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]
Approval (or Variation of Approval) to Manufacture
Veterinary Medicines and/or Vertebrate Toxic Agents
ACVM 18 (August 2014)

This application from must be completed by each manufacturer in New Zealand who carries out any step of manufacture of a veterinary
medicine or vertebrate toxic agent registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997). (NOTE:
Importers/distributors of HGPs should complete ACVM 17 Approval to Import and/or Distribute Hormonal Growth Promotants
instead of this form.)

This form should also be completed by approved manufacturers seeking approval for changes to their currently approved premises.

Approvals are issued with a scope that defines the approved categories of manufacture. If a manufacturer wishes to manufacture products
in categories other than those for which approval is currently held, an application must be made for the additional categories.

Send this signed, completed application form with all required documentation electronically to the Ministry for Primary Industries at the
above address.

If there are any changes to the details provided in this application after the application has been submitted, you must promptly inform the
Ministry for Primary Industries of the changes in writing.

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 1: Manufacturer Details
1.1 Application is Made for Approval (or Variation of Current Approval) as a Manufacturer of
Veterinary medicines
Vertebrate toxic agents
1.2 Reason for Application
New manufacturer
Change to premises and/or relocating manufacturing facility
Change to scope of approval (product category)
1.3 Registered Company Name
Registered company name or partnership names or individual name.
1.4 Trading Name
If different from the registered company name listed in 1.3.
1.5 Manufacturer Address and Contact Details
Manufacturing Physical Address
Postal Address
Name of Designated Contact Person(s)
This will be MPI’s primary contact, unless otherwise
notified.
Tel
Fax
Mobile
Email
1.6 Secondary Sites of Manufacture
List any secondary sites of manufacture. This could include sites where finished product is stored, sites where
QC tests and analysis are performed, packaging from bulk etc.
Address
AC-APF-105-1.2
Functions (such as storage, QC)
Page 2 of 9
August 2014
Part 2: Details of Manufacturing Performed
2.1 Categories of Manufacture
Select the categories of products you are applying to manufacture. If applicable, select currently approved
categories
Category
Scope
Category 1A
Immunobiologicals
Vaccines
Category 1B
Sterile
Sterile products for injection
Sterile products for topical use
Subcutaneous implants
Category 2
Non sterile veterinary medicines
(except for those in Category 3)
Boluses
Capsules
Creams/ointments
Granules
Liquids (oral)
Liquids (topical)
Pastes
Pellets
Powders
Sprays/aerosols
Suspensions
Tablets
Category 3
Ectoparaciticides for external
application
Aerosols
Collars
Ear tags
Liquids
Pastes
Powders
Sprays
Category 5
Repacking/relabelling
(if VTAs, see 8A below)
Labeling/relabelling only
Repacking and relabelling
Category 6A
Contract QC analysis
Antibiotic assay
Chemical
Endotoxin
Immunological
Microbiological
Physical
Serological
Sterility
Category 6B
Contract sterilisation
Chemical
Filtration
Gas
Heat
Radiation
AC-APF-105-1.2
Applying
for
Page 3 of 9
Currently
approved
August 2014
Category 8
Vertebrate toxic agents
Vertebrate toxic agents
Category 8A
Repacking/relabelling of VTAs
Labeling/relabelling only
Repacking and relabelling
2.2 Manufacturer as the Registrant
Do you manufacture (or are you applying for approval to manufacture) veterinary medicines or
vertebrate toxic agents for which you are the registrant? If YES, complete below.
(delete one)
YES NO
Product Name
Category
Reg Number
2.3 Split Manufacture
Do you engage the services of another entity for the purposes of split manufacture
(including contract testing and analysis, repacking/relabeling, contract sterilisation, release
for supply etc) of veterinary medicines or vertebrate toxic agents? Provide the names of the
other manufacturers involved, the steps each manufacturer performs and provide evidence
of Quality Accreditation. If you are a contract manufacturer performing a step of
manufacturing under contract and do not have details of the other steps of manufacturing
go to step 2.4.
(delete one)
YES NO
Product Name
Steps of
Manufacture
Performed by
Other
Manufacturer
AC-APF-105-1.2
Name and Address of Other
Manufacturer
Page 4 of 9
Steps of
Manufacture
Performed by You
August 2014
2.4 Contract Manufacturer
Do you manufacture (or are you applying for approval to manufacture) any
veterinary medicines or vertebrate toxic agents for which another organisation
is the registrant? If YES, complete below including the steps of manufacturing
conducted e.g. re-packing, QC testing, bulk manufacture, release for supply
etc. If full manufacturing is conducted please enter ‘full manufacturing’
(delete one) YES NO
Product Name
