVMA or to another Government, body or person in accordance with section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; or
(b) if the person is a co-ordinator for a jurisdiction—for the purpose of enabling the co-ordinator to make a recommendation to the APVMA in accordance with paragraph 111(1)(c).
Note: The defendant bears an evidential burden in relation to the matter in subsection (7). See subsection 13.3(3) of the Criminal Code.
(8)A person who acquires information because of a disclosure under subsection (7), and any person who is or has been under the control of that person, must not disclose that information, directly or indirectly, to any person if the person disclosing the information knows that the information is confidential commercial information.
Penalty: Imprisonment for 2 years.
(8A)Subsection (8) does not apply to conduct engaged in with the intention of providing advice to the APVMA in accordance with section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 or making a recommendation to the APVMA in accordance with paragraph 111(1)(c).
Note:The defendant bears an evidential burden in relation to the matter in subsection (8A). See subsection 13.3(3) of the Criminal Code.
(8B)In subsection (8), strict liability applies to the physical element of circumstance, that the disclosure was under subsection (7).
Note: For strict liability, see section 6.1 of the Criminal Code.
(9)If a person who is or has been a director, the Chief Executive Officer, or a member of the staff, of the APVMA, or is or has been a consultant to the APVMA, a mediator or arbitrator appointed under this Code, or a co-ordinator designated for a jurisdiction, has disclosed to another person, except under subsection (3) or (7), any confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents, that was acquired by the first-mentioned person in the performance of functions or duties, or the exercise of powers, under this Code, the other person, and any person who is or has been under the control of the other person, must not disclose that information, directly or indirectly, to any person if the person disclosing the information knows that the information is confidential commercial information.
Penalty: Imprisonment for 2 years.
(9A) In subsection (9), strict liability applies to the physical elements of circumstance, that:
(a) the acquisition of the information by the first-mentioned person was in the performance of functions or duties, or the exercise of powers, under this Code; and
(b) the disclosure mentioned first in that subsection was made other than under subsection (3) or (7).
Note: For strict liability, see section 6.1 of the Criminal Code.
(10)The powers conferred by subsection (7) are in addition to, and do not prejudice, the powers conferred by subsection (3).
(11)A notice published under section 8H or 8J, paragraph 45A(1)(b) or section 47C must not contain any confidential commercial information about an active constituent for a proposed or existing chemical product or about a chemical product or any of its constituents.
(12)This section does not preclude the institution of an action or other civil proceeding against a person in respect of the disclosure, or the proposed, threatened or likely disclosure, by that person of confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents.
(13)A reference in this section to information about an active constituent for a proposed or existing chemical product, or about a chemical product, includes a reference to the fact that:
(a) an application has been made for approval of the constituent or registration of the product; or
(b) an application has been made for a permit in respect of the constituent or product, if the making of the application is confidential commercial information.
(13A) A reference in this section to information about:
(a) an active constituent for a proposed or existing chemical product; or
(b) a chemical product; or
(c)   any of the constituents of a chemical product; or
(d) a label for containers for a chemical product;
includes a reference to information about any substance or thing that was at any time such an active constituent, such a chemical product, such a constituent of a chemical product or such a label, as the case may be.
(14)In this section:
court includes a tribunal, authority or person having power to require the production of documents or the answering of questions.
disclose, in relation to information, means give or communicate in any way.

Part 10, section 167 provides, inter alia, for the review by the Tribunal of decisions made by the Respondent to approve a chemical product:
Review of decisions by Administrative Appeals Tribunal167
(1)An application may be made to the Administrative Appeals Tribunal for review of the following decisions of the APVMA:
(a) a decision under subsection 14(1), 14C(7), 14D(7) or 14E(8) to approve or register a constituent, product or label:
(i) with an instruction or relevant particular other than an instruction or particular set out in the application for the approval or registration; or
(ii) subject to particular conditions;
Agvet Regulations
Part 1, Division 1.1 of the Agvet Regulations contains definitions. Regulation 3B defines ‘reference chemical product’:
3B Meaning of reference chemical product
For these Regulations, reference chemical product, for an application under section 10 or 27 of the Code (the primary application), means a chemical product that:
(a)is or was the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and
(b)is referred to in the primary application because information that is relevant to the chemical product is also relevant to the primary application.
