Agricultural Compounds and Veterinary Medicines Amendment Bill

Agricultural Compounds and Veterinary Medicines Amendment Bill EXPLANATORY NOTE GENERAL POLICY STATEMENT The Agricultural Compounds and Veterinary Medicines Amendment Bill (the Bill ) amends the Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act ). The Bill implements policy changes responding to, and building on, recommendations of the Agricultural and Horticultural Products Regulatory Review (the Review ), undertaken by the Ministry for Regulation. The Review made 16 interrelated recommendations to improve the proportionality, efficiency, transparency, and certainty of the pathways for approval of agricultural and horticultural products. The Bill gives effect to the recommendations of the Review that are related to the ACVM Act. The Bill has the following policy objectives: to reduce barriers to accessing new agricultural products, while ensuring that pathways for approval of those products remain proportionate to risk: to modernise and strengthen the legislative framework of the ACVM Act: to support efficient and timely decision-making: to make processes relating to applications and other matters clearer, more consistent, and more flexible: to enhance transparency by improving public notification of applications and other matters. To achieve those objectives, the Bill amends the ACVM Act— to replace a power to make regulations that exempt agricultural compounds from registration with a power for the Director-General of the Ministry for Primary Industries (the Director-General ) to exempt them from registration; and to replace the scheme for provisional registration of trade name products with a scheme for consent for use of agricultural compounds in research and for other purposes; and to clarify that the information that an applicant for registration or a consent may be required to supply includes information obtained from a recognised agency under the ACVM Act, a recognised person under the ACVM Act, or a person with particular qualifications or skills; and to require the Director-General, when evaluating risks and benefits likely to result from the manufacture and use of a trade name product that is the subject of an application to register the product, to have regard to an applicable assessment from a recognised overseas regulator; and to enable recognition of overseas regulators for that purpose; and to require the Director-General to decide an application to vary the conditions on a registered trade name product in accordance with regulations (instead of in accordance with an assessment and decision-making process set out in the ACVM Act); and to enable time frames currently set out in the ACVM Act to be provided for in regulations; and to expressly enable the Director-General to approve specifications relating to manufacturing and other matters and for those specifications to be referred to in conditions imposed by the Director-General on registrations, consents, or certain exemptions; and to expressly enable those specifications to be varied on application; and to allow the Director-General to grant an application for a product that is a prescription medicine if it is prescribed by regulations (as an alternative to the Director-General always having to obtain the consent of the Director-General of Health before granting an application for a product that is a prescription medicine); and to require the Director-General to publicly notify a prohibition or restriction on importing, manufacturing, selling, or using a registered trade name product, or an agricultural compound to which a consent applies, that is being reassessed; and to make the following changes relating to suspending the registration of a trade name product: allowing the Director-General to suspend the registration if the Director-General has reasonable grounds to believe that the product poses a risk to public health, trade in primary produce, human welfare, or agricultural security: expressly requiring a registrant to be given an opportunity to be heard before a suspension (except in the case of an emergency); and to provide a scheme for specifying manufacturing practice standards and for issuing certificates of compliance with those standards; and to modernise requirements to publicly notify applications and other matters that currently provide for notification in the Gazette , so that notification may be done by methods that are most appropriate in the particular case (which may include the Gazette ). The Bill also contains minor and technical amendments, including amendments to improve accessibility for users. DEPARTMENTAL DISCLOSURE STATEMENT The Ministry for Primary Industries is required to prepare a disclosure statement to assist with the scrutiny of this Bill. The disclosure statement provides access to information about the policy development of the Bill and identifies any significant or unusual legislative features of the Bill. A copy of the statement can be found at http://legislation.govt.nz/disclosure.aspx?type=bill&subtype=government&year=2026&no=305 REGULATORY IMPACT STATEMENT A regulatory impact statement is not required for this Bill. CLAUSE BY CLAUSE ANALYSIS Clause 1 is the Title clause. Clause 2 is the commencement clause. Most of the provisions in the Bill, if enacted, will come into force on a date set by the Governor-General by Order in Council or by 2 years after Royal assent (if not brought into force earlier by Order in Council). The reason for the deferred commencement is that regulations will need to be made, and forms for applications and information to accompany applications will need to be approved, to give effect to the relevant provisions of the Bill. The remaining provisions will commence on the day after Royal assent. Clause 3 provides that the Bill amends the Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act ). MAIN AMENDMENTS Clause 4 amends section 2, which is the interpretation section. It inserts new definitions of approved form and approved information so that provisions relating to applications under the ACVM Act can stipulate that an application must be in the approved form and be accompanied by the approved information. ( See also section 53 of the Legislation Act 2019, which extends the power in legislation to approve a form.) It also— repeals a redundant definition; and amends a definition as a consequence of the repeal of section 27 by clause 29 . Clause 5 amends section 4A, which summarises the scheme of the ACVM Act. Section 4A(2) describes 2 mechanisms in the ACVM Act for authorising the use of an agricultural compound. Section 4A is amended to include a third mechanism, which is an assessment of the compound, and consent for its use in research or for obtaining further information to decide whether it should be registered as a trade name product ( see new sections 35AA to 35AAL , inserted by clause 40 ). Clause 6 makes a minor correction to the Part 2 heading. Clause 7 replaces a cross-heading with a subpart heading as part of the restructuring of Part 2 into subparts. Clauses 9 and 41 to 43 insert further subpart headings into Part 2. Clause 8 amends section 6 as a consequence of new section 8AA (inserted by clause 10 ) and new section 35AAD (inserted by clause 40 ). Clause 9 replaces section 8 and inserts a new subpart 2 heading (as part of the restructuring of Part 2 into subparts) and a cross-heading. It re-enacts the existing section 8 with some changes as a consequence of new sections 8AA and 35AAD . The changes are that a person will now be able— to manufacture, sell, or use an agricultural compound in, or import it into, New Zealand if the agricultural compound is exempt from registration as a trade name product under section 8A or new section 8AA (instead of only under section 8A); or to manufacture or sell an agricultural compound in, or import it into, New Zealand if the person holds a consent under new section 35AAD that allows its manufacture or sale; or to use an agricultural compound in New Zealand if— the person holds a consent under new section 35AAD that allows its use; or it has been sold to the person by the holder of a consent under new section 35AAD that allows the agricultural compound to be sold to, and used by, the person or a class of persons to which the person belongs. Clause 10 inserts new sections 8AA and 8AAB and a cross-heading. New section 8AA enables the Director-General of the Ministry for Primary Industries (the Director-General ) to exempt an agricultural compound or a class of agricultural compounds from the requirement to be registered under new subpart 2 of Part 2 . It replaces the existing power for regulations to provide for an exemption. (Section 75(1)(a) is repealed by clause 69 .) An exemption under new section 8AA — is subject to compliance with conditions prescribed by regulations; and may specify further conditions of the exemption; and may disapply or modify conditions prescribed by regulations to the extent allowed by the regulations; and may generally be granted only if the criteria specified in new section 8AA(4) and (5) are met. An exemption under new section 8AA is secondary legislation. New section 8AAB requires a person who belongs to a prescribed class of persons to comply with regulations that set out record-keeping and reporting requirements on agricultural compounds that are exempt under new section 8AA . Clause 11 amends section 8A, which provides that an agricultural compound is exempt from the requirement to be registered under Part 2 if it is exempt from registration under regulations or if it is listed or approved under section 8B or 8C. The amendments are mainly a consequence of removing the power to provide for an exemption by regulations. Clause 12 amends section 8B to reflect the new subpart structure of Part 2 created by the Bill ( see clauses 7, 9, and 41 to 43 ). Clause 13 amends section 8C, which allows the Director-General to approve the importation, manufacture, sale, or use of an agricultural compound without registration in special circumstances. The amendments— replace cross-references as a consequence of new sections 20A and 21A (inserted by clauses 21 and 23 ); and apply new section 23A (inserted by clause 26 ) to allow the Director-General to approve or vary specifications for the purposes of certain conditions imposed on an approval under section 8C; and amend a cross-reference to section 77A, which is renumbered as new section 85 and repositioned in numerical order ( see clause 71 ). Clause 14 amends section 9 as a consequence of new section 8AA ( see clause 10 ). Clause 15 replaces section 10, which requires an application under section 9 to register, or to vary the conditions of, a trade name product to be in the form, and contain the information, specified by the Director-General. New section 10 — now requires the application to be in the approved form and contain the approved information ( see also clause 4 ); and adds that the applicant may be required to supply information they have obtained from other persons, such as a recognised agency or recognised person, or a person with particular qualifications or skills. Clause 16 amends section 12, which relates to information that has been supplied to the Director-General in connection with an application for full or provisional registration and may be withheld under section 9(2)(b) of the Official Information Act 1982 (the OIA Act ). The amendments repeal subsections (2) to (4), which— relate to requests under the OIA Act to release that information in cases where the person who supplied the information has classified it as commercially sensitive; and are reinserted in new section 35AAP ( see clause 40 ) with changes that ensure that the new section generally applies to all applications under new subpart 2 of Part 2 , including an application for a consent under new section 35AAD ). Clause 17 amends section 14 to replace section 14(1) and (2)(e). Section 14(1) currently requires the Director-General to publicly notify an application for registration and sets out the process for doing so. The process for public notification is removed from new section 14(1) and is now the standardised process for public notification set out in new section 82 ( see clause 75 ). New section 14(2)(e) specifies that the closing date for submissions to the Director-General is determined in accordance with regulations (instead of being 30 working days after the date of public notification in every case). Clause 18 amends section 15, which allows the Director-General to waive the requirement to publicly notify an application in certain circumstances. New section 15(4) allows a waiver if— there is an emergency that involves risks to public health, trade in primary produce, animal welfare, or agricultural security; and the product that is the subject of the application is likely to be required for use in that emergency. New section 15(1)(b) is a consequence of amendments that limit sections 20 and 21 to decisions on applications for registration of trade name products, and require decisions on applications under section 9(2) to vary the conditions on a registered trade name product to instead be determined in accordance with regulations ( see clauses 20, 22, and 23 ). Section 15 is also amended to clarify wording. Clause 19 replaces section 16, which contains detailed requirements for time limits relating to when the Director-General must decide an application and publicly notify their decision. Those details will now be set out in regulations. New section 16 requires the Director-General— to decide an application within any period determined in accordance with regulations; and to publicly notify the decision by any date determined in accordance with the regulations. Section 16 also contains provisions that are relocated in new sections 35AAN and 35AAO , with technical drafting improvements ( see clause 40 ). Clause 20 inserts new paragraph (aa) into section 20, which sets out the matters the Director-General must have regard to when evaluating, under section 21, the risks and benefits of a trade name product in considering an application for its registration. New paragraph (aa) sets out a new requirement to have regard to any assessment of a recognised overseas regulator that has been carried out for the purpose of registering, licensing, or authorising an agricultural compound with the same formulation as the trade name product under a comparable legislative scheme to the registration scheme under new subpart 2 of Part 2 . Clause 21 inserts new section 20A , which allows the Director-General to declare a person to be a recognised overseas regulator for the purposes of new section 20(aa) ( see clause 20 ) and sets out criteria for making a declaration. New section 20A also sets out public notification and consultation requirements. Clause 22 amends section 21, which concerns the Director-General’s decision on an application under section 9 for registration of a trade name product or for variation of conditions on a registered trade name product. The amendments limit section 21 to decisions on an application for registration. The amendments also replace subsection (4), which currently provides that