Application for a Licence to Manufacture
Veterinary Chemical Products
Australian manufacturers that carry out any step(s) of manufacture of veterinary chemical products are
required by the Agricultural and Veterinary Chemicals Code to hold a current valid licence and comply
with any conditions applied to that licence except where exempted by the Regulations (Agricultural and
Veterinary Chemicals Code Regulations 1995 Regulations 59, 59A, 59B, 59C and 59D), The
manufacturer is also required to notify the APVMA of changes to the manufacturing activities that are
covered by the licence. Some of these changes may require the issue of a new licence,
This application form should be completed by each manufacturer who carries out any step of
manufacture of veterinary chemical products in Australia in order to obtain a licence.
This form should also be completed by licensed manufacturers seeking a new licence for changes to
manufacture, including changes to premises, legal entity and / or significant changes to the scope of
their licence.
IMPORTANT
It should be noted that facilities may need to be audited and non-conformances addressed
before a licence is issued by the APVMA to allow manufacture to commence. Therefore
applications should be submitted to the APVMA at least 4 months before a licence is
required.
An application MUST be submitted before an audit takes place.
Manufacture must not commence until a licence is issued to the applicant by the APVMA.
Send the completed and signed form (and any attachments):
BY POST TO:
Manager, Manufacturing Quality and Licensing Section
Australian Pesticides and Veterinary Medicines Authority (APVMA)
PO Box 6182
KINGSTON ACT 2604
BY EMAIL TO: MLS@apvma.gov.au
BY FAX TO: (02) 6210 4813
Please note: Pursuant to regulation 72A(2) of the Agricultural and Veterinary Chemicals Code
Regulations 1995 (Agvet Code Regulations) , the fee payable for an application for the issue of a
licence is $900. Payment can be made by cheque or credit card. Please refer to page 3 for payment
details. Please note that the licence application will not be progressed until payment of the fee has
been received.
Page 1 of 19
Do I need to apply for a licence to manufacture a veterinary chemical product?
If you are unsure about how to answer these questions you should contact the Manufacturing
Quality and Licensing Section on 02 6210 4899.
I.
Do you hold a current licence to manufacture veterinary chemical products?
 yes [request existing licence number go to question III]
 no [go to question II]
II.
Is the product you are seeking to perform a step or steps in the manufacture of a product defined as
a veterinary chemical product under section 5 of the Agvet Code?
 yes [go to question IV]
 no [a licence may not be required: proceed to question IV]
III.
Are you
 acquiring an additional manufacturing premises, OR
 relocating your manufacturing premises, or
 changing the ownership of the company or legal entity or premises changing, or
 seeking to change the scope of the manufacture which would result in a change of licence
category?
If you ticked any of the above – a new licence is required
If none of the above applied – proceed to question IV
IV.
Is the product declared to be an exempt product under regulation 59 of the Agvet Code Regulations?
 yes [a licence is not likely to be required]
 no [a new licence is required
V.
Will the substance or mixture of substances either
a) be prepared by a pharmacist in accordance with the instructions of a veterinary surgeon or
b) be prepared by a veterinary surgeon
in the course of the practice, by the person preparing the substance or mixture of substances, of his
or her profession as permitted by or under a law of this jurisdiction
 yes [a licence may not be required]
 no [proceed to question VI]
VI.
Are you performing a single step in the manufacture of a veterinary chemical product where the
person is considered to be an exempt person for the purposes of regulation 59A?
 yes [proceed to question VII]
 no [a licence is required proceed to complete the application form]
VII.
If you only perform storage of product, is the product still under quarantine when you receive it and
are you required to wait for formal approval from the product manufacturer or product registration
holder before this product is released for supply?
 yes [a licence is required proceed to complete the application form]
 no a licence may not be required]
.
Page 2 of 19
Australian Pesticides and Veterinary Medicines Authority
ABN 19 495 043 447
______________________________________________________________
INVOICE
LICENCE APPLICATION FEE PAYMENT
______________________________________________________________
For:
Please
enter
company
name
and site
address
details
Amount Due:
$900.00
GST: Please note that licence application fees are not subject to GST.
Methods of Payment:
By Cheque:
Please make your cheque payable to the “APVMA” and send (with a copy of this invoice and application form)
to:
Manager, Manufacturing Quality & Licensing Section
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Using Credit Card:
Enter your credit card details and sign below then fax to 02 6210 4813
Amount Paid: _____________________________
. Visa
Credit Card Number:
. Mastercard
.
.
.
. Diners Club
.
.
.
.
.
.
. American Express
.
.
.
.
.
.
.
Name on Credit Card: _____________________________________________
Expiry: ____ / _____ Signature: ____________________________________
For enquiries please contact Manufacturing Quality and Licensing Section on 02 6210 4899
Page 3 of 19
Section A. Licence Application
Reason for
Application
 New Manufacturer (not currently licensed)
(please tick)
 Change of Ownership of Company/Premises or change of legal entity
 Relocation of Manufacturing Premises
 Change of Scope of Licence (requiring a new licence)
 Other: …………………………………………………………………………………..
APVMA
Licence
Does the applicant hold an existing APVMA licence?
No 
Yes  APVMA Lic. No: …………
Explanatory
Comments
APVMA USE ONLY
Progress Application


