Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015

Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 (LI 2015/93) Jerry Mateparae, Governor-General Order in Council At Wellington this 11th day of May 2015 Present: The Right Hon John Key presiding in Council Pursuant to sections 75, 81D, 81E, and 81H of the Agricultural Compounds and Vet erinary Medicines Act 1997, His Excellency the Governor-General makes the follow ing regulations, acting— (a) on the advice and with the consent of the Executive Council; and (b) on the recommendation of the Minister for Food Safety after— (i) being satisfied that the requirements of sections 81 and 81B of that Act have been met; and (ii) taking into account the results of consultation in accordance with section 78 of that Act. Note Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint. Note 4 at the end of this reprint provides a list of the amendments incorporated. These regulations are administered by the Ministry for Primary Industries. Reprint as at 11 December 2015 1 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415171 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1102999 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1103801 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1103807 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415179 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1102995 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415174 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415174 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM2998524 Contents Page 1 Title 2 2 Commencement 2 3 Interpretation 2 4 Fees, charges, and levies 2 5 When fees, charges, and levies payable 2 6 Director-General may grant exemption, waiver, or refund 3 7 Revocation 3 Schedule 1 Fees and charges 4 Schedule 2 Levies 7 Regulations 1 Title These regulations are the Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015. 2 Commencement These regulations come into force on 1 July 2015. Regulations: confirmed, on 11 December 2015, by section 7 of the Subordinate Legislation (Confirm ation and Validation) Act 2015 (2015 No 119). 3 Interpretation In these regulations, unless the context otherwise requires, Act means the Agri cultural Compounds and Veterinary Medicines Act 1997. 4 Fees, charges, and levies (1) The fees and charges set out in Schedule 1 and the levies set out in Schedule 2 are payable in respect of the matters to which they relate. (2) The fees, charges, and levies are exclusive of goods and services tax. 5 When fees, charges, and levies payable The fees and charges set out in Schedule 1 and the levies set out in Schedule 2 are payable— (a) on the making of the relevant application or on the performance of the relevant service, as the case may require; or (b) in the case of fees payable annually and levies, by 1 October every year. Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Reprinted as at 11 December 2015 2 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM6488929 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM414576 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM414576 6 Director-General may grant exemption, waiver, or refund (1) The Director-General may grant an exemption from, or may waive or refund, any fee or charge set out in Schedule 1 or levy set out in Schedule 2, in whole or in part, in any particular case or class of case. (2) The power conferred by subclause (1) includes power to grant an exemption, waiver, or refund in any of the circumstances described in section 44ZO(1)(a) to (c) of the Act. 7 Revocation The Agricultural Compounds and Veterinary Medicines (Fees and Charges) Regulations 2002 (SR 2002/135) are revoked. Reprinted as at 11 December 2015 Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 r 7 3 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724703 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724703 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM126793 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM126793 Schedule 1 Fees and charges rr 4–6 Part 1 Fees and charges Matter for which fee or charge payable Fee or charge* Fee or charge payable by 1 Consideration by an ACVM officer whether to give authority or clearance under section 5 or 6 of the Act, including determining which of the categories in section 6(1) of the Act goods fall under $102.27 per authority or clearance Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The importer 2 Application under section 8C of the Act for approval of the importation, manufacture, sale, or use of an agricultural compound without registration $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 3 Application under section 9 of the Act to register a trade name product or to vary 1 or more conditions on a registered trade name product $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 4 Responding to inquiries about form and content of applications under section 10 of the Act $155 per inquiry Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The inquirer 5 Assessing whether an application to register a trade name product complies with section 10 of the Act $540 per application The applicant 6 Considering waiver of notice under section 15 of the Act $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 7 Registering in the register of trade name products, in accordance with section 21(1)(d) of the Act, a trade name product or a variation of 1 or more conditions on a registered trade name product $540 per registration or variation The applicant 8 Inspecting the register of registered trade names in accordance with section 24(5) of the Act $155 per inspection Plus inspection charge on hourly basis after the first hour, as specified in Part 2 The person inspecting the register 9 Application to provisionally register a trade name product of an agricultural compound under section 26 of the Act $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant Schedule 1 Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Reprinted as at 11 December 2015 4 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415063 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415064 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1100249 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415071 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415072 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415072 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415079 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415087 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415087 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415090 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415093 Matter for which fee or charge payable Fee or charge* Fee or charge payable by 10 Application for approval of