the Director-General may not grant an application for a product that is a prescription medicine without the consent of the Director-General of Health. Under new subsection (4) , that consent is not required if the prescription medicine is prescribed by regulations. Clause 23 inserts new section 21A , which concerns how the Director-General must decide an application under section 9(2) to vary the conditions on a registered trade name product. New section 21A provides that the Director-General must make the decision in accordance with regulations. In line with the position currently applying under section 21, new section 21A also provides that the Director-General— may not grant an application relating to a product that is a prescribed medicine unless the Director-General of Health consents or the prescription medicine is prescribed by regulations; and may not grant the application if the trade name product to which it relates contains an agricultural compound that is also a hazardous substance or new organism that has not been approved under the Hazardous Substances and New Organisms Act 1996. Clause 24 — makes several consequential amendments to section 22 (term of registration) arising from the repeal of sections 27 and 30 ( see clauses 29 and 32 ); and replaces the requirement in section 22(3)(b) to give notice in the Gazette when a registration is removed from the register (because it is no longer in force under section 22(1)) with a requirement to publicly notify the removal (as set out in new section 82 ). Clause 25 amends section 23, which allows the Director-General to impose specified conditions on the registration of a trade name product. The amendments mainly— specify additional conditions that may be imposed, which require— the product to be manufactured in accordance with specifications approved by the Director-General under new section 23A ( see new section 23(1)(la) ); or characteristics of the product to conform to those specifications ( see new section 23(1)(lb) ); and modify the condition in section 23(1)(d), which relates to labelling, advertising, or other information requirements, to include a condition requiring those things to be in accordance with specifications approved by the Director-General under new section 23A . Clause 25 also replaces a cross-reference to section 28, which is renumbered as new section 83 and repositioned in numerical order ( see clause 30 ). Clause 26 inserts new section 23A , which allows the Director-General to approve specifications for the purposes of conditions in section 23(1)(d) and new section 23(1)(la) and (lb) . Under new section 23A , a person may apply to the Director-General to vary those specifications. The Director-General must decide the application in accordance with regulations made under the ACVM Act. Clause 27 amends section 24 (register of trade name products) as a consequence of the repeal by clause 69 of the power for regulations to exempt agricultural compounds. Clause 28 amends section 25 to delete a cross-reference to section 27 (which is repealed by clause 29 ) and to insert 2 subsection headings. Clause 29 repeals sections 26 and 27. Those sections relate to applications for, and decisions on, provisional registration of a trade name product. The provisional registration regime is replaced by new provisions for consent for use of agricultural compounds in research and for other purposes ( see clause 40 , which inserts new sections 35AA to 35AAP ). Clause 30 amends section 28, renumbers it as new section 83 , and repositions it in numerical order. Section 28 relates to operating plans that are required as a condition of registration, exemption from registration, or recognition under Part 3A. The amendments are a consequence of new section 8AA , the repeal of section 27, and new section 35AAD ( see clauses 10, 29, and 40 , respectively). Clause 31 amends section 29, which allows the Director-General to reassess a trade name product (or a group of them) registered under section 21 if significant new information related to the use of the product has become available. Section 29 also provides that the reassessment is treated as a new application for registration under section 21. The amendments— replace cross-references as a consequence of new sections 20A, 21A, 23A, and 35AAP ; and update terminology as a consequence of amendments made by clause 56 ; and apply new section 23A(1) to allow the Director-General to approve specifications for the purposes of certain conditions imposed on the trade name product’s registration; and insert new subsection (4) , which generally recreates the substance of section 31 (repealed by clause 35 ) and allows the Director-General to prohibit or restrict the importation, manufacture, sale, or use of the trade name product until a decision on the reassessment is made; and insert new subsection (5) , which requires the Director-General to publicly notify any such prohibition or restriction; and insert new subsection (6) , which sets out a definition of new information that was previously in section 32 (which is repealed by clause 35 ). Clause 32 repeals section 30, which concerns the reassessment of a provisional registration under section 27, as a consequence of the repeal of section 27 by clause 29 . Clause 33 amends section 30A, which allows the Director-General to suspend the registration of a registered trade name product. The amendments replace subsections (1), (3) to (5), and (8) with new subsections (1), (3) to (5), and (8) , respectively, and repeal subsection (9). The effect of the amendments is as follows: the circumstances in which the Director-General may suspend a registration are expanded to include the Director-General having reasonable grounds to believe the product poses a risk to public health, trade in primary produce, animal welfare, or agricultural security: the requirement to give the registrant written notice of the suspension is moved to new section 30B ( see clause 34 ): it is made clearer that importing, manufacturing, selling, or using the product during the period of suspension is prohibited unless authorised by the Director-General (and subject to a condition or requirement imposed under subsection (2)): the requirement to allow a registrant to be heard regarding an extension of the period of suspension is moved from section 30A to new section 30B ( see clause 34 ): public notification of the suspension is now to be in accordance with new section 82 instead of necessarily being by notice in the Gazette ( see clause 75 ): it is made clearer that a registrant’s power to seek a review of a suspension imposed under delegated authority of the Director-General includes seeking a review of an extension of a period of suspension imposed under delegated authority. Clause 34 inserts new section 30B , which consolidates provisions that were in section 30A about giving notice to the registrant of a suspension or an extension of a period of suspension, and giving them an opportunity to be heard (in the case of an extension). Under new section 30B ,— the requirement to give the registrant an opportunity to be heard now also applies to a notice of a suspension; and in cases of an emergency, the registrant is not required to be given the opportunity to be heard before the Director-General suspends, or extends the suspension of, the registration, but must be given that opportunity as soon as practicable after the suspension or extension commences. Clause 35 repeals section 31 (which allows the Director-General to restrict the importation, etc, of a product while it is being reassessed) and section 32 (which defines new information). The content of those sections that relates to the reassessment of a trade name product registered under section 21 (rather than a provisionally registered trade name product) is reinserted in new section 29(4) and (6) . Clause 36 amends section 32A, which allows the Director-General to cancel the registration of a trade name product. The amendments reflect the renumbering of section 77A (right of review of decisions made under delegated authority) as new section 85 and the revised public notification requirements in new section 82 . Clause 37 amends section 33, which provides that no compensation or damages are payable for any loss arising from specified actions under the ACVM Act. The amendments— add to that list of actions— reassessing, suspending, or cancelling a consent under new section 35AAH, 35AAI, or 35AAK (respectively): revoking under section 57 an approval under section 8C or a consent under new section 35AAD : renumber section 33 as new section 84 and reposition it in numerical order. Clause 38 consequentially amends section 34 to reflect the repeal of section 27 by clause 29 . Clause 39 repeals section 35(2) as a consequence of the repeal of section 27 by clause 29 . Clause 40 inserts new sections 35AA to 35AAP . New sections 35AA to 35AAL provide for a new legislative scheme for consent for use of agricultural compounds in research and for other purposes. This replaces the scheme for provisional registration of trade name products formerly in sections 26, 27, and 30 (which are repealed by clauses 29 and 32 ). Many of the provisions in the new legislative scheme are similar to those in the replaced scheme. Under new section 35AA , a person may apply to the Director-General for consent to— import, manufacture, or sell an agricultural compound to enable it to be used for the purpose of obtaining further information on it (to decide whether it should be registered as a trade name product) or in research for other purposes; and use the agricultural compound in obtaining that further information or in that research. The person cannot apply if regulations prohibit use of the agricultural compound or if the compound is exempt under new section 8AA or section 8A. New section 35AAB requires the Director-General to notify the Environmental Protection Authority of an application under new section 35AA . The Director-General may waive that requirement if there is a registered trade name product that is equivalent to the agricultural compound. Under new section 35AAC , the Director-General must decide the application within any period determined in accordance with regulations. New section 35AAD requires the Director-General to grant the application if satisfied that the likely risks of using the agricultural compound can be adequately managed by imposing specified conditions about— the purposes for which the following are sold, released, or used: the agricultural compound: any animals, plants, or primary produce to which the compound has been applied or that have been exposed to it; and disposal of the compound or any such animals, plants, or primary produce. However, the Director-General must not grant the application if the agricultural compound is also a hazardous substance or new organism that has not been approved under the Hazardous Substances and New Organisms Act 1996. The Director-General may impose certain conditions on a consent relating to its purpose and any likely risks. New section 35AAD(5) defines risks. New section 35AAE provides for the period for which a consent is in force. New section 35AAF provides that the conditions that the Director-General may impose on a consent include conditions that require certain matters to be in accordance with specifications approved by the Director-General under new section 35AAG . Those matters are— labelling or advertising of the agricultural compound; and manufacturing of the agricultural compound; and how, the location at which, or how much of the agricultural compound is used; and characteristics of the agricultural compound (including, for example, its formulation, purity, shelf life, packaging, and use). New section 35AAG is similar to new section 23A . It allows the Director-General to approve specifications for the purposes of conditions referred to in new section 35AAF . Under new section 35AAG , a person may apply to the Director-General to vary those specifications. The Director-General must decide the application in accordance with regulations made under the ACVM Act. Under new section 35AAH , the Director-General may reassess a consent if significant new information on the agricultural compound becomes available. The Director-General must consult the consent holder before deciding whether to do so and notify them of the decision when it is made. A decision to reassess the consent is treated as a new application for consent. Part 6 (protection of confidential information) applies to the application as if it were a non-innovative application made under new section 35AA . Non-innovative application is defined in section 72 (as amended by clause 56 ). The Director-General may prohibit or restrict the importation, manufacture, sale, or use of the agricultural compound until a decision is made under new section 35AAD and may publicly notify the prohibition or restriction. New section 35AAH(6) defines new information in a substantially similar way to the definition in section 32 (which is repealed by clause 35 ). Under new section 35AAI , the Director-General may suspend a consent for up to 3 months if the Director-General has reasonable grounds to believe a condition of the consent is not being complied with or the agricultural compound poses a risk to public health, trade in primary produce, animal welfare, or agricultural security. The Director-General may impose conditions and requirements relating to the implementation and operation of the suspension and may direct the consent holder to take action appropriate to deal with any affected agricultural compound and exercise other powers under the ACVM Act. While the consent is suspended, no person may import, manufacture, sell, or use the agricultural compound except as authorised by the Director-General and subject to any condition or requirement imposed. The Director-General may extend the period of suspension once only, for up to a further 3 months. The consent holder has a right of review if a decision to suspend the consent or extend a suspension period is made under delegated authority. Under new section 35AAJ , before suspending or extending the suspension of a consent, the Director-General must notify the consent holder of the suspension and the reasons for it. In the case of a suspension of a consent, the notice must state when the suspension will begin and any conditions or requirements to be imposed. In cases of emergency, the Director-General is not required to give the consent holder an opportunity to be heard before suspending, or extending the suspension of, the registration, but must give that opportunity as soon as practicable after the suspension or extension commences. Under new section 35AAK , the Director-General may cancel a consent if satisfied that the risks arising from the use of the agricultural compound are not being adequately managed. New section 35AAL allows a consent holder to surrender their consent. New sections 35AAM to 35AAP contain provisions of general application to matters in new subpart 2 of Part 2 . New section 35AAM is an adjusted version of section 77 (which is repealed by clause 70 ). Section 77 provides that