Approvals Operations Group Regulation and Assurance Ministry for Primary Industries Pastoral House, 25 The Terrace PO Box 2526, Wellington, New Zealand 6140 Tel: 04 894 2550, fax: 04 894 2566 Email: [email protected] Agricultural Chemical Product Data Sheet ACVM 1-3 (August 2014) This form is to be completed by the Registrant or their nominated New Zealand Agent/Consultant. Registration (section 21) of a non-exempt ACVM trade name product is required to avoid committing an offence (section 8) under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997. Under section 10 of the ACVM Act, you must fill out this form as part of your application to register a trade name product. Use the Agricultural Chemical Product Data Sheet Guide (on the website) to help you. For new registrations: Send this completed form, all required supporting documentation, and the separate completed application form (ACVM 1-1) electronically to [email protected]. For variations and updates to this document: You must inform the Ministry for Primary Industries of any changes to the contents of this document. Complete the variation section on ACVM 1-1, make changes to the relevant page(s) of this PDS, and send electronically to [email protected]. Refer to the Privacy Act 1993 and Official Information Act 1982 notices at the end of this form regarding collection of information by the Ministry for Primary Industries. Part A: General Information A1 Trade Name of the Agricultural Chemical See guideline for wording of trade name and list of prohibited substances. Trade Name Reg Number (if assigned) A2 Registrant Information See guideline. Registrant’s Full Legal Name Overseas applicants, provide Companies Act reference number Street/Physical Address (for service) Postal Address (for communication) Contact Name Tel Mobile Email Read “Identification Table” on page 1 of guideline before completing this footer. (Ignore ACVM Use table.) Reg No Trade Name P ACVM Use 1 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date A3 New Zealand Agent Complete only if you have appointed an agent in New Zealand (This is compulsory for overseas companies.) See guideline. Name of Organisation/Company Street/Physical Address (for service) Postal Address (for communication) Contact Name Tel Mobile Email A4 New Zealand Consultant Complete only if a New Zealand consultant is managing the registration process for you. Note that a Letter of Authorisation is required. See guideline. Name of Organisation/Company Street/Physical Address (for service) Postal Address (for communication) Contact Name Tel Mobile Email Reg No Trade Name P ACVM Use 2 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date A5 Product Type See guideline. A6 Formulation Type See guideline. A7 Overseas Regulatory Status See guideline. General Information that is Part of the Product and Manufacturing Specifications A8 Label Information Provide an electronic copy of the label. See guideline. A9 Shelf Life of the Formulated Product List the shelf life in months. A10 Pack Sizes and Ranges See guideline. Reg No Trade Name P ACVM Use 3 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date Part B. Product and Manufacturing Specifications-Commercially Sensitive Information B1 Active Ingredient Manufacturer/Formulator See guideline. Active Ingredient Manufacturer’s/ Formulator’s Name Site Address Postal Address (if different) B2 Active Ingredient Minimum Purity and Impurities See guideline. Active Ingredient Reg No Manufacturer/Formulator Trade Name P ACVM Use 4 of 12 AC-AFT-1-3.2 Aug 2014 % Minimum Purity Impurity and % Registrant or Authorised Person’s Signature Date B3 Formulation Details See guideline. Ingredient Name (Common or Chemical) CAS Number Quantity (g/kg or g/L) Function Specific gravity Other information about formulation (for example, overage, isomers) Reg No Trade Name P ACVM Use 5 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date B4 Manufacturer(s)/Formulator(s) of the Formulated Product See guideline. Company name Street address of manufacturing site Manufacturing step/ Function Provide details of the main company responsible for ‘release for supply’ of this product Company Name Site Address Postal Address (if different) Reg No Trade Name P ACVM Use 6 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date B5 Manufacturing Process State typical batch size or range Provide a flowchart (either within this box or as an electronic attachment to this document) representative of the manufacturing process from beginning of the process until release. Reg No Trade Name P ACVM Use 7 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date B6 Specifications of the Formulated Product Release Specifications See guideline. Parameter Range (include units if applicable) Method Range (include units if applicable) Method Expiry Specifications See guideline. Parameter Reg No Trade Name P ACVM Use 8 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date B7 Packaging Details See guideline. Reg No Trade Name P ACVM Use 9 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date B8 Distribution Process (if applicable) Complete only if storage and/or transport require special conditions, such as refrigeration, or if there are restrictions on who may purchase the product. See guideline. Reg No Trade Name P ACVM Use 10 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date B9 Biosecurity Authorisation Complete if the product contains an ingredient(s) originating from an organism. See guideline. Has biosecurity authorisation been granted? (put an X next to correct answer) NA Yes If Yes, provide details or name of Import Health Standard in space below Does the product contain a viable new organism, including genetically modified organisms (GMOs)? If Yes, then complete box below. No Yes Provide the following additional details if the product contains viable new organisms. systematic name and strain of the bacteria, protozoa, fungi, Rickettsia, nematode or virus and the taxonomic description of the agent, serotype, strain or mutant common name or alternative and superseded names composition of the unformulated material, microbiological purity, nature and identity of any culture media, impurities and content of extraneous organisms viability of an organism (that is, live, attenuated, killed or inactivated). B10 HSNO Approval HSNO status must be obtained before registration will be issued. See guideline. Status of a Substance to the EPA under the Hazardous Substances and New Organisms Act 1996 SOS # EPA Approval Code: HSR Self-determination that the trade name product is nonhazardous Reg No Trade Name P ACVM Use 11 of 12 AC-AFT-1-3.2 Aug 2014 Registrant or Authorised Person’s Signature Date Part C: Statement and Notices Applicant Statement I confirm that: I am authorised to make this application as the registrant OR a person with legal authority to act on behalf of the registrant noted in section A2; and the information supplied in and with this application is truthful and accurate to the best of my knowledge; and I understand that, if this product is registered, any change to the information provided in this application must go through the ACVM Group’s ‘variation to registration’ process or I will be in breach of the product’s registration conditions. Name Tel Signature Email Date Collection of Information Collection of Personal Information Pursuant to Principle 3 of the Privacy Act 1993, we advise that: This information is being collected for the purpose of registering an agricultural chemical as a trade name product under the ACVM Act; and The recipient of this information, which is the agency that will collect and hold the information, is the Ministry for Primary Industries, PO Box 2526, Wellington 6140; and Some of the information being collected will be displayed on a public register; and The collection of information is authorised under section 10 of the ACVM Act; and The provision of this information is necessary in order to process this application for registration; and The supply of this information is voluntary; and Failure to provide the requested information is likely to result in a return of the application form to the applicant, and in accordance with the ACVM Act, may ultimately result in a refusal to register the product; and Under Principles 6 and 7 of the Privacy Act 1993, you have the right of access to, and correction of, any personal information which you have provided. Collection of Official Information All information provided to the Ministry for Primary Industries is official information and may be subject to a request made under the Official Information Act 1982. If a request is made under that Act for information you have provided in this declaration, the Ministry for Primary Industries will consider any such request, taking into account its obligations under the Official Information Act 1982 and any other applicable legislation. ACVM Use 12 of 12 AC-AFT-1-3.2 Aug 2014
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