Category
Reg
Number
Registrant Name and Address
Manufacturing
Steps
Conducted
Release for Supply
If you are a contract manufacturer, which entity is responsible for ‘release for supply’ according to the GMP
Contract/Quality agreement?
Company name
and address
2.5 External Services
List or append a list of any service that is provided by an external party that is not GMP approved (eg, water
testing, environmental monitoring, chemical analysis, laundering of clean room garments etc). Include any
relevant Quality accreditation (IANZ, GLP, ISO).
Service Provided
AC-APF-105-1.2
Name of External Service
Provider
Address of External Service
Provider
Page 5 of 9
Quality
Accreditation
August 2014
2.6 Manufacture for Export
List or append a list of any products that are to be manufactured under GMP for export. (Place an * next to any
products also sold in New Zealand.)
Product Name and ACVM Registration Number (if applicable)
Export Destination
2.7 Other Products Manufactured On Site
List or append a list of other products that are manufactured on site. List below or append a list of any
sensitising antibiotics, penicillins, cephalosporins, hormones, steroids, radioactives, cytotoxics, highly toxic
agents.
Are there any non-veterinary products (such as pesticides, agricultural chemicals)
manufactured on the premises? List below.
(delete one) YES NO
If YES, are these manufactured using the same equipment?
(delete one) YES NO
AC-APF-105-1.2
Page 6 of 9
August 2014
2.8 Biological Products
For biological products, list or append a list of all organisms used in manufacturing areas.
Part 3: Approval by Other Authorities
3.1 Is the manufacturing premises licensed, certified or registered by any other
domestic or international regulatory authority?
If YES, attach appropriate current evidence.
(delete one)
YES NO
3.2 Does the manufacturing premises have any other quality accreditation (GLP, ISO,
IANZ)?
If YES, attach appropriate current evidence.
(delete one)
YES NO
Part 4: Details of Manufacturing Premises and Operations
4.1 Site Master File
Append to this application a Site Master File (or equivalent) to illustrate the quality system used in
manufacturing. MPI has adopted the PIC/S explanatory notes for industry on the preparation of a Site Master
File. This can be found at the link: http://www.tga.gov.au/industry/manuf-pics-site-master-file.htm
4.2 Site Plan
Append to this application a diagram showing the location of all buildings and their functions and activity. This
diagram should also indicate the activities carried out on adjacent properties.
4.3 Building plans
Append to this application line diagrams of the layout of all building used for storage, manufacture and quality
control. The major plant items and equipment should be identified. The use and activities carries out in each
room should be indicated with all entrances and exits.
Where controlled air systems are installed provide a plan that indicates the positions of inlet and outlet grills and
ducts, the filters installed and their specifications. In aseptic rooms the number of air changes per hour and the
pressure gradients between controlled rooms should be included.
4.4 Process Flow
Append to this application flow diagrams that show the production process from the raw material stage to the
AC-APF-105-1.2
Page 7 of 9
August 2014
finished product stage. Where several products are manufactured on site it may be necessary to use more than
one diagram. Step-by-step descriptions of the each stage of manufacture should be provided, including steps
where contractors are used.
Part 5: Staff Responsibilities
5.1 Person Responsible for Production
Name
Position in Company
Relevant
Qualifications and
Experience
5.2 Person Responsible for Quality
For companies responsible for ‘release for supply’, this includes the person with the responsibility of formally
releasing the product to market.
Name
Position in Company
Relevant
Qualifications and
Experience
5.3 Organisational Chart
Append a staff organisational chart to this application.
Part 6: Applicant Statement
Applicant Statement
This section should be completed by a senior member of staff (such as CEO, Director, person responsible for
Quality System)
I confirm that:

I am authorised to make this application as the applicant OR a person with legal authority to act on behalf
of the applicant noted in section 1.3; and

the information supplied in and with this application is truthful and accurate to the best of my knowledge.
Name
Tel
Email
Signature
Date
AC-APF-105-1.2
Page 8 of 9
August 2014
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 approving a manufacturer of veterinary medicines or vertebrate toxic agents
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; 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 may ultimately
result in a refusal to approve the manufacturer; 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 application, 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.
AC-APF-105-1.2
Page 9 of 9
August 2014