the registration of a trade name product or the exemption of an agricultural compound from registration does not imply a warranty by the Crown or the Director-General that the product or compound— is reasonably fit for the purpose for which it is sold; or complies with any labelling or other consumer information relating to that compound or product. The adjustments— replace the reference to a registration under section 27 (which is repealed by clause 29 ) with a reference to a consent under new section 35AAD ; and insert a reference to an exemption under new section 8AA . New sections 35AAN and 35AAO generally recreate the effect of section 16(4) to (6) (replaced by clause 19 ). New section 35AAN applies to a requirement for a person to supply information under new subpart 2 of Part 2 . The Director-General may waive the requirement or give directions as to the terms on which the person must supply the information. New section 35AAO allows— the Director-General to vary a time limit imposed under new subpart 2 of Part 2 on the application of a person: the Minister to do so with or without an application if satisfied that the matter to which the time limit applies will be carried out reasonably promptly. The Director-General or the Minister may vary the closing date for submissions in response to public notification under section 14 or new section 20A if satisfied that the persons specified in new section 35AAO(5) have consented to the variation or would not be unduly prejudiced by it. New section 35AAP generally recreates the effect of section 12(2) to (4), which is repealed by clause 16 ( see explanation above). Clause 41 replaces a cross-heading with a new subpart 3 heading as part of the restructuring of Part 2 into subparts. Clause 42 inserts into Part 2 new subpart 4 , comprising new sections 35FA to 35FF . New subpart 4 provides a legislative scheme for specifying manufacturing practice standards for manufacturing agricultural compounds in New Zealand ( standards ) and issuing certificates of compliance with those standards. Under new section 35FA , the Director-General may specify standards by notice. A notice is secondary legislation. Standards may apply to all or some agricultural compounds and relate to matters specified in new section 35FA(2) , including— plant and equipment; and quality assurance and quality control; and qualifications, training, and experience of people engaged in manufacturing agricultural compounds; and manufacturing practices; and procedures for recall of agricultural compounds, record-keeping, and audits of compliance with the standards. Manufacturers must comply with the standards to the extent required by a condition of registration of the compound, of a consent in respect of the compound under new section 35AAD , or of an exemption from the requirement to register the compound ( new section 35FB ). New sections 35FC to 35FF concern certificates of compliance with the standards. A certificate of compliance attests that a manufacturer of specified agricultural compounds has complied with specified manufacturing practice standards and has ensured that the people engaged in the manufacturing have complied with those standards ( new section 35FC ). Under new section 35FD , the Director-General may issue a certificate of compliance on an application made in the approved form (defined in section 2: see clause 4 ). The application must include the approved information (also defined in section 2: see clause 4 ), and the Director-General may request additional information. The Director-General may issue a certificate of compliance whether or not the manufacturer is required to comply with the standards specified in the certificate as referred to in new section 35FB . New section 35FE allows the Director-General to withdraw a certificate of compliance if satisfied that— it was incorrectly or inappropriately given; or events or circumstances occurring since the certificate was issued mean that it no longer holds true or is misleading. On application, the Director-General may reissue a withdrawn certificate as a new certificate, with modifications if appropriate. New section 35FF protects the Crown, the Director-General, and employees of the Ministry for Primary Industries from liability (by reason of the issue, refusal or failure to issue, or withdrawal of a certificate of compliance) for any loss that arises because the relevant authority of an overseas market refuses or fails to admit an agricultural compound intended to be exported to that market. Clause 43 replaces a cross-heading with a new subpart 5 heading as part of the restructuring of Part 2 into subparts. Clause 44 consequentially amends section 39, which allows the Minister to direct that applications under the ACVM Act (with some exceptions) will be decided by the Minister. The net effect of section 39 is that the Minister may direct that applications for full or provisional registration will be decided by the Minister. The amendment changes that net effect by allowing the Minister to direct that an application under new section 35AA will be decided by the Minister (instead of an application for provisional registration). Clause 45 consequentially amends section 42, which concerns Board of Inquiry investigations into specified decisions under the ACVM Act when the Minister has directed (under section 39) that the Minister will decide the application and has forwarded the direction to a Board of Inquiry. The amendments are mainly a consequence of— the repeal of sections 26 and 27, relating to the scheme for provisional registration of trade name products, by clause 29 ; and the replacement of that scheme with the new scheme for consent for use of agricultural compounds in research and for other purposes that is set out in new sections 35AA to 35AAL ; and the limiting of section 21 to the Director-General’s decisions on applications for registration of trade name products ( see clause 22 ); and the insertion of new section 21A , which concerns the Director-General’s decisions on applications to vary the conditions on a registered trade name product. Clause 46 consequentially amends section 44 to replace a cross-reference to section 27 (which is repealed by clause 29 ) with a cross-reference to new section 35AAD . Clauses 47 to 51 amend sections 44K, 44L, 44M, 44ZA, and 44ZE to update cross-references to section 77A (right of review of decisions made under delegated authority), which is renumbered as new section 85 . Sections 44ZA(3) and 44ZE(3), which concern public notification of a suspension of recognition or withdrawal of recognition, respectively, are also amended so that the notice must be given in accordance with new section 82 rather than by notice in the Gazette ( see clauses 50 and 51 ). Clause 52 amends section 46, which provides for appeals against certain decisions of the Director-General to the High Court on a question of law. The amendments— provide that a party to an application for a consent under new section 35AA can appeal against a decision: delete a cross-reference to section 26 (which is repealed by clause 29 ). Clause 53 amends section 55, which sets out offences against the ACVM Act. The amendments create new offences of knowingly— contravening any conditions of a consent granted under new section 35AAD : importing, manufacturing, selling, or using a product while its registration is suspended under new section 35AAI , unless allowed to do so by a condition or requirement imposed under new section 35AAI(2) : contravening or failing to comply with a condition or requirement imposed under new section 35AAI(2) : failing to comply with a direction given under new section 35AAI(6) : making a false representation that any agricultural compound is the subject of a consent under new section 35AAD or exempt from registration under new section 8AA . Clause 54 amends section 57(2), which allows a court to revoke an approval under section 8C if the holder of the approval (or their agent) is convicted of an offence against the ACVM Act. The amendment provides that section 57(2) also applies to a consent under new section 35AAD . Clauses 55 to 67 amend various provisions in Part 6 as a consequence of the replacement of the provisional registration system ( see clauses 29 and 32 ) with a new legislative scheme in new sections 35AA to 35AAL ( see clause 40 ) for consent for use of agricultural compounds in research and for other purposes. Clauses 68 and 73 insert subpart headings into Part 7. New subpart 1 is about regulations and other secondary legislation ( see clause 68 ), and new subpart 2 is about cost recovery ( see clause 73 ). Clause 69 amends section 75, which empowers regulations to be made for specified purposes. The amendments reflect other changes made by the Bill, in particular,— the replacement of the power for regulations to exempt agricultural compounds from the requirement to be registered with a power for the Director-General to grant exemptions under new section 8AA ; and the repeal of sections 26, 27, and 30, which relate to provisional registration of a trade name product ( see clauses 29 and 32 ); and the new legislative scheme in new sections 35AA to 35AAL for consent for the use of agricultural compounds in research and for other purposes ( see clause 40 ). Clause 70 repeals sections 76 and 77. Section 76 is no longer needed because it relates to regulations under section 75(1)(a), which is repealed by clause 69 . Section 77 (about implied warranties) is reinserted as new section 35AAM , with adjustments to— replace the reference to registration under section 27 (which is repealed by clause 29 ) with a reference to a consent under new section 35AAD : include a reference to an exemption under new section 8AA . Clause 71 amends section 77A, which provides for a right of review of specified decisions made under delegated authority. The amendments— renumber section 77A as new section 85 and reposition it in numerical order; and include the following decisions: a decision under new section 21A on an application to vary conditions on a registered trade name product: a decision under new section 35AAD on an application for consent for the use of an agricultural compound in research or for other purposes under new section 35AA : a decision to suspend a consent under new section 35AAI : a decision to cancel a consent under new section 35AAK ; and repeal section 77A(1)(c) (because it relates to decisions under section 27, which is repealed by clause 29 ). Clause 72 renumbers sections 79 and 80 as new sections 86 and 87 , respectively, and repositions them in numerical order. Those sections concern the relationship between the ACVM Act and other Acts, and the correction of errors in the register. Clause 73 replaces a cross-heading with a subpart heading as part of the restructuring of Part 7 into subparts. Clauses 68 and 75 insert further subpart headings into Part 7. Clause 74 amends a reference to certificates of compliance in section 81J(2)(b) so that it refers to a certificate of compliance issued under new subpart 3 or 4 of Part 2 . This reflects the new subpart structure introduced into Part 2 by the amendments in clauses 7, 9, 41, and 42 . Clause 75 inserts a new subpart 3 heading (as part of the restructuring of Part 7 into subparts) and new section 82 . The Bill replaces requirements in various provisions of the ACVM Act to notify matters in the Gazette with a requirement to publicly notify those matters. New section 82 sets out how public notification must be done, which is by 1 or more of the following: notice in the Gazette : publication in major metropolitan daily newspapers: publication on the Ministry for Primary Industries’ internet site: any other way that the Director-General is reasonably satisfied will ensure that the matter is sufficiently notified to members of the public. In deciding which methods of notification are most appropriate in any particular case, the Director-General must consider— the nature and significance of the matter being notified: the desirability of bringing that matter to the attention of people likely to have an interest in it. Clause 76 repeals sections 85 and 86 and a cross-heading, which are spent. Section 85 is the substantive provision that makes the amendments to other Acts set out in Schedule 2. Section 86 repeals and revokes the enactments specified in Schedules 3 and 4. OTHER AMENDMENTS Clause 77 and Schedule 1 insert into Schedule 1 of the ACVM Act the transitional, savings, and related provisions that are related to the amendments in Part 1 of the Bill. Clause 78 and Schedule 2 make consequential amendments to the Animal Welfare Act 1999 and the Hazardous Substances and New Organisms Act 1996. The Parliament of New Zealand enacts as follows: 1 Title This Act is the Agricultural Compounds and Veterinary Medicines Amendment Act 2026 . 2 Commencement This Act comes into force on a date set by Order in Council. However, sections 4(2), 6, 7, 9 (to the extent that it inserts a subpart heading and a cross-heading), 10 (to the extent that it inserts a cross-heading), 14(1), 17(1), 18, 20, 21, 24(6) and (7), 28(1) and (3), 33(1), (2), and (5), 34, 41 to 43, 50(2), 51(2), 68, and 73 to 77 come into force on the day after Royal assent. Any part of this Act that has not come into force 2 years after Royal assent comes into force then. An Order in Council made under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). 3 Principal Act This Act amends the Agricultural Compounds and Veterinary Medicines Act 1997. 4 Section 2 amended (Interpretation) In section 2(1), insert in their appropriate alphabetical order: approved form means a form that is approved by the Director-General approved information means information of a kind that is approved by the Director-General In section 2(1), repeal the definition of operating plan . In section 2(1), definition of registered , delete or section 27 . 5 Section 4A amended (Scheme of Act) In section 4A(2), replace 2 with 3 . After section 4A(2)(a), insert: aa an assessment of the compound, and consent for its use in research or for obtaining further information to decide whether it should be registered as a trade name product, subject to specifically imposed conditions: In section 4A(3)(a), after product) , insert , approved, . 6 Part 2 heading amended In the Part 2 heading, replace and sale with sale, and use . 7 Cross-heading above section 5 replaced Replace the cross-heading above section 5 with: 1 Specific controls relating to importation 8 Section 6 amended (Agricultural compound clearance) In section 6(3)(a)(ii), delete or its provisional registration under section 27 . After section 6(3)(a)(ii), insert: iia the goods are an agricultural compound, are the subject of a consent under section 35AAD , and comply with the conditions imposed on that consent; or In section 6(3)(a)(iii), after section , insert 8AA or . 