Schedule 6 of the Agvet Regulations is titled ‘Application fees and assessment periods’. Part 1, clause 1.2(3) of Schedule 6 provides:
1.2When chemical products are closely similar
…
(3)Subject to clause 1.5, a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if:
(a)the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and
(b)the concentration of the active constituents referred to in paragraph (a) are the same; and
(c)either:
(i)the non‑active constituents in the formulations of the proposed and reference chemical products are the same, or are equivalent substances, at the same or equivalent concentrations; or
(ii)if the non‑active constituents in the formulations of the proposed and reference chemical products are neither the same nor equivalent, the differences in the formulations are minor and are not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues; and
(d)either:
(i)the proposed and reference chemical products specifications (including release and expiry limits and test methods) and physico‑chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) are the same or equivalent; or
(ii)if the specifications and physico‑chemical properties of the proposed and reference chemical products are neither the same nor equivalent, the differences in the specifications and properties are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues; and
Note for paragraphs (c) and (d): Efficacy, safety and residues data are not required to demonstrate similarity of the proposed chemical product to the reference chemical product.
(e)the dose form and formulation type of the proposed and reference chemical products are the same; and
(f)the use patterns (including target animal species, dose rates, routes of administration and withholding periods) and instructions on the labels of the proposed and reference chemical products are the same; and
(g)either:
(i)the claims on the labels of the proposed and reference chemical products are the same; or
(ii)if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.
Part 1, clause 1.3 of Schedule 6 relevantly provides:
1.3 When chemical products are similar
...
(3)Subject to clause 1.5, a veterinary chemical product (the proposed veterinary chemical product) and a reference chemical product are similar if:
(a)the conditions in paragraphs 1.2(3)(a), (b), (e), (f) and (g) are complied with in relation to the products; and
(b)the non‑active constituents in the proposed and reference chemical products have similar properties and are in similar proportions; and
(c)chemistry and manufacture, efficacy or target species safety data is required to demonstrate similarity of the proposed chemical product to the reference chemical product.
Part 1, clauses 1.4 and 1.5 of Schedule 6 provide:
1.4When chemical products are the same
Subject to clause 1.5, a proposed chemical product and a reference chemical product are the same if they are the same in all respects except their names, their distinguishing numbers, and the name and business address of the applicant.
1.5When chemical products are not closely similar, similar or the same
(1)Despite clauses 1.2, 1.3 and 1.4, a proposed chemical product and a reference chemical product are not closely similar, similar or the same if:
(a)the APVMA is required to use information in determining an application in respect of the proposed chemical product; and
(b)the use of the information by the APVMA in determining that application is restricted.
(2)The use of information by the APVMA in determining an application is restricted if the APVMA is restricted from using the information in determining the application by:
(a)Division 4A of Part 2 of the Code; or
(b)Part 3 of the Code.
SUBMISSIONS
Applicant
The Applicant contends that the application for the registration of Trimidine Paste is an application for a generic product, which is well supported in the scientific literature, and which is, in many respects, just another iteration of a well-known class of products, and this is supported by an analysis of the 11 Reference Products on the register in Australia that it has nominated.[18]
[18] Transcript of proceedings, 20 February 2024, 4.
The Applicant contends that the Respondent erred in finding that the Five Original Reference Products were not ‘similar’ or ‘closely similar’ to Trimidine Paste under clause 1.2(3) or clause 1.3 of Schedule 6 of the Agvet Regulations.[19] It further contends that in determining whether Trimidine Paste satisfies the requirements under the Agvet Code (including s 14(1)(a), s 14(1)(b) and s 14(1)(c)(i)) regard should also be had to the Six Additional Reference Products which the Applicant regards as ‘similar’ or ‘closely similar’ to Trimidine Paste and otherwise relevant under s 6C and s 8C(1)(b) of the Agvet Code.[20]
[19] Applicant’s Amended List of Issues [10(a)].
[20] At [11].
The Applicant contends that the question of Trimidine Paste being ‘similar’ or ‘closely similar’ to one or more of the Reference Products under clause 1.2(3) or clause 1.3 of Schedule 6 of the Agvet Regulations, and the broader relevance of the Reference Products to the assessment of efficacy or safety under s 14(1) of the Agvet Code, is a matter for expert evidence for determination at the final hearing.[21]
[21] Applicant’s Further Outline of Submissions on Substantive Issues dated 29 January 2024 [6].