an operating plan under section 28 of the Act, or Director-General giving notice of an amendment to, or revocation of, an approval of an operating plan $155 per application or notice Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant or person to whom notice is given 11 Monitoring compliance with conditions imposed (whether on the registrant, importer, manufacturer, seller, purchaser, or user) under the Act or regulations made under the Act $155 Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The person to whom the conditions apply 12 Suspension under section 30A of the Act of the registration of a trade name product registered under section 21 or 27 of the Act $155 per suspension Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The registrant 13 Application under section 35C of the Act for the Director General to issue a certificate of compliance under section 35A of the Act $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 14 Recall of an agricultural compound under section 35G of the Act $155 per recall Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The person to whom the recall notice is directed 15 Application for recognition under section 44C, 44E, or 44G of the Act $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 16 Recognition of a person under section 44F of the Act without an application $155 per recognition Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The person who is recognised 17 Application for renewal of recognition under section 44Q of the Act $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 18 Application under section 44S of the Act for a new notice of recognition in substitution for an existing notice of recognition $155 per application Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The applicant 19 For each year for which an agency or a person is recognised in accordance with section 44T of the Act $155, payable annually Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The recognised agency or recognised person 20 Inspection in accordance with section 64 of the Act for the purpose of enforcing provisions of the Act $155 per inspection Plus assessment charge on hourly basis after the first hour, as specified in Part 2 The person being inspected Reprinted as at 11 December 2015 Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Schedule 1 5 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415097 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1101343 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415087 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415094 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1101358 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1101356 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1101363 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724154 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724156 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724158 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724157 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724170 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724173 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724174 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415144 Matter for which fee or charge payable Fee or charge* Fee or charge payable by 21 Performance or exercise of a function, duty, or power that is— (a) required to be undertaken under the Act, including under any regulations or notices; and (b) not prescribed elsewhere in these regulations $77.50 Plus assessment charge on hourly basis after the first 30 minutes, as specified in Part 2 The person whose actions resulted in the function, duty, or power being required to be performed or exercised *Fee or charge exclusive of any applicable costs payable under Part 3 or 4 Part 2 Assessment and inspection charges on hourly basis Where Part 1 specifies an assessment or inspection charge on an hourly basis, that charge is to be determined as follows for each hour (or final part-hour) beyond the first 30 minutes or the first hour, as the case may be, spent on assessing or inspecting the matter concerned: Category Fee (a) for each hour (excluding final part-hour) spent by a person (whether or not employed by the Ministry) $155.00 (b) for each 15-minute block in final part-hour spent under paragraph (a) $38.75 (c) for each hour (excluding final part-hour) spent by a person (whether or not employed by the Ministry) under item 1 in Part 1 $102.27 (d) for each 15-minute block in final part-hour spent under paragraph (c) $25.57 Part 3 Costs incurred by Ministry 1 Actual and reasonable costs, including actual and reasonable incidental and ad ditional costs incurred by a Ministry employee, or a person engaged by the Ministry who is not an employee, may be recovered by the Ministry where those costs arise from a request by, or an act or omission of, any person under the Act or regulations or notices made under the Act. 2 The costs in clause 1 include, but are not limited to,— (a) the costs of external review, expert review, notification, product testing, travel, and accommodation; and (b) disbursements such as the costs of photocopying, printing and stationery, telephone, fax, video conferencing, postage, and couriers. 3 For technical staff providing support for the delivery of specialist services in relation to functions, duties, or powers under the Act or any regulations or Schedule 1 Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Reprinted as at 11 December 2015 6 notices made under the Act, a fee of $155 per hour is payable, in 15-minute increments, by the person whose actions result in the function, duty, or power being required to be performed or exercised. Part 4 Travel costs Where travel of a Ministry employee, or a person engaged by the Ministry who is not an employee, is required for any of the matters specified in Parts 1, 2, and 3, an addi tional amount of $0.67 per kilometre travelled by the employee or person is payable in addition to the relevant fee or charge. Schedule 2 Levies rr 4–6 Matters for which levy payable Levy Levy payable by For— (a) development and review of the manner in which declarations under section 7 of the Act must be made; and (b) specifying information requirements under section 10(2) of the Act; and (c) development and review of generic conditions for the purposes of section 23(1) and (2) of the Act; and (d) development and review of the manner in which applications under section 35C(1) of the Act must be made, and specifying information requirements under that section; and (e) development and review of specifications for the purposes of section 44ZN of the Act; and (f) development and review of specifications and requirements for the purposes of section 76A of the Act $540 Payable annually by each— (a) registrant: (b) person who holds an exemption under section 8C of the Act: (c) person who has obtained approval of an operating plan: (d) recognised person Michael Webster, Clerk of the Executive Council. Reprinted as at 11 December 2015 Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Schedule 2 7 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415067 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415072 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM415089 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1101358 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724702 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1102969 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1100249 Explanatory note This note is not part of the regulations, but is intended to indicate their general effect. These regulations come into force on 1 July 2015. They replace the Agricultural Compounds and Veterinary Medicines (Fees and Charges) Regulations 2002 (the principal regulations) and prescribe new fees, charges, and levies payable in respect of matters under the Agricultural Compounds and Veterinary Medicines Act 1997 (the Act). Regulation 1 relates to the Title. Regulation 2 provides that the regulations come into force on 1 July 2015. Regulation 3 defines a term used in the regulations. Regulation 4 provides that the fees, charges, and levies set out in Schedules 1 and 2 are payable and are GST exclusive. Regulation 5 sets out when the fees, charges, and levies are payable. Regulation 6 authorises the Director-General to grant an exemption from, or to waive or refund, any fee, charge, or levy. This power includes power to grant an exemption, waiver, or refund in any of the circumstances described in section 44ZO(1)(a) to (c) of the Act (which concern an application made under section 44I of the Act by 1 per son for more than 1 type of recognition, an application made under section 44Q of the Act by 1 person to renew more than 1 type of recognition, and 1 person being liable under section 44T of the Act to pay a prescribed fee, charge, or levy for ongoing rec ognition under more than 1 of sections 44C to 44G of the Act). Regulation 7 revokes the Agricultural Compounds and Veterinary Medicines (Fees and Charges) Regulations 2002. Schedule 1 prescribes the fees and charges payable under these regulations and who is responsible for paying them. The fees and charges include— • a fee for 20 types of matters and processes: • a fee for the performance or exercise of a function, duty, or power required to be undertaken under the Agricultural Compounds and Veterinary Medicines Act 1997 and not prescribed elsewhere in the regulations: • actual and reasonable costs, including actual and reasonable incidental and ad ditional costs incurred by a Ministry employee, or a person engaged by the Ministry who is not an employee, such as the costs of external review, expert review, product testing, travel, and accommodation, and also the costs of dis bursements for the functions referred to in the schedule. Schedule 2 prescribes the levies payable under these regulations and who is respon sible for paying them. These regulations will be treated as having been revoked with the close of 30 June 2016 unless they are confirmed by an Act of Parliament passed on or before that day (see section 81L of the Act). Explanatory note Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Reprinted as at 11 December 2015 8 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM126793 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM126793 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM414576 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724703 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724161 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724170 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724174 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM4724154 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM126793 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM126793 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM414576 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM414576 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM1103815 Regulatory impact statement The Ministry for Primary Industries produced a regulatory impact statement on 18 March 2015 to help inform the decisions taken by the Government relating to the contents of this instrument. A copy of this regulatory impact statement can be found at— • http://mpi.govt.nz/law-and-policy/legal-overviews/regulatory-impact-state ments/ • http://www.treasury.govt.nz/publications/informationreleases/ris Issued under the authority of the Legislation Act 2012. Date of notification in Gazette: 14 May 2015. Reprinted as at 11 December 2015 Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Explanatory note 9 http://mpi.govt.nz/law-and-policy/legal-overviews/regulatory-impact-statements/ http://mpi.govt.nz/law-and-policy/legal-overviews/regulatory-impact-statements/ http://www.treasury.govt.nz/publications/informationreleases/ris http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM2997643 Reprints notes 1 General This is a reprint of the Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 that incorporates all the amend ments to those regulations as at the date of the last amendment to them. 2 Legal status Reprints are presumed to correctly state, as at the date of the reprint, the law enacted by the principal enactment and by any amendments to that enactment. Section 18 of the Legislation Act 2012 provides that this reprint, published in electronic form, has the status of an official version under section 17 of that Act. A printed version of the reprint produced directly from this official elec tronic version also has official status. 3 Editorial and format changes Editorial and format changes to reprints are made using the powers under sec tions 24 to 26 of the Legislation Act 2012. See also http://www.pco.parlia ment.govt.nz/editorial-conventions/. 4 Amendments incorporated in this reprint Subordinate Legislation (Confirmation and Validation) Act 2015 (2015 No 119): section 7 Wellington, New Zealand: Published under the authority of the New Zealand Government—2015 Notes Agricultural Compounds and Veterinary Medicines (Fees, Charges, and Levies) Regulations 2015 Reprinted as at 11 December 2015 10 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM2998516 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM2998515 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM2998532 http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM2998532 http://www.pco.parliament.govt.nz/editorial-conventions/ http://www.pco.parliament.govt.nz/editorial-conventions/ http://prd-lgnz-nlb.prd.pco.net.nz/pdflink.aspx?id=DLM6488929