9 Section 8 replaced (Prohibition on sale, use, manufacture, or import of agricultural compound) Replace section 8 with: 2 Main controls on importation, manufacture, sale, or use of agricultural compounds General restrictions 8 Restrictions on importation, manufacture, sale, or use of agricultural compounds 1 A person may import an agricultural compound into New Zealand only if— a the agricultural compound— i is a registered trade name product; or ii is exempt from registration under section 8AA or 8A; or iii is only to be exported, with or without further processing; or b the person holds a consent under section 35AAD that allows the agricultural compound to be imported into New Zealand. 2 A person may manufacture an agricultural compound in New Zealand only if— a the agricultural compound— i is a registered trade name product; or ii is exempt from registration under section 8AA or 8A; or iii is manufactured for export only; or b the person holds a consent under section 35AAD that allows the manufacture of the agricultural compound. 3 A person may sell an agricultural compound within New Zealand only if— a the agricultural compound— i is a registered trade name product; or ii is exempt from registration under section 8AA or 8A; or b the person holds a consent under section 35AAD that allows the sale of the agricultural compound. 4 A person may use an agricultural compound only if— a the agricultural compound— i is a registered trade name product; or ii is exempt from registration under section 8AA or 8A; or b the person holds a consent under section 35AAD that allows the use; or c the agricultural compound has been sold to the person by the holder of a consent under section 35AAD that allows the sale to and use by— i the person; or ii a class of persons to which the person belongs. 10 New sections 8AA and 8AAB and cross-heading inserted After section 8, insert: Exemptions from registration 8AA Exemption from requirement to register for agricultural compound or class Power to exempt and conditions of exemption 1 The Director-General may exempt any agricultural compound or any class of agricultural compounds from the requirement to be registered under this subpart. 2 An exemption granted under this section is subject to— a any conditions that are prescribed by the regulations and that apply— i generally; or ii in the case of an exempted agricultural compound, to a class of agricultural compounds to which the exempted compound belongs; or iii in the case of an exempted class of agricultural compounds, to a class of agricultural compounds to which the exempted class belongs; and b any conditions specified in the exemption that are not inconsistent with any conditions referred to in paragraph (a) . 3 Despite subsection (2) ,— a an exemption granted under this section may disapply or modify any conditions that are prescribed by the regulations (but only to the extent that the regulations allow those conditions to be disapplied or modified); and b in that case, the exemption is not subject to the disapplied conditions (if any) and is subject to the modified conditions (if any). Preconditions to granting exemption 4 The Director-General may grant an exemption under this section only if satisfied that— a the exemption is not inconsistent with the purpose of this Act as set out in section 4; and b at least 1 of the following applies: i the likely cost of assessing and registering the agricultural compound, or agricultural compounds of the relevant class, under this subpart outweighs the likely risks from the use of that agricultural compound, or those agricultural compounds, without registration; or ii the likely risks of the substance concerned, or substances of the relevant class concerned, being used as an agricultural compound or agricultural compounds are already adequately managed by restrictions that apply under another Act to that substance or those substances ( see subsection (9) ). 5 The Director-General may grant an exemption under this section only if— a the Director-General has done everything reasonably practicable to consult the organisations that the Director-General considers represent the persons who will or may be affected by the exemption; and b those persons have had an opportunity to comment; and c the Director-General has considered those comments. 6 Subsection (5) does not apply if the Director-General considers it desirable in the public interest that the exemption be granted urgently. 7 A failure to comply with subsection (5) does not affect the validity of any exemption granted under this section. Exemption is secondary legislation 8 An exemption granted under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). Definition 9 In this section, substance includes a mixture of substances or a biological compound. 8AAB Requirements relating to records, returns, and information 1 A person who belongs to a class of persons that is prescribed by the regulations must, in accordance with the regulations, keep records on agricultural compounds that are exempt from registration under section 8AA . 2 A person who belongs to a class of persons that is prescribed by the regulations must, in accordance with the regulations, report returns or information to the Director-General on agricultural compounds that are exempt from registration under section 8AA . 11 Section 8A amended (Exemptions from requirement to register) In the heading to section 8A, replace Exemptions with Other exemptions . In section 8A(1), replace Part with subpart . Repeal section 8A(1)(a). Replace section 8A(2) with: 2 An exemption under this section is subject to any applicable conditions imposed under section 8B or 8C (as the case may be). 12 Section 8B amended (Director-General may list as exempt substances generally recognised as safe) In section 8B(1), replace Part with subpart . 13 Section 8C amended (Director-General may approve agricultural compound as exempt in special circumstances) In section 8C(3), replace to 23 and section 25 with , 20, 21, 22, 23, and 25 . After section 8C(3), insert: 3A If a condition is to be imposed on the approval of the agricultural compound under section 23(1)(d), (la), or (lb) (as applied by subsection (3)), section 23A(1) applies, with any necessary or appropriate modifications. 3B Section 23A(2) to (4) applies in relation to the variation of specifications that are approved by the Director-General under section 23A(1) (as applied by subsection (3A) ). In section 8C(8), replace 77A with 85 . 14 Section 9 amended (Application for registration) In the heading to section 9, after registration , insert or variation of conditions . In section 9(1)(b), replace as an agricultural compound under section 8A with under section 8AA or 8A . 15 Section 10 replaced (Form of application) Replace section 10 with: 10 Approved form and information for application 1 An application to register a trade name product, or to vary the conditions of a registered trade name product, must be in the approved form and contain, or be accompanied by, the approved information. 2 Without limiting the approved information that the applicant may be required to supply, the applicant may be required to supply information obtained from a person belonging to a particular class, including, for example, from— a a recognised agency or a recognised person; or b a person who meets specified criteria (including, for example, particular qualifications or skills). 16 Section 12 amended (Director-General to withhold information) Replace the heading to section 12 with Public notification under section 14: information involving trade secrets, etc, to be withheld . Repeal section 12(2) to (4). 17 Section 14 amended (Notification of application) Replace section 14(1) with: 1 On receiving an application, the Director-General must arrange for the application to be publicly notified ( see section 82 ). Replace section 14(2)(e) with: e the closing date by which submissions must be received by the Director-General that is determined in accordance with the regulations; and 18 Section 15 amended (Waiver of notification) Replace section 15(1)(b) with: b the application is made under section 9(2) and the proposed variation of conditions does not affect the evaluation of the risks relevant to the trade name product when compared with the original evaluation under section 21. In section 15(2), replace a trade name product with the trade name product that is the subject of the application . In section 15(3)(a), after product , insert that is the subject of the application . After section 15(3), insert: 4 The Director-General may waive the requirement to publicly notify an application under section 14 if, in the Director-General’s opinion,— a an emergency has arisen that involves risks to public health, risks to trade in primary produce, risks to animal welfare, or risks to agricultural security; and b the trade name product that is the subject of the application is likely to be required for use in that emergency. 19 Section 16 replaced (Time limits and waivers) Replace section 16 with: 16 Time limits relating to applications Date for deciding application 1 The Director-General must decide the application within any period determined in accordance with the regulations. Date by which decision publicly notified 2 The Director-General must publicly notify the Director-General’s decision on the application by no later than any date determined in accordance with the regulations ( see also section 82 ). Guidance note See section 35AAO in relation to the variation of time limits under this subpart. 20 Section 20 amended (Evaluation of risks and benefits) After section 20(a), insert: aa any assessment of a recognised overseas regulator that— i is held by the Director-General; and ii has been carried out by that regulator for the purpose of determining whether to register, or grant a licence or similar authorisation relating to, an agricultural compound that has the same formulation as the trade name product concerned under a legislative scheme that is comparable to the scheme for registration set out in this subpart; and 21 New section 20A inserted (Recognition of overseas regulators for purposes of section 20(aa)) After section 20, insert: 20A Recognition of overseas regulators for purposes of section 20(aa) 1 The Director-General may declare that a person in another jurisdiction is a recognised overseas regulator for the purposes of section 20(aa) . 2 The declaration may apply in relation to all agricultural compounds or a class of agricultural compounds. 3 The Director-General may make a declaration in relation to the person only if the Director-General is satisfied that the following criteria are met: a the person operates in a way that is comparable to the Director-General in regulating agricultural compounds or the class of agricultural compounds concerned: b the person operates under a legislative scheme for regulating agricultural compounds or the class of agricultural compounds that is comparable to the scheme provided for by this subpart: c the person is willing and able to provide assessments of a kind referred to in section 20(aa) to the Director-General: d any criteria prescribed by the regulations. 4 The Director-General may declare that the recognition of a person under this section is withdrawn (in whole or in part) if satisfied that 1 or more of the criteria set out in subsection (3) are no longer met. 5 Before making a declaration under this section, the Director-General must— a publicly notify the Director-General’s proposal to make the declaration ( see section 82 ); and b consult any person that the Director-General considers appropriate; and c have regard to any written submissions received by the Director-General, and the results of consultation, on or before the date specified under subsection (6)(d) . 6 The notice that is published under subsection (5)(a) must— a state that the Director-General proposes to make the declaration; and b state the effect of the proposed declaration; and c invite written submissions in relation to the proposed declaration; and d specify the closing date by which written submissions must be received by the Director-General (being a date that allows for a reasonable period within which submissions must be received). 7 A declaration under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). 22 Section 21 amended (Decision on application) In the heading to section 21, after application , insert to register trade name product . In section 21(1), replace The Director-General must consider any application made under section 9 and with In considering an application made under section 9(1), the Director-General . In section 21(2) and (5), after application , insert made under section 9(1) . Replace section 21(4) with: 4 The Director-General may grant an application made under section 9(1) to register a trade name product that is a prescription medicine (within the meaning of section 3 of the Medicines Act 1981) only if— a the Director-General obtains the consent to grant the application from the Director-General of Health; or b the prescription medicine is, or belongs to a class that is, prescribed by the regulations. 23 New section 21A inserted (Decision on application to vary conditions: section 9(2)) After section 21, insert: 21A Decision on application to vary conditions: section 9(2) 1 The Director-General must decide an application made under section 9(2) in accordance with the regulations. 2 Subject to the provisions of Part 6, the Director-General must give the decision in writing, with reasons, to the applicant and to every person who made a submission. 3 The Director-General may grant an application made under section 9(2) relating to a trade name product that is a prescription medicine (within the meaning of section 3 of the Medicines Act 1981) only if— a the Director-General obtains the consent to grant the application from the Director-General of Health; or b the prescription medicine is, or belongs to a class that is, prescribed by the regulations. 4 The Director-General must not grant an application made under section 9(2) if— a the trade name product to which it relates contains an agricultural compound that is also a hazardous substance or new organism; and b an approval for that substance or organism has not been issued under the Hazardous Substances and New Organisms Act 1996. 24 Section 22 amended (Term of registration) In the heading to section 22, replace Term with Duration . In section 22(1)(a), delete or section 27(3) . In section 22(1)(b), delete 27(6) or . In section 22(1)(c), delete or section 30, . In section 22(3), delete , other than a provisional registration under section 27, . Replace section 22(3)(b) with: b must publicly notify the removal of the trade name product from the register ( see section 82 ); and In section 22(3)(c), replace Gazette notice with public notice required to be given under paragraph (b) . Repeal section 22(4). 25 Section 23 amended (Conditions on trade name products) In section 23(1)(d), after requirements , insert (including, for example, a condition requiring the labelling or advertising of the product to be in accordance with specifications approved by the Director-General under section 23A ) . In section 23(1)(f), replace section 28 with section 83 . After section 23(1)(l), insert: la a condition requiring the product to be manufactured in accordance with specifications approved by the Director-General under section 23A : lb a condition requiring characteristics of the product (including, for example, its formulation, purity, shelf life, packaging, and use) to conform to the specifications approved by the Director-General under section 23A : 26 New section 23A inserted (Approval and variation of specifications) After section 23, insert: 23A Approval and variation of specifications 1 The Director-General may approve specifications for the purposes of any condition to be imposed on the registration of a trade name product under section 23(1)(d), (la), or (lb) . 