The Applicant’s expert, Dr Dennis Scott, a veterinary scientist with over 40 years’ experience, is of the view that a Reference Product is relevant to his assessment, and to the assessment by the Respondent, of the safety and efficacy of a Proposed Product where, for example, the differences between the Products are minor, and no adverse implications for the safety or efficacy of the Proposed Product could be expected. However, information is required as to the ratio and dose of the active ingredients, and also a consideration of the identity and properties of the excipients.[22] Dr Scott does not have the necessary information about the non-active constituents of the Reference Products, or their chemical product specifications and physico chemical properties, required to comment or make an informed assessment or comparison relevant to clause 1.2(3)(c) and clause 1.2(3)(d) of the Agvet Regulations.[23]
[22] Applicant’s Further Outline of Submissions on Substantive Issues dated 29 January 2024 [14].
[23] Applicant’s Further Outline of Submissions on Substantive Issues dated 29 January 2024 [9].
The Applicant seeks the information set out in Directions 2 and 3 of the Proposed Directions to permit its independent expert(s) to provide reports in these proceedings and requests that the Tribunal make the Proposed Directions under s 33(2A) of the AAT Act.[24]
[24] Applicant’s Further Outline of Submissions on Substantive Issues dated 29 January 2024 [7].
Respondent
The Tribunal should decline to make Directions 2(a) and (b) sought in the Applicant’s Proposed Directions under s 33(2A) of the AAT Act.[25]
[25] Respondent’s Submissions on the Proposed Directions [3].
Insofar as the Proposed Directions and Amended List of Issues refer to the Six Additional Reference Products that were not in the primary application lodged by the Applicant with the Respondent pursuant to s 10(1)(b) of the Code, these Reference Products are outside the scope of the present review before the Tribunal and are therefore not relevant.[26] The Six Additional Reference Products were not referred to in the Applicant’s primary application, and cannot be “reference chemical products” for the purposes of clause 3B of the Agvet Regulations as set out in paragraph [41] above, and cannot be within the scope of the Tribunal’s review, because they were not “referred to in the primary application” made under s 10(1)(b) of the Code.[27]
[26] Respondent’s Submissions on the Proposed Directions [21], [22]-[28].
[27] Respondent’s Submissions on the Proposed Directions [26].
The Respondent argues that this ‘accords with the proper construction’ of s 167(1)(a) and the decision-making power under s 14(1) of the Agvet Code, read in the context of the legislative scheme as a whole.[28] For example, s 11(1) requires the Respondent to “complete a preliminary assessment of the application within 1 month after it is lodged”. These ‘pre-decision requirements’ hinge on the primary application providing sufficient information, including about “reference chemical products”. The statutory scheme defines the scope of the Tribunal’s review, and the Applicant cannot ask the Tribunal to consider new “reference products” which were not identified in its primary application (and not subject to any preliminary assessment) in reviewing a decision under s 14(1) of the Agvet Code.[29] The Tribunal cannot “complete a preliminary assessment” under s 11 and, in reviewing a s 14(1) decision, it must rely on the Respondent having done so based on the information “referred to in the primary application”.[30] For these reasons, the Tribunal cannot consider “reference products” which were not referred to in the primary application, and therefore the Six Additional Reference Products are not relevant to the review.[31]
[28] Respondent’s Submissions on the Proposed Directions [27].
[29] Respondent’s Submissions on the Proposed Directions [27].
[30] Respondent’s Submissions on the Proposed Directions [27].
[31] Respondent’s Submissions on the Proposed Directions [28].