YES
Reviewed by:
NO
File No. Allocated: M-
Date:
Comments:
Application Fee Payment received:  YES

NO
Page 4 of 19
Receipt Number:
Section B. Applicant Details (Licence Holder)
1. Registered company name (as listed by the Australian Securities and Investments Commission).
If not a registered company, please list full name/s of business owners/partners, or details of other
legal entity, such as trust, government department etc. The nominated licence holder must be a
legal entity.
2. ACN Details:
ACN:
If no ACN is held, please provide an ABN: …………………………………………..
3. Trading Name or other business name (if used)
4. Street address of the main premises at which the manufacture of veterinary chemical products
in Section B will be carried out. (This will be referred to as the main premises).
5. Postal address (if different to above)
6. Premises contact details
Telephone No.
Facsimile No.
General email contact
Website (if any)
Page 5 of 19
7. Name of primary contact responsible for receiving notices from the APVMA.
Please note: This person will also be considered the primary contact for all licensing/GMP
matters unless the APVMA is otherwise advised.
Title (Mr, Ms, Dr etc)
Full name
Position
Phone number
Mobile number
Fax Number
Email address
Postal address (if
different to site
postal address in
Q5)
8(a).
Does this application include manufacturing premises owned or leased by the applicant other
than those listed as the main premises in Question 4, where the same kind(s) of products are
manufactured using the same procedures, the same steps of manufacture and under the
same direct production and quality control management as those already listed under Question
4. (This will be referred to as secondary premises).
Yes* 
No 
* If yes, please attach or list below the addresses of the premises
8(b). Does this application include manufacturing premises owned or leased by the applicant other
than those listed in Question 4 and Question 8(a) where starting materials, work in progress or finished
products are stored? (This will be referred to as tertiary premises).
Yes* 
*
No 
If yes, please attach or list below the addresses of the premises
Page 6 of 19
Section C. Details of Manufacture Performed
9.
Do you perform only analysis and testing of veterinary products? (single-step manufacture is
considered to be Category 6 for APVMA licensing purposes)
Yes   go to Question 12
10.
No   go to Question 10
Do you perform only a single step in the manufacture of veterinary products (other than
testing), for example, packing and/or labelling, or sterilisation? (single-step manufacture is
considered to be Category 6 for APVMA licensing purposes as defined by regulation 3 of the
Agvet Code Regulations)
Yes   then go to Question 12
11(a)
No   go to Question 11
Please specify what category/ies and types of veterinary chemical product manufacture that
are or will be manufactured at the premises listed in Question 4, and where applicable 8(a) and
8(b) (tick one or more of the boxes).
Category
Category 1
Main
Premises
(Q4)
Secondary
Premises
(Q8a)
Tertiary
Premises
(Q8b)















Tablets



Capsules – hard shell



Capsules – soft gel



Pellets



Bolus



Creams/Lotions



Ointment



Gels



Pastes



Powders



Granules



Sprays



Aerosols



Liquids – oral



Liquids - topical



Suspensions



Other (specify in 11b)



Type of
Manufacture
Dosage Form (example - not
Sterile and/or
immunobiological
products
Immunobiologicals
necessarily complete list)
Please tick box
Sterile products for injection
Sterile products for topical
use
Subcutaneous implants
Other (specify in 11b)
Category 2
Non sterile
veterinary
preparations
except
Categories 3 and
4
Page 7 of 19
Category
Category 3
Category 4
Main
Premises
(Q4)
Secondary
Premises
(Q8a)
Tertiary
Premises
(Q8b)
Liquids