2 A person may apply to the Director-General to vary any of those specifications. 3 The application must be in the approved form and contain, or be accompanied by, the approved information. 4 Without limiting the approved information that the applicant may be required to supply, the applicant may be required to supply information obtained from a person belonging to a particular class, including, for example, from— a a recognised agency or a recognised person; or b a person who meets specified criteria (including, for example, particular qualifications or skills). 5 The Director-General must decide the application in accordance with the regulations. 27 Section 24 amended (Register of trade name products) Repeal section 24(4). 28 Section 25 amended (Certificate of registration) Before section 25(1), insert: Issue of certificate In section 25(1), delete or section 27 . Before section 25(3), insert: Certificate and application to be kept 29 Sections 26 and 27 repealed Repeal sections 26 and 27. 30 Section 28 amended, renumbered as section 83, and repositioned (Director-General may approve operating plans) After section 28(1)(a)(i), insert: ia a consent under section 35AAD ; or Replace section 28(1)(a)(ii) with: ii exemption under section 8AA or 8A from the requirement to be registered under section 21; or Renumber section 28 as section 83 and reposition it after section 82 (as inserted by section 74 of this Act). 31 Section 29 amended (Reassessment of trade name products) In section 29(3)(a), replace and 17 to 25 with 17 to 20, 21, 22, 23, 24, 25, and 35AAP . After section 29(3)(a), insert: aa if a condition is to be imposed on the registration of the trade name product under section 23(1)(d), (la), or (lb) (as applied by paragraph (a)), section 23A(1) applies; and In section 29(3)(b), replace non-innovative TNP application with non-innovative application made under section 9(1) . After section 29(3), insert: 4 The Director-General may, if the Director-General thinks fit, prohibit or restrict the importation, manufacture, sale, or use of the trade name product or group of trade name products until a decision is made under section 21 (as applied by subsection (3)(a)). 5 The Director-General must publicly notify the prohibition or restriction (if any) ( see section 82 ). 6 In this section, new information , in relation to a registered trade name product or group of registered trade name products, includes, but is not limited to,— a information not previously considered by the Director-General during an assessment of the registered trade name product or group; and b information indicating that conditions placed on the trade name product or group in accordance with section 23 do not adequately manage the risks associated with that trade name product or group. 32 Section 30 repealed (Reassessment of provisional registration) Repeal section 30. 33 Section 30A amended (Suspension of registration) Replace section 30A(1) with: 1 The Director-General may suspend the registration of a registered trade name product, for a period of up to 3 months, if the Director-General has reasonable grounds to believe that— a a condition imposed on the registered trade name product is not being complied with; or b the registered trade name product poses a risk to public health, trade in primary produce, animal welfare, or agricultural security. Replace section 30A(3) and (4) with: 3 The effect of a suspension of registration under this section is that no person may import, manufacture, sell, or use the relevant trade name product during the period of suspension, except as authorised by the Director-General and subject to any condition or requirement imposed under subsection (2). 4 If satisfied that it is necessary in the circumstances, the Director-General may extend the period of suspension once for a further period not exceeding 3 months that the Director-General notifies to the registrant in writing before the original suspension expires. Replace section 30A(5) with: 5 The Director-General must publicly notify any suspension or extension of a suspension under this section ( see section 82 ). Replace section 30A(8) with: 8 If a person acting under the delegated authority of the Director-General suspends or extends the suspension of any registration under this section, the registrant may seek a review of the suspension or extension (as the case may be) under section 85 . Repeal section 30A(9). 34 New section 30B inserted (Provisions to be complied with before suspension or extension) After section 30A, insert: 30B Provisions to be complied with before suspension or extension 1 Before suspending or extending the suspension of a registration under section 30A, the Director-General must— a notify the registrant in writing of the proposed suspension or extension and the reasons for it and, in the case of a proposed suspension,— i the date on which or the time at which it is proposed to commence (being no earlier than the date or time of notification); and ii any conditions or requirements proposed to be imposed in relation to the suspension; and b give the registrant a reasonable opportunity to be heard. 2 The Director-General is not required to give the registrant an opportunity to be heard before suspending or extending the suspension of a registration if— a the Director-General is satisfied that the suspension or extension is required to respond to an emergency involving a risk to public health, trade in primary produce, animal welfare, or agricultural security; and b the written notice states that it is required to respond to an emergency of that kind. 3 However, the registrant must be given a reasonable opportunity to be heard as soon as practicable after the suspension or extension commences. 35 Sections 31 and 32 repealed Repeal sections 31 and 32. 36 Section 32A amended (Cancellation of registration) In section 32A(6), replace 77A with 85 . Replace section 32A(7)(b) with: b any application for review must be provided to the Director-General under section 85(3) within 20 working days after the date on which the trade name product’s removal from the register is first publicly notified ( see section 82 ). 37 Section 33 amended, renumbered as section 84, and repositioned (No compensation or damages for loss arising from certain changes) Repeal section 33(b). In section 33(c), delete or 30 . After section 33(e), insert: ea the reassessment of a consent under section 35AAH ; or eb the suspension of a consent under section 35AAI ; or ec the cancellation of a consent under section 35AAK ; or Replace section 33(f) with: f the revocation under section 57 of any of the following: i an approval of an agricultural compound under section 8C: ii the registration of a trade name product: iii a consent under section 35AAD in respect of an agricultural compound; or Renumber section 33 as section 84 and reposition it after section 83 (as renumbered and repositioned by section 29 of this Act). 38 Section 34 amended (Transfer and surrender of registration) Replace section 34(1) with: 1 The registration of a trade name product— a may be transferred by the registrant to any other person; or b may be surrendered by a registrant. In section 34(2), replace subsection (1)(a) with this section . 39 Section 35 amended (Rights of registrant) Repeal section 35(2). 40 New sections 35AA to 35AAP and cross-headings inserted After section 35, insert: Consent to import, etc and use agricultural compounds for research and other purposes 35AA Application Making of application 1 A person may apply to the Director-General for consent— a to import, manufacture, or sell an agricultural compound to enable it to be used— i for the purpose of obtaining further information on it to decide whether it should be registered as a trade name product under section 21; or ii in research for a purpose other than the registration of the compound as a trade name product under section 21; and b to use the agricultural compound for the purpose of obtaining that further information or in that research. 2 An application may not be made under this section in relation to any agricultural compound that is— a a substance, mixture of substances, or biological compound prohibited from use as an agricultural compound, or prohibited from use as an ingredient in an agricultural compound, in accordance with the regulations; or b exempt under section 8AA or 8A. Approved form and information for application 3 The application must be in the approved form and contain, or be accompanied by, the approved information. 4 Without limiting the approved information that the applicant may be required to supply, the applicant may be required to supply information obtained from a person belonging to a particular class, including, for example, from— a a recognised agency or a recognised person; or b a person who meets specified criteria (including, for example, particular qualifications or skills). Additional information to assess application 5 If, in the opinion of the Director-General, information additional to that provided under subsection (3) is required to assess the application, the Director-General may— a request the applicant to provide any additional information that the Director-General specifies in writing; and b with the permission of the applicant, request that any other person supply any additional information that the Director-General specifies in writing. 6 For the purpose of verifying any information supplied to the Director-General under any of subsections (3) to (5) , the Director-General may request any person to provide additional information (other than information protected by section 74A) that the Director-General specifies in writing. 35AAB Notification of application 1 On receiving an application under section 35AA , the Director-General must notify the Environmental Protection Authority established by section 7 of the Environmental Protection Authority Act 2011. 2 The notice must include information on the nature and proposed use of the agricultural compound. 3 The Director-General must supply further information to any person notified under this section, if requested by that person, unless that information is protected in accordance with section 74A. 4 The Director-General may waive the requirement to notify an application under this section if there is a registered trade name product with the same active ingredients as, and an equivalent formulation to, the agricultural compound that is the subject of the application. 35AAC Period within which application to be decided The Director-General must decide the application within any period determined in accordance with the regulations. Guidance note See section 35AAO in relation to the variation of time limits under this Act. 35AAD Decision on application 1 In considering an application made under section 35AA , the Director-General must identify the risks likely to arise from the proposed use of the agricultural compound concerned if the Director-General grants the consent. 2 The Director-General must grant the application if the Director-General is satisfied that the risks likely to arise from the proposed use of the agricultural compound can be adequately managed by imposing conditions on the consent that ensure that— a neither of the following is sold, released, or used in any way for purposes other than those for which the consent is granted: i the agricultural compound: ii any animal, plant, or primary produce to which the compound has been applied or that has been exposed to it; and b the agricultural compound and any animal, plant, or primary produce referred to in paragraph (a) is disposed of in a way that minimises the risks. 3 However, the Director-General must not grant the application if— a the agricultural compound is also a hazardous substance or new organism; and b an approval for that substance or organism has not been issued under the Hazardous Substances and New Organisms Act 1996. 4 In granting a consent under this section, the Director-General may impose any conditions on the consent that the Director-General is satisfied are necessary— a to achieve the purposes of the consent; and b to manage any risks likely to arise from the proposed use of the agricultural compound. 5 In this section, risks , in relation to an agricultural compound, means any of the following: a risks to public health: b risks to trade and market access for primary produce arising from the use of the agricultural compound: c risks to agricultural security: d risks to the welfare of animals that result from treatment with or exposure to the agricultural compound: e risks to domestic food residue standards. 35AAE Duration of consent 1 A consent is in force for the period starting on the date on which consent is given and ending on the date specified in the consent. 2 That period— a must be a period that the Director-General is satisfied is sufficient only to achieve the purposes of the consent; and b may be extended by the Director-General, and the date specified in the consent amended accordingly, if the Director-General is satisfied that an extension is necessary to achieve the purposes of the consent. 3 Despite subsection (1) , a consent ceases to be in force— a at the close of the day on which it is reassessed in accordance with section 35AAH and declined; or b when it is cancelled under section 35AAK ; or c when it is surrendered under section 35AAL ; or d when it is revoked under section 57. 4 As soon as practicable after a consent ceases to be in force under this section, the agricultural compound to which it applied must be disposed of in accordance with any applicable conditions imposed on the consent. 5 For that purpose only, the consent is to be treated as continuing in force. 35AAF Conditions relating to approved specifications 1 The conditions that may be imposed on a consent include those that require any 1 or more of the following matters to be in accordance with specifications approved by the Director-General under section 35AAG : a labelling or advertising of the agricultural compound: b manufacturing of the agricultural compound: c how, the location at which, or how much of the agricultural compound is used: d characteristics of the agricultural compound (including, for example, its formulation, purity, shelf life, packaging, and use). 2 This section does not limit section 35AAD(4) . 35AAG Approval and variation of specifications 1 The Director-General may approve specifications for the purposes of any condition of a kind referred to in section 35AAF that is to be imposed on a consent. 2 The person to whom the consent is granted may apply to the Director-General to vary any of those specifications. 