The Respondent contends that Applicant’s reliance on its expert evidence in attempting to satisfy the “close similarity” requirement in clause 1.2(3) of the Agvet Regulations is misplaced. In particular, the Applicant’s claim that it requires more information in relation to the criteria in clauses 1.2(3)(c) and (d) overlooks the cumulative requirements of the clause. That is, clause 1.2(3)(a) and (b) must first be met before clauses 1.2(3)(c) and (d) become relevant.[32] Clause 1.2(3)(b) provides that the “concentration of the active constituents … are the same”. Clause 1.4 provides that “the same” in this context means that “a proposed chemical product and a reference chemical product are the same if they are the same in all respects”. The Applicant concedes that “[t]he concentration of the active constituents are very similar and when dosage is considered, there is close identity in the amount and ratio of the active constituents across all products”.[33] As “very similar” and “close identity” is not “the same in all respects”, a “reference chemical product” cannot be “closely similar”. The “closely similar” criteria cannot be met for any of the Reference Products because the Applicant’s own expert acknowledges that the “concentration of the active constituents” is different “across all products”. Therefore, regardless of whether the Applicant’s expert also believes that he needs “more information” for the criteria in clauses 1.2(3)(c) and (d), those matters cannot be relevant to the review because the mandatory anterior requirement (clause 1.2(3)(b)) cannot be met.[34]
[32] Respondent’s Submissions on the Proposed Directions [29].
[33] Respondent’s Submissions on the Proposed Directions [30].
[34] Respondent’s Submissions on the Proposed Directions [31].
The Applicant is incorrect to rely on expert evidence to suggest that the information sought in Proposed Directions 2(a) and (b) are relevant, particularly on the question of “close similarity”. This overlooks the legal requirements in clause 1.2(3) of the Regulations.[35]
[35] Respondent’s Submissions on the Proposed Directions [21], [29]-[32].
The Tribunal should decline to make the Proposed Directions as a matter discretion, particularly as the material sought by the Applicant is not and cannot become relevant to the question of “close similarity”, is directed ultimately to a false issue in this case, and would cause undue complexity and delay.[36]
[36] Respondent’s Submissions on the Proposed Directions [21], [33]-[37].
CONSIDERATION AND REASONS
The parties agree that the Tribunal’s jurisdiction arises under s 167(1)(a) of the Agvet Code, which relevantly provides that the Tribunal can review “a decision under subsection 14(1) … to approve or register a constituent, product or label”. The Reviewable Decision is a decision made by the Respondent under section 14(1) of the Agvet Code, and accordingly the Tribunal is satisfied it has jurisdiction in this matter.
The central issue before the Tribunal is whether Trimidine Paste, which is a chemical product the Applicant seeks to register, meets the safety criteria in s 5A and the efficacy criteria in s 5B for the purposes of s 14(1)(c)(i) of the Agvet Code.[37]
[37] Respondent’s Submissions on the Proposed Directions [23].
In this interlocutory proceeding, the issue for the Tribunal is whether it should make a direction under s 33A(2) of the AAT Act requiring the Respondent to disclose the documents listed in Directions 2 and 3 of the Applicant’s Proposed Directions (paragraph [26] above) (‘the Documents’).
In considering whether it should make such a direction, the Tribunal has considered:
A.the relevance of the Documents to the central issue of whether Trimidine Paste meets the safety criteria in s 5A and the efficacy criteria in s 5B for the purposes of s 14(1)(c)(i) of the Agvet Code; and
B.whether issues of confidentiality arise in relation to the Documents.
A. Relevance
1) What information is relevant in assessing whether Trimidine Paste meets the safety criteria in s 5A and the efficacy criteria in s5B for the purposes of s 14(1)(c)(i) of the Agvet Code?
Section 6C of the Agvet Code, authorises the Respondent, and the Tribunal on review, to ‘use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under [the Agvet Code].’ Further, section 8C(1)(a) requires the Respondent, and the Tribunal on review, to have regard to information in or accompanying an application for registration of a chemical product, and it may have regard ‘to any other matter that it thinks relevant’: section 8C(1)(b).[38]
[38] Transcript, 9.
As a consequence of the broad powers conferred on it under the Agvet Code to use information obtained by it from any source, and to have regard to any matter it thinks relevant in assessing an application for registration of a chemical product, the Respondent, and the Tribunal on review, is authorised to refer to any information or documents it considers necessary in determining whether a chemical product must be registered under s 14(1) of the Agvet Code.
