Veterinary Medicine Product Data SheetACVM 1-2 (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 Veterinary Medicine 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 .

§  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 .

§  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 Veterinary Medicine
See guideline for wording of trade name and list of prohibited substances.
Reg Number (if assigned)
A2 Registrant Information
See guideline.
Full Legal Name
Overseas applicants, provide Companies Act reference number
Street/Physical Address (for service) / Postal Address (for communication)
Contact Name / Tel
Mobile
Email
Reg No / Trade Name / Authorised Person’s Signature / Date
A
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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)
Nominated Contact’s Name
Is the person named below the primary contact for this product? (delete one) YES NO / 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 / Registrant or Authorised Person’s Signature / Date
A
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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.
Unbroached Shelf Life
In-Use Shelf Life (if applicable)
A10 Pack Sizes and Ranges
See guideline.
Reg No / Trade Name / Registrant or Authorised Person’s Signature / Date
A
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Part B. Product and Manufacturing Specifications--Commercially Sensitive Information

B1 Active Ingredient Manufacturer
See guideline.
Active Ingredient / Manufacturer’s Name / Site Address / Postal Address (if different)
B2 Active Ingredient Minimum Purity and Impurities
See guideline.
Active Ingredient / Manufacturer / Grade / % Minimum Purity / Impurity and Amount
Reg No / Trade Name / Registrant or Authorised Person’s Signature / Date
A
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B3 Formulation Details
See guideline.
Ingredient Name
(Common or Chemical) / CAS Number / Standard / Quantity
(g/kg or g/L) / Function
Specific gravity
Other information about formulation (for example, overage, isomers)
Reg No / Trade Name / Registrant or Authorised Person’s Signature / Date
A
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B4 Manufacturer(s) of the Formulated Product
See guideline.
Company name / Street address of manufacturing site / Manufacturing step/Function / Approval
(A, B or C)
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 / Registrant or Authorised Person’s Signature / Date
A
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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 / Registrant or Authorised Person’s Signature / Date
A
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B6 Specifications of the Formulated Product
Release Specifications
See guideline.
Parameter / Range (include units if appropriate) / Method
Expiry Specifications
See guideline.
Parameter / Range (include units if appropriate) / Method
Reg No / Trade Name / Registrant or Authorised Person’s Signature / Date
A
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B7 Packaging Details
See guideline.
Reg No / Trade Name / Registrant or Authorised Person’s Signature / Date
A
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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 / Registrant or Authorised Person’s Signature / Date
A
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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, what is the Biosecurity Approval Number?
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
OR Self-determination that the product fits a group standard approval / EPA Group Standard Number:
OR Self-determination that the trade name product is non-hazardous
Reg No / Trade Name / Registrant or Authorised Person’s Signature / Date
A
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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
Email
Signature / 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 a veterinary medicine 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 in Part A 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.
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