3 The application must be in the approved form and contain, or be accompanied by, the approved information. 4 Without limiting the approved information that the applicant may be required to supply, the applicant may be required to supply information obtained from a person belonging to a particular class, including, for example, from— a a recognised agency or a recognised person; or b a person who meets specified criteria (including, for example, particular qualifications or skills). 5 The Director-General must decide the application in accordance with the regulations. 35AAH Reassessment of consent 1 The Director-General may, after consultation with the person to whom a consent has been granted (the consent holder ), decide to reassess the agricultural compound to which a consent applies if, in the opinion of the Director-General, significant new information on the agricultural compound has become available. 2 The Director-General’s decision to reassess the agricultural compound must be notified to the consent holder. 3 The Director-General’s decision to reassess the agricultural compound is to be treated as a new application for a consent in respect of the agricultural compound, and sections 35AA to 35AAE apply with any necessary modifications. 4 Part 6 applies to the application— a as if it were a non-innovative application made under section 35AA ; and b with any necessary modifications. 5 The Director-General may, if the Director-General thinks fit,— a prohibit or restrict the importation, manufacture, sale, or use of the agricultural compound until a decision is made under section 35AAD (as applied by subsection (3) ); and b publicly notify the prohibition or restriction. 6 In this section,— agricultural compound , in relation to a consent, includes a group of agricultural compounds to which 1 or more consents apply and that have the same active ingredients and similar formulations new information , in relation to an agricultural compound, includes, for example,— a information not previously considered by the Director-General during an assessment of the agricultural compound; and b information indicating that conditions imposed on the consent do not adequately manage the risks arising from the use of the agricultural compound risks , in relation to an agricultural compound, has the same meaning as in section 35AAD . 35AAI Suspension of consent 1 The Director-General may suspend a consent in respect of an agricultural compound, for a period of up to 3 months, if the Director-General has reasonable grounds to believe that— a a condition imposed on the consent is not being complied with; or b the agricultural compound poses a risk to public health, trade in primary produce, animal welfare, or agricultural security. 2 The Director-General may impose conditions and requirements in relation to the implementation and operation of a suspension under this section. 3 The effect of a suspension of consent under this section is that no person may import, manufacture, sell, or use the agricultural compound during the period of suspension, except as authorised by the Director-General and subject to any condition or requirement imposed under subsection (2) . 4 If satisfied that it is necessary in the circumstances, the Director-General may extend the period of suspension once for a further period not exceeding 3 months that the Director-General notifies to the consent holder in writing before the original suspension expires. 5 A suspension under this section does not affect any other actions that the Director-General or an ACVM officer may take under this Act. 6 If a consent is suspended under this section, the Director-General— a may direct the consent holder to take action appropriate to deal with any affected agricultural compound; and b may exercise any other powers conferred on the Director-General under this Act. 7 If a person acting under the delegated authority of the Director-General suspends or extends the suspension of any consent under this section, the consent holder may seek a review of the suspension or extension (as the case may be) under section 85 . 35AAJ Provisions to be complied with before suspension or extension of suspension 1 Before suspending or extending the suspension of a consent under section 35AAI , the Director-General must— a notify the consent holder in writing of the proposed suspension or extension and the reasons for it and, in the case of a proposed suspension,— i the date on which or the time at which it is proposed to commence (being no earlier than the date or time of notification); and ii any conditions or requirements proposed to be imposed in relation to the suspension; and b give the consent holder a reasonable opportunity to be heard. 2 The Director-General is not required to give the consent holder an opportunity to be heard before suspending or extending the suspension of a consent if the Director-General is satisfied that, and the written notice states that, the suspension or extension is required to respond to an emergency involving a risk to public health, trade in primary produce, animal welfare, or agricultural security. 3 However, the consent holder must be given a reasonable opportunity to be heard as soon as practicable after the suspension or extension commences. 35AAK Cancellation of consent 1 The Director-General may cancel a consent in respect of an agricultural compound if satisfied that the risks arising from the use of the agricultural compound are not being adequately managed. 2 In this section, risks , in relation to an agricultural compound, has the same meaning as in section 35AAD . 35AAL Surrender of consent A consent in respect of an agricultural compound may be surrendered by the person to whom the consent is granted. Exemption, registration, or consent: other 35AAM No implied warranty An exemption of any agricultural compound from registration under section 8AA or 8A, the registration of any trade name product under section 21, or a consent under section 35AAD in respect of any agricultural compound does not imply a warranty by the Crown or the Director-General that the agricultural compound or trade name product— a is reasonably fit for the purpose for which it is sold; or b complies with any labelling or other consumer information relating to that compound or product. 35AAN Waivers and directions relating to supply of information The Director-General may, on the application of a person,— a waive a requirement as to the information that the person must supply under this subpart; or b give a direction as to the terms on which the person must supply information under this subpart. 35AAO Variation of time limits 1 The Director-General may, on the application of a person, vary a time limit imposed under this subpart. 2 The Minister may vary any time limit imposed under this subpart whether or not an application has been made under this section in relation to the time limit or that time limit has expired. 3 In any case, the Minister must be satisfied that the matter to which the time limit applies will be carried out as promptly as is reasonable in the circumstances. 4 The Director-General or the Minister may vary the closing date by which submissions made in response to public notification under section 14 or 20A must be received only if satisfied that the specified persons— a have consented to the variation; or b have not consented to, but would not be unduly prejudiced by, the variation. 5 The specified persons are,— a in any case, any persons who the Director-General or the Minister, as the case may be,— i is aware have made a submission in response to the public notification; or ii is satisfied are likely to make a submission in response to the public notification; or b in the case of the variation of a closing date under section 14,— i the applicant for the application under section 9 that is required to be publicly notified under section 14; or ii the registrant in the case of a decision under section 29 that is required to be publicly notified under section 14. 35AAP Requests under Official Information Act 1982 involving trade secrets, etc 1 This section applies if— a the Director-General receives a request under the Official Information Act 1982 to release any information held by the Director-General in respect of an application under this subpart (other than information to which Part 6 applies); and b the information to which the request relates,— i in the Director-General’s opinion, may be able to be withheld under section 9(2)(b) of the Official Information Act 1982; or ii has been classified as commercially sensitive by the person who gave the information to the Director-General (the information-giver ). 2 The Director-General must make all reasonable efforts to, as soon as practicable, notify the information-giver that the Director-General has received a request to release the information. 3 Within 10 working days after a person receives a notice under this section, the person must respond to the Director-General by— a stating whether the person believes that the information should be withheld under section 9(2)(b) of the Official Information Act 1982; and b giving reasons for that belief. 4 The Director-General may, in accordance with the Official Information Act 1982, release the information or withhold the information if— a the Director-General has complied with subsection (2) ; and b the time limit applying under subsection (3) to the person receiving a notice has expired. 41 Cross-heading above section 35A replaced Replace the cross-heading above section 35A with: 3 Certifying compliance of agricultural compounds with Act 42 New subpart 4 of Part 2 inserted After section 35F, insert: 4 Manufacturing practice standards Specification and application of manufacturing practice standards 35FA Specification of standards 1 The Director-General may, by notice, specify standards ( manufacturing practice standards ) that apply to manufacturing agricultural compounds in New Zealand. 2 The manufacturing practice standards may relate to 1 or more of the following: a the standards to be maintained, and the plant and equipment to be used, at premises used for manufacturing agricultural compounds: b procedures for quality assurance and quality control to be applied in manufacturing agricultural compounds: c the people engaged in manufacturing agricultural compounds, including (for example) the qualifications, training, and experience required of those people: d the manufacturing practices to be applied in manufacturing agricultural compounds: e procedures relating to complaints about, and the tracing and recall of, agricultural compounds: f records to be kept in connection with the manufacture of, sale of, complaints about, and tracing and recall of, agricultural compounds and the periods for which those records are to be kept: g audits, and other checks, of compliance with the manufacturing practice standards that relate to 1 or more of the matters set out in the other paragraphs of this subsection: h other matters relating to— i the prevention and management of the risks referred to in section 4(a); or ii the quality and efficacy of agricultural compounds that are manufactured in New Zealand. 3 A manufacturing practice standard may apply to— a all agricultural compounds; or b a class of agricultural compounds; or c particular agricultural compounds. 4 A notice under this section is secondary legislation ( see Part 3 of the Legislation Act 2019 for publication requirements). 35FB Certain manufacturers required to comply with manufacturing practice standards A manufacturer of an agricultural compound must comply with the manufacturing practice standards, and ensure that the people engaged in manufacturing the agricultural compound for the manufacturer comply with those standards, to the extent required by a condition of— a registration of the agricultural compound as a trade name product; or b a consent under section 35AAD in respect of the agricultural compound; or c an exemption from the requirement to register the agricultural compound. Certifying compliance with manufacturing practice standards 35FC Meaning of certificate of compliance: sections 35FD to 35FF For the purposes of sections 35FD to 35FF , a certificate of compliance is a certificate attesting that the manufacturer of specified agricultural compounds, or a specified class of agricultural compounds,— a has complied with any manufacturing practice standards specified in the certificate; and b has ensured that the people engaged in manufacturing the agricultural compounds, or compounds of the specified class, for the manufacturer have complied with any manufacturing practice standards specified in the certificate. 35FD Application and issue of certificate of compliance General 1 The Director-General may issue a certificate of compliance on— a an application made in the approved form and containing, or accompanied by, the approved information; and b payment of the fee prescribed by the regulations. Additional information to assess application 2 If, in the opinion of the Director-General, information additional to the relevant information is required to assess the application, the Director-General may— a request the applicant to provide any additional information that the Director-General specifies in writing; and b with the permission of the applicant, request any other person to supply any additional information that the Director-General specifies in writing. 3 The relevant information is— a the approved information that is required to be contained in, or to accompany, the application; and b the results of any audit or other checks ( see section 35FA(2)(g) ). Matters to be taken into account 4 In deciding whether to issue a certificate of compliance, the Director-General may take into account any matters that the Director-General considers relevant, including the results of any audit or other checks. Other 5 A certificate of compliance may be issued in respect of the manufacture of an agricultural compound, or an agricultural compound of a specified class, whether or not the manufacturer is required to comply with the specified manufacturing practice standards as referred to in section 35FB . Guidance note For example, the agricultural compounds may not be required by section 8 to be registered, approved, or exempted as referred to in section 35FB and may be manufactured for export only ( see section 8(2)(a)(iii) ). 6 A certificate of compliance must be in the approved form. 7 A certificate of compliance may be communicated to its appropriate destination by writing, electronic means, or any other form of communication that is accurate, clear, and verifiable. 35FE Withdrawal and reissue of certificate of compliance 1 A certificate of compliance may be withdrawn by the Director-General if the Director-General is satisfied that— a the certificate was incorrectly or inappropriately given; or b events or circumstances occurring since the certificate was issued mean that it no longer holds true or is misleading. 2 The Director-General may reissue a withdrawn certificate of compliance as a new certificate of compliance (with modifications, if appropriate) on— a an application made in the approved form and containing, or accompanied by, the approved information; and b payment of the fee prescribed by the regulations. 