In its application for registration of Trimidine Paste, the Applicant listed the Five Original Reference Products for reference by the Respondent in making its assessment of whether Trimidine Paste should be registered under section 14(1). The Respondent would not have been prevented from considering the Six Additional Reference Products in making its assessment as to whether Trimidine Paste should be registered had it chosen to do so. The Tribunal on review, standing in the shoes of the Respondent, has the same broad powers to use information obtained by it from any source, and to have regard to information it considers relevant, in assessing whether a chemical product should be registered under the Agvet Code. The Tribunal therefore finds that it is not prevented from having regard to the Six Additional Reference Products in assessing whether Trimidine Paste meets the efficacy and safety criteria for the purposes of s 14(1)(c)(i) of the Agvet Code.
In its oral submissions, the Applicant referred the Tribunal to the High Court’s decision in Frugtniet v Australian Securities and Investments Commission (‘Frugtniet’),[39] and the recent Federal Court decision in Trout v Minister for Immigration, Citizenship and Multicultural Affairs (‘Trout’),[40] which recognise that the Tribunal on review is not limited to the material before the primary decision-maker. In Trout, the Federal Court, cited Bell, Gageler, Gordon and Edelman JJ in Frugtniet in which their Honours summarised the jurisdiction conferred on the Tribunal as follows:[41]
… except where altered by some other statute, which has not occurred here, the jurisdiction conferred on the AAT by ss 25 and 43 of the AAT Act, where application is made to it under an enactment, is to stand in the shoes of the decision-maker whose decision is under review so as to determine for itself on the material before it the decision which can, and which it considers should, be made in the exercise of the power or powers conferred on the primary decision-maker for the purpose of making the decision under review. The AAT exercises the same power or powers as the primary decision-maker, subject to the same constraints. The primary decision, and the statutory question it answers, marks the boundaries of the AAT’s review. The AAT must address the same question the primary decision-maker was required to address, and the question raised by statute for decision by the primary decision-maker determines the considerations that must or must not be taken into account by the AAT in reviewing that decision. A consideration which the primary decision-maker must take into account in the exercise of statutory power to make the decision under review must be taken into account by the AAT. Conversely, a consideration which the primary decision-maker must not take into account must not be taken into account by the AAT.
[39] (2019) 266 CLR 250.
[40] [2023] FCA 583.
[41] At [56] citing Frugtniet at [51] citing Shi v Migration Agents Registration Authority (2008) 235 CLR 286 at [40], [45], [100], [134].
The Tribunal is satisfied that the general principle which permits it to have regard to information not considered by the primary decision-maker is not altered by the statutory scheme contained in the Agvet Code and Agvet Regulations. It does not accept the Respondent’s contention that the definition of “reference chemical products” in clause 3B of the Agvet Regulations limits the Reference Products to which the Tribunal may have regard to those referred to in the primary application made under s 10(1)(b) of the Agvet Code.

It follows that the Tribunal is satisfied that in assessing whether Trimidine Paste meets the safety criteria in s 5A and the efficacy criteria in s5B for the purposes of s 14(1)(c)(i) of the Agvet Code, it may have regard to information obtained by, or provided to, it that it considers relevant, and this information includes the Documents which relate to the 11 Reference Products.
What information is relevant to assessing whether Trimidine Paste is “closely similar” to another product under clause 1.2(3) of the Agvet Regulations?
Under clause 1.2(3) of Schedule 6 of the Agvet Regulations, a chemical product will be deemed ‘closely similar’ to another product if the requirements in sub-clauses (a)-(d) are satisfied. The Applicant contends that the decision-making process under the Agvet Code is not limited by Schedule 6 which is a ‘deeming schedule’. It provides a ‘useful way of comparing products’, but it is primarily relevant to timing and fees.[42]
[42] Transcript of proceedings, 17.
The Tribunal finds that whether a chemical product is deemed ‘closely similar’ to another chemical product for reason that it meets the criteria in clause 1.2(3) of the Agvet Regulations, is not determinative of whether it is relevant to an assessment of whether it meets the safety criteria in s 5A and the efficacy criteria in s 5B for the purposes of s 14(1)(c)(i) of the Agvet Code. Schedule 6 is titled ‘Application fees and assessment periods’ which indicates that it does not purport to provide substantive criteria for the assessment of whether chemical products satisfy the safety and efficacy criteria in the Agvet Code. The guidance provided in clauses 1.2 and 1.3 of the Agvet Regulations as to when products are deemed ‘closely similar’ or ‘similar’ does not limit the power conferred on the Respondent, and the Tribunal on review, to have regard to information pursuant to section 6C and 8C in making an assessment of whether a chemical product satisfies the criteria for registration under s 14(1) of the Agvet Code.