3 Section 35FD(2) applies in relation to the decision of the Director-General about whether to reissue a certificate of compliance. 35FF No Crown liability The Crown, the Director-General, and employees of the Ministry are not liable, by reason of the issue, refusal or failure to issue, or withdrawal of a certificate of compliance in respect of the manufacture of any agricultural compound, for any loss arising through the refusal or failure of the relevant authority of an overseas market to admit an agricultural compound intended to be exported to that market. 43 Cross-heading above section 35G replaced Replace the cross-heading above section 35G with: 5 Recall of agricultural compounds 44 Section 39 amended (Minister’s power to call in applications with significant effects) In section 39(1), replace this Act (other than an application for approval under section 8C or for a certificate of compliance under section 35C) with section 9 or 35AA . 45 Section 42 amended (Investigation by Board of Inquiry) In section 42(1)(a), after 14 , insert (including if the application is made under section 35AA ) . In section 42(1)(b), after 11 , insert or 35AA(5) or (6) (as applicable) . Replace section 42(1)(c) and (d) with: c must investigate an application made under section 9(1) having regard to all relevant matters, including matters under sections 19, 20, and 21 and the Minister’s reasons for giving the direction under section 39; and d must investigate an application made under section 9(2) having regard to all relevant matters, including matters under section 21A and the Minister’s reasons for giving the direction under section 39; and e must investigate an application made under section 35AA having regard to all relevant matters, including matters under section 35AAD and the Minister’s reasons for giving the direction under section 39. Replace section 42(2) and (3) with: 2 Sections 17 to 20, 21, 22, and 23 apply with all necessary modifications to an inquiry into an application made under section 9(1) as if the conduct of the inquiry were the consideration of that application. 3 Sections 17 to 20 and 21A apply with all necessary modifications to an inquiry into an application made under section 9(2) as if the conduct of the inquiry were the consideration of that application. 4 Section 35AAD applies with all necessary modifications to an inquiry into an application made under section 35AA as if the conduct of the inquiry were the consideration of that application. 46 Section 44 amended (Minister to decide application and notify decision) In section 44(3), replace section 27 with 35AAD . 47 Section 44K amended (Proposal to refuse application to recognise agency, person, or class of persons) In section 44K(3)(b), replace 77A with 85 . 48 Section 44L amended (Proposal to exclude members, or categories of members, from recognition of class) In section 44L(3)(b), replace 77A with 85 . 49 Section 44M amended (Director-General may impose or vary conditions of recognition) In section 44M(4), replace 77A with 85 . 50 Section 44ZA amended (Method of suspension of recognition) In section 44ZA(2)(d), replace 77A with 85 . Replace section 44ZA(3) with: 3 The Director-General may publicly notify any suspension of recognition ( see section 82 ). 51 Section 44ZE amended (Method of withdrawal of recognition) In section 44ZE(2)(d), replace 77A with 85 . Replace section 44ZE(3) with: 3 The Director-General may publicly notify any withdrawal of recognition ( see section 82 ). 52 Section 46 amended (Appeal on question of law) In section 46(1)(a), replace sections 9 and 26 with section 9 . After section 46(1)(a), insert: aa party to an application for a consent under section 35AA ; or 53 Section 55 amended (Offences) In section 55(1)(c), delete or section 27 . In section 55(1)(d), replace by regulations made under section 75 with under section 8AA . After section 55(1)(d), insert: daa knowingly contravenes any conditions of a consent granted under section 35AAD ; or After section 55(1)(dd), insert: dda knowingly imports, manufactures, sells, or uses a product while that product’s registration is suspended under section 35AAI , unless allowed to do so by a condition or requirement imposed under section 35AAI(2) ; or ddb knowingly contravenes or fails to comply with a condition or requirement imposed under section 35AAI(2) ; or ddc knowingly fails to comply with a direction given under section 35AAI(6) ; or Replace section 55(1)(f) with: f knowingly makes a false representation that any agricultural compound— i is registered as a trade name product in accordance with section 21; or ii is the subject of a consent under section 35AAD ; or iii is exempt from registration under section 8AA ; or 54 Section 57 amended (Revocation of registration or approval) In the heading to section 57, replace or approval with , approval, or consent . In section 57(2), after 8C , insert or a consent under section 35AAD . In section 57(2), after the approval , insert or consent . 55 Part 6 heading amended In the Part 6 heading, replace about trade name products with supporting certain applications . 56 Section 72 amended (Interpretation) In section 72(1), insert in their appropriate alphabetical order: innovative application means a TNP application, or a section 35AA application, relating to a trade name product or an agricultural compound to which the following apply: a the ingredient is referred to in the application as an active ingredient of the trade name product or agricultural compound; and b at the time when the Director-General receives the application, the ingredient has not previously been an active ingredient of— i a trade name product registered under section 21; or ii a pesticide that was registered under the Pesticides Act 1979 before its repeal by the Hazardous Substances and New Organisms Act 1996; or iii an animal remedy the manufacture or importation of which was licensed (otherwise than by a provisional licence) under the Animal Remedies Act 1967 before its repeal by this Act non-innovative application means a section 35AA application, or a TNP application, that is not an innovative application section 35AA application means an application under section 35AA for a consent relating to an agricultural compound TNP application means an application under section 9(1) to register a trade name product In section 72(1), repeal the definitions of innovative TNP application and non-innovative TNP application . In section 72(1), definitions of innovative trade name product and non-innovative trade name product , delete TNP . In section 72(2), delete TNP . 57 Section 73 amended (Meaning of confidential information) In section 73(1)(a), delete TNP in each place. In section 73(1)(b), after trade name product , insert or agricultural compound . 58 Section 74 amended (Meaning of protected period) In section 74(a) and (d), delete TNP . In section 74(b), replace innovative TNP application made under section 26 with innovative application made under section 35AA . In section 74(e), replace non-innovative TNP application made under section 26 with non-innovative application made under section 35AA . 59 Section 74A amended (Director-General must protect confidential information during protected period) In section 74A(1)(b), delete TNP in each place. 60 Cross-heading above section 74B amended In the cross-heading above section 74B, after products , insert or agricultural compounds . 61 Section 74B amended (Innovative TNP application for full registration) Replace the heading to section 74B with Innovative application for registration . In section 74B(1), delete TNP . 62 Section 74C amended (Innovative TNP application for provisional registration) Replace the heading to section 74C with Innovative application for consent under section 35AA . In section 74C(1), replace innovative TNP application under section 26 with innovative application under section 35AA . In section 74C(3), delete TNP . In section 74C(3)(a), replace for the same trade name product with for registration of the same agricultural compound as a trade name product . In section 74C(3)(b), replace section 26 with section 35AA . 63 Section 74D amended (Application to authorise new use or method of use) In section 74D(2)(a), delete TNP . 64 Cross-heading above section 74E amended In the cross-heading above section 74E, after products , insert or agricultural compounds . 65 Section 74E amended (Non-innovative TNP application for full registration) Replace the heading to section 74E with Non-innovative application for registration . In section 74E(1), delete TNP . 66 Section 74F amended (Non-innovative TNP application for provisional registration) Replace the heading to section 74F with Non-innovative application for consent under section 35AA . In section 74F(1), replace non-innovative TNP application under section 26 with non-innovative application under section 35AA . In section 74F(3), delete TNP . In section 74F(3)(a), replace for the same trade name product with for registration as a trade name product of the same agricultural compound . In section 74F(3)(b), replace section 26 with section 35AA . 67 Section 74H amended (Director-General may disclose or use confidential information) In section 74H(1), delete TNP in each place. 68 New subpart 1 heading in Part 7 inserted After the Part 7 heading, insert: 1 Regulations and other secondary legislation 69 Section 75 amended (Regulations) Repeal section 75(1)(a) and (c). Replace section 75(1)(ca) with: ca prescribing procedures, processes, and requirements relating to conditions imposed at the time of— i registration of trade name products under section 21; or ii granting consents under section 35AAD in respect of agricultural compounds: In section 75(1)(cb), delete as an agricultural compound . Replace section 75(1)(cc) with: cc prescribing procedures, processes, and requirements for applying for— i registration of a trade name product under section 21; or ii variation of the conditions on a registered trade name product; or iii consent under section 35AAD in respect of an agricultural compound: In section 75(1)(he)(i), after registration , insert , consent, . 70 Sections 76 and 77 repealed Repeal sections 76 and 77. 71 Section 77A amended, renumbered as section 85, and repositioned (Right of review of decisions made under delegated authority) In section 77A(1)(b), after 21 , insert or 21A . Repeal section 77A(1)(c). After section 77A(1)(e), insert: ea a decision made under section 35AAD : eb a decision to suspend a consent under section 35AAI : ec a decision to cancel a consent under section 35AAK : Renumber section 77A as section 85 and reposition it after section 84 (as renumbered and repositioned by section 36 of this Act). 72 Sections 79 and 80 renumbered as sections 86 and 87 and repositioned Renumber sections 79 and 80 as sections 86 and 87 , respectively, and reposition them after section 85 (as renumbered and repositioned by section 70 of this Act). 73 Cross-heading above section 81 replaced Replace the cross-heading above section 81 with: 2 Cost recovery 74 Section 81J amended (Penalties for failure to pay fee, levy, or charge) In section 81J(2)(b), after certificate of compliance , insert issued under subpart 3 or 4 of Part 2 . 75 New subpart 3 of Part 7 inserted After section 81K, insert: 3 Other 82 Method of public notification 1 If any matter is required to be publicly notified under this Act, it must be notified in 1 or more of the following ways: a by notice in the Gazette : b by publication in all major metropolitan daily newspapers on at least 2 occasions: c by publication, either temporarily or permanently, on the Ministry’s Internet site: d in any other way that the Director-General is reasonably satisfied will ensure that the matter is sufficiently notified to members of the public. 2 In deciding which methods of notification are most appropriate in any particular case, the Director-General must consider— a the nature and significance of the matter required to be publicly notified; and b the desirability of ensuring that the matter is brought to the attention of people likely to have an interest in the matter. 76 Sections 85 and 86 and cross-heading repealed Repeal sections 85 and 86 and the cross-heading above section 85. 77 Schedule 1 amended In Schedule 1,— a insert the Part set out in Schedule 1 of this Act as the last Part; and b make all necessary consequential amendments. 78 Consequential amendments related to Part 1 Amend the legislation specified in Schedule 2 as set out in that schedule. 1 New Part 2 inserted into Schedule 1 2 Provisions relating to Agricultural Compounds and Veterinary Medicines Amendment Act 2026 Interpretation 4 Interpretation 1 In this Part,— 2011 regulations means the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 amendment Act means the Agricultural Compounds and Veterinary Medicines Amendment Act 2026 . 2 In this Part,— a a reference to a new provision is a reference to the provision as inserted or replaced by the amendment Act; and b a reference to an old provision is a reference to the provision as in force immediately before it was repealed or replaced by the amendment Act. Exemptions 5 Expiry of clauses 6 and 8 Clauses 6 and 8 expire on the earlier of the following dates: a 30 June 2029: b the date on which regulations 5 and 6 of the 2011 regulations are revoked by regulations made under section 75. 6 Exemptions in regulations continued 1 Regulations 5 and 6 of the 2011 regulations— a continue in force until the expiry of this clause; and b are revoked when this clause expires. 2 However, any of regulations 5 and 6 and Schedule 2 of the 2011 regulations may be amended or revoked (by regulations made under section 75) at any time before they would otherwise be revoked by this clause. 3 An agricultural compound that, immediately before old section 8A(1)(a) is repealed by the amendment Act, is exempt from registration under the 2011 regulations is to be treated as exempt from registration under new section 8AA (subject to any conditions and requirements applying under the 2011 regulations). 4 Subclause (3) does not apply to an agricultural compound that ceases to be exempt from registration under the 2011 regulations. 5 Until the expiry of this clause, old section 24(4) continues to apply in relation to an agricultural compound that is to be treated as exempt from registration under subclause (3) . 7 Certain conditions in 2011 regulations continued 1 On and from the commencement of new section 8AA , the conditions set out in regulations 7 to 13 of the 2011 regulations, as in force immediately before that commencement, are to be treated as being prescribed for the purposes of new section 8AA(2)(a) . 2 However, nothing prevents any of those regulations from being amended or revoked at any time on or after that commencement. 8 Preconditions to granting exemption switched off 1 The Director-General may grant an exemption under new section 8AA that— a applies to any agricultural compound or class of agricultural compounds that is exempt from registration under that section because of clause 6 ; and b specifies conditions that have the same effect as, or a similar effect to, all or any of the conditions and requirements applying to the compound or class of compounds under the 2011 regulations. 2 The Director-General is not required to comply with the preconditions set out in new section 8AA(4) and (5) before granting an exemption under subclause (1) . 3 Subclause (2) ceases to apply in relation to an agricultural compound or a class of agricultural compounds when an exemption under subclause (1) that applies to the agricultural compound or class of agricultural compounds commences. 4 If an agricultural compound or a class of agricultural compounds ceases to be the subject of an exemption granted by the Director-General under subclause (1) , the authority conferred by subclause (2) is not revived. Registrations other than provisional registrations 9 Existing applications for registration 1 This clause applies to an application for registration of a trade name product under section 21 that is made, but is not finally decided, before new section 16 commences. 2 Each of the following is to be done in accordance with this Act as in force immediately before new section 16 commences: a the giving of any waiver relating to the notification of the application: b the giving of any waiver or extension of, or any direction concerning, the time or time period by or within which any action relating to the application must be carried out: c the giving of any waiver or any direction concerning— i information that must be supplied in connection with the application; or ii the terms on which that information must be supplied. 3 The application is to be notified (if required) and decided, and the decision is to be notified, in accordance with this Act as in force immediately before new section 16 commences. 4 However, if the Director-General proposes to grant the application and register the trade name product on or after the specified commencement,— a the Director-General may approve specifications under new section 23A(1) for the purposes of a condition to be imposed under any of section 23(1)(d) (as amended by the amendment Act) and new section 23(1)(la) and (lb) on the registration; and b the Director-General may register the trade name product with the condition. 5 This clause does not limit clause 14 (applications for registration that are called in by the Minister). 6 In this clause, specified commencement means the commencement of each of the following: a new section 23A(1) : b the amendment of section 23(1)(d) by the amendment Act: c new section 23(1)(la) and (lb) . 10 Application for variation of conditions 1 This clause applies to an application for the variation of 1 or more of the conditions on a registered trade name product that is made, but is not finally decided, before new section 16 and new section 21A commence. 2 Each of the following matters is to be done in accordance with this Act as in force immediately before new section 16 commences: a the giving of any waiver relating to the notification of the application: b the giving of any waiver or extension of, or any direction concerning, the time or time period by or within which any action relating to the application must be carried out: c the giving of any waiver or any direction concerning— i information that must be supplied in connection with the application; or ii the terms on which that information must be supplied. 3 The application is to be notified (if required) and decided, and the decision is to be notified, in accordance with this Act as in force immediately before new section 16 commences. 4 New section 21A does not apply in relation to the application. 5 This clause does not limit clause 14 (applications for registration that are called in by the Minister). 6 In this clause, registered trade name product means a trade name product that is registered under section 21. 11 Approved product and manufacturing specifications 1 This clause applies to any condition— a that is imposed, in accordance with section 23 or 44, on a trade name product’s registration before the specified commencement; and b that requires the labelling or manufacturing of the product or any other matter relating to the product to comply with the product and manufacturing specifications approved as part of the product’s registration. 2 The condition is to be treated as being imposed under whichever of the conditions referred to in section 23(1)(d) (as amended by the amendment Act) and new section 23(1)(la) or (lb) most closely corresponds to the condition. 3 For that purpose, a reference in the condition to the product and manufacturing specifications approved as part of the product’s registration is to be treated as a reference to specifications approved by the Director-General under new section 23A . 4 New section 23A applies in relation to the variation of those specifications. 5 In this clause, specified commencement has the same meaning as in clause 9 . 12 Reassessment of trade name products 1 This clause applies to a decision under section 29(1) that— a is deemed under section 29(3) to be a new application for registration of a trade name product; and b is made, but is not finally decided, before the commencement of the amendments made to section 29(3) by the amendment Act. 2 Section 29(3), as in force before that commencement, continues to apply in relation to the deemed application. 3 However, if the Director-General proposes to grant the application and register the trade name product on or after the specified commencement, the Director-General may— a approve specifications under new section 23A(1) for the purposes of a condition to be imposed under any of section 23(1)(d) (as amended by the amendment Act) and new section 23(1)(la) and (lb) on the registration; and b register the trade name product with the condition. 4 In this clause, specified commencement has the same meaning as in clause 9 . 13 Extension of suspension of registration Requirement for public notification 1 New section 30A(5) does not apply in relation to the extension, before that new provision commences, of a suspension of a trade name product (even if the extended suspension is in force when that new provision commences). Provisions to be complied with before extension 2 New section 30B applies in relation to any extension, on or after that new section commences, of a suspension of a trade name product (even if the original suspension is in force before that new section commences). 14 Applications for registration that are called in by Minister 1 This clause applies to an application for registration of a trade name product under section 21 that— a is made, but is not finally decided, before section 42 is amended by the amendment Act; and b is the subject of a direction under section 39 made before or after the commencement of those amendments. 2 This Act, as in force immediately before section 42 is amended by the amendment Act, continues to apply in relation to the application. 3 However, if the Minister proposes to grant the application and register the trade name product on or after the specified commencement,— a the Director-General may approve specifications under new section 23A(1) for the purposes of a condition to be imposed under any of section 23(1)(d) (as amended by the amendment Act) and new section 23(1)(la) and (lb) on the registration; and b the Minister may register the trade name product with the condition. 4 This clause does not affect the treatment of a decision under section 44 as a decision by the Director-General ( see section 44(3)). 5 In this clause, specified commencement has the same meaning as in clause 9 . 15 Application for variation of conditions 1 This clause applies to an application for the variation of 1 or more of the conditions on a registered trade name product that— a is made, but is not finally decided, before section 42 is amended by the amendment Act; and b is the subject of a direction under section 39 before or after the commencement of those amendments. 2 This Act, as in force immediately before section 42 is amended by the amendment Act, continues to apply in relation to the application. 3 In this clause, registered trade name product means a trade name product that is registered under section 21. Provisional registrations 16 Application for provisional registration 1 An application for registration of a trade name product under old section 27 that is made, but is not finally decided, before the repeal of that section is to be decided under this Act as in force immediately before that repeal. 2 If the application is granted, this Act, as in force immediately before the repeal of old section 27, applies in relation to— a the trade name product; and b the trade name product’s provisional registration. 17 Saving of provisional registrations and old law This Act, as in force immediately before the repeal of old section 27, continues to apply in relation to— a a trade name product that is provisionally registered immediately before that repeal; and b the trade name product’s provisional registration. 18 Director-General may approve operating plans 1 This clause applies if an approved operating plan is required as a condition of the registration of a trade name product that is referred to in clause 16(2) or 17 . 2 The Director-General may— a approve the operating plan (whether it is submitted before or after the commencement of the amendments made to section 28 by the amendment Act); or b amend or revoke any approval of an operating plan (following consultation with the person whose operating plan it is) that is approved under— i paragraph (a) ; or ii old section 28(2). Protection of confidential information, etc 19 Requests under Official Information Act 1982 involving trade secrets, etc 1 A reference in new section 35AAP(1)(a) to an application under subpart 2 of Part 2 includes a reference to a relevant application that is made before new section 35AAP commences. 2 In this section, relevant application means— a an application for an exemption under section 8C; or b an application for registration of a trade name product under section 21; or c an application for registration of a trade name product under old section 27; or d a decision under section 29(1) that is deemed under section 29(3) to be a new application for a trade name product. 20 Confidential information supporting old section 26 applications: unamended Part 6 continues to protect 1 This clause applies to any information received by the Director-General that— a is provided in support of an innovative TNP application or a non-innovative TNP application made under old section 26; and b is confidential information (within the meaning of section 73(2)) about the trade name product that is the subject of that application. 2 Part 6, as in force immediately before it is amended by the amendment Act, continues to apply in relation to any information to which this clause applies. 3 In this clause, innovative TNP application and non-innovative TNP application have the same meanings as in section 72(1) (as in force immediately before it is amended by the amendment Act). 21 Restricted use of certain confidential information in deciding section 35AA application 1 This clause applies to any information received by the Director-General that is— a provided in support of— i an innovative TNP application or a non-innovative TNP application made under old section 26; or ii a deemed application to which clause 12 applies; and b is confidential information (within the meaning of section 73(2)) about the trade name product that is the subject of that application or deemed application. 2 During the protected period that applies to the information, the Director-General must not use that information in determining whether to grant an innovative application, or a non-innovative application, that is a section 35AA application. 3 Subclause (2) — a does not limit section 74A (as in force before its amendment by the amendment Act), as applied by clause 12(2) or 20(2) ; and b is subject to section 74H (as amended by the amendment Act). 4 In this clause,— innovative application and non-innovative application have the same meanings as in section 72(1) (as amended by the amendment Act) innovative TNP application and non-innovative TNP application have the same meanings as in section 72(1) (as in force immediately before it is amended by the amendment Act) protected period has the same meaning as in section 74 (as in force immediately before it is amended by the amendment Act) section 35AA application has the same meaning as in section 72(1) (as amended by the amendment Act). 2 Consequential amendments related to Part 1 After section 181(a), insert: aa any agricultural compound that is the subject of a consent for that use under section 35AAD of the Agricultural Compounds and Veterinary Medicines Act 1997 and is used— i in accordance with the conditions imposed on the consent; and ii by the holder of the consent or, if the consent allows the sale to and use by a person or a class of persons, the person or a person belonging to that class (as the case may be); or In section 2(1), repeal the definitions of innovative medicine application and innovative TNP application . Replace section 25(6) with: 6 A person may do a thing specified in subsection (1)(a) or (b) in relation to any hazardous substance or new organism that is or has been the subject of any of the following kinds of application only if the person has applied for and been granted an approval under this Act to do the thing: a an innovative medicine application (as defined in section 23A of the Medicines Act 1981): b an innovative application (as defined in section 72(1) of the Agricultural Compounds and Veterinary Medicines Act 1997): c an innovative TNP application (as defined in section 72(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 as in force immediately before the repeal of that definition by the Agricultural Compounds and Veterinary Medicines Amendment Act 2026 ): d an innovative agricultural compound application (as defined in section 72 of the Agricultural Compounds and Veterinary Medicines Act 1997 as in force immediately before 7 November 2016). In section 55(3)(a), after innovative medicine application , insert as defined in section 23A of the Medicines Act 1981 . Replace section 55(4)(a) with: a 1 or more of the following apply: i the hazardous substance or new organism to which the application under this Act (the HSNO application ) relates is or has been the subject of an innovative application (as defined in section 72(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act )); or ii the hazardous substance or new organism to which the HSNO application relates has been the subject of an innovative TNP application (as defined in section 72(1) of the ACVM Act as in force immediately before the repeal of that definition by the Agricultural Compounds and Veterinary Medicines Amendment Act 2026 ); or iii the hazardous substance or new organism to which the HSNO application relates has been the subject of an innovative agricultural compound application (as defined in section 72 of the ACVM Act as in force immediately before 7 November 2016); and