Accordingly, the Tribunal is satisfied that the 11 Reference Products may be considered by the Tribunal in assessing whether Trimidine Paste meets the safety and efficacy criteria under the Agvet Code. Whether one or more of these Reference Products is deemed ‘closely similar’ to Trimidine Paste under clause 1.2(3) is not determinative of whether the Reference Product may be considered in assessing whether Trimidine Paste meets the safety and efficacy criteria under the s14(1)(c)(i) of Agvet Code and should therefore be registered.
3) Should the Tribunal exercise its discretion under s 33(2A) of the AAT Act to make the Proposed Directions?
Having regard to the Tribunal’s broad procedural powers in s 33(1) and the objectives in s 2A of the AAT Act, the Tribunal finds that the making of the Proposed Directions under s 33(2A) of the Act requiring the Respondent to disclose the Documents relevant to the 11 Reference Products would not cause undue delay to the proceedings and is not disproportionate to the importance and complexity of the matter. The Supplementary T documents provided by the Respondent comprise of a redacted document titled ‘Request for Expert Area Advice’ that refers to a number of the Reference Products which is information sought in Directions 2 and 3 of the Proposed Directions. The Respondent has in its possession an unredacted copy of this Advice which it could readily make available to the Applicant’s solicitors, counsel and independent expert(s) without the need to expend time and resources. The disclosure of this information to the Applicant’s expert(s) will facilitate the gathering of information to demonstrate the safety and efficacy of Trimidine Paste which it can then submit as evidence in these review proceedings. This evidence will assist the Tribunal to make its decision on the central issue to be determined in this review. For these reasons, the Tribunal considers it appropriate to exercise its discretion under s 33(2A) of the AAT Act to make Proposed Directions 2 and 3.
B. Confidentiality
Section 162 of the Agvet Code permits the disclosure of confidential commercial information in proceedings, including in a review by the Tribunal. This is subject to the obligation in s 162(2) that the Tribunal “must do all things necessary to prevent disclosure of that information to any other person except for the purpose of the proceeding”. The requirement to “do all things necessary” contemplates that any orders made by the Tribunal to disclose confidential commercial information be limited to use in the review proceedings.
The parties agree that, with one exception, the limitation of use period has expired for the Reference Products.[43] However this does not exclude the need to protect material that falls within the definition of “confidential commercial information”in s 3 of the Agvet Code, consistently with the obligations in s 162 of the Code. The affected third parties were consulted as to the form of the confidentiality undertakings proposed by the Applicant. Only one written response was received from these parties, which proposed some amendments to these undertakings. The Tribunal is satisfied that the affected third parties’ commercial interests will not be adversely affected by the disclosure of the Documents by the Respondent.
[43] Randlab TMPS Oral Paste for Horses (No. 83452) which has a limitation of use period which expires on 27 April 2026.
For the reasons stated above, the Tribunal directs that the Documents be made available by the Respondent to the Applicant’s solicitors, counsel and independent expert(s) consistently with the requirements in s 162 of the Agvet Code.
DECISION
Under s 33(2A) of the AAT Act, the Tribunal directs that the Documents listed in Directions 2 and 3 of the Proposed Directions be provided by the Respondent to the Applicant’s solicitors, counsel and independent expert(s) for use only in these review proceedings.

I certify that the preceding 73 (seventy-three) paragraphs are a true copy of the reasons for the decision herein of Senior Member Dr Linda Kirk

............[SGD]............................................................
Associate
Dated: 10 May 2024

Date of hearing: 20 February 2024

Solicitors for the Applicant: Mr M. Vincent, Spruson & Ferguson

Counsel for the Respondent: Mr T. Liu

Solicitors for the Respondent: Ms A. Gorman, HWL Ebsworth Lawyers

Date of hearing:	20 February 2024
Solicitors for the Applicant:	Mr M. Vincent, Spruson & Ferguson
Counsel for the Respondent:	Mr T. Liu
Solicitors for the Respondent:	Ms A. Gorman, HWL Ebsworth Lawyers