Pastes



Sprays



Aerosols



Powders



Collars



Ear tags



Other (specify in 11b below)



Premix – liquid



Premix - powder



Supplements – liquid



Supplements - powder



Therapeutic Pet Foods



Probiotics



Other (specify in 11b)



Type of
Manufacture
Dosage Form (example - not
Ectoparasiticides
(for external
application)
Premixes /
Supplements
necessarily complete list)
Please tick box
11(b) . Complete this section if you ticked “other” in any of the categories in Question 11(a).
12(a).
State the step(s) of veterinary manufacturing carried out, or planned to be carried out, on the
premises listed in Question 4 (the main manufacturing premises) and, where applicable,
secondary and tertiary manufacturing premises.
Tick for Appropriate
Category
Main
Premises
(Q4)
Step of Manufacture
Quality assurance (QA) of raw materials
Serum collection
Blood collection
Plasma collection
Colostrum collection
Management and immunisation of donor animals
Bacterial fermentation
Fungal fermentation
Virus cultivation
Chemical synthesis
Formulation including blending
Dry milling
Wet milling
Granulation
Filling
Aseptic filling
Packaging (primary or primary and secondary)
Page 8 of 19
Secondary Tertiary
Premises
Premises
(Q8a)
Q8b)
Tick for Appropriate
Category
Main
Premises
(Q4)
Step of Manufacture
Labelling (primary or primary and secondary)
OR:
Secondary packaging only (no primary)
Secondary labelling only (no primary)
Repackaging (primary)
Relabelling (primary)
Strip packaging (primary)
Blister packaging (primary)
Sachet packaging (primary)
Tableting
Tablet coating
Pellet extrusion
Capsule filling from bulk
Aerosol filling from bulk
Freeze-drying
Metal oxidisation
Spray-drying
Sterilisation:
a) Heat
b) Radiation
c) Gas
d) Filtration
e) Chemical
Microbiological reduction treatment:
a) Heat
b) Radiation
c) Gas
d) Filtration
e) Chemical
Analysis and testing:
Physical
Chemical
Endotoxin testing
Antibiotic assay
Microbiological
Sterility test
Serological
Immunological
Other (please specify)
Storage (in process)
Release for supply (final quality release of finished product)
Other type of manufacturing [please specify in 12(b)]
Page 9 of 19
Secondary Tertiary
Premises
Premises
(Q8a)
Q8b)
12(b). Complete this section if you ticked ‘other’ type of manufacturing in 12(a) above.
13. Do you or do you plan to manufacture immunobiological and/or biological veterinary products?
Yes * 
No   go to Question 14
For biological products, enter below a list of all organisms used in the production areas or for
production purposes:
Product
Organism/s
14. List all veterinary chemical products manufactured, part-manufactured or planned to be
manufactured and/or packed on site*.
This includes all products which are registered (or awaiting registration), subject to permit
and/or export only see Section I, 32(a) of this form for information on accessing APVMA’s
legislation) This information may be provided as an attachment if preferred.
Product Name /
Description
APVMA
Product Holder / Client
Registration
or Permit
No.
Page 10 of 19
Step/s of Manufacture
Performed by Licence
Holder
(ie. “all”, “packaging
only” etc)
Status (ie
registered,
permit,
export
only etc)
15. Do you intend to export any of the above listed products to the European Community (EC)?
Yes * 
No 
* If “YES”, you should be aware that you may need to obtain a Certificate of GMP Compliance of a
Manufacturer issued under the Mutual Recognition Agreement (MRA) between Australia and the EC
(refer to the APVMA’s website for further information, www.apvma.gov.au)
16. Please indicate whether any veterinary chemical products manufactured at any premises listed
above contain any of the following materials:
penicillins
cephalosporins
other antibiotics
cytotoxic medicines
hormones
steroids
chemicals to which any schedule of the SUSMP (Poisons
Standards) applies
Genetically modified organisms
Radioactive
Actives/ingredients containing nano material (less than
100 nanometres)










If you ticked any of the above, please provide details below:
17(a). Are there any non-veterinary chemical products manufactured at any of the premises listed
above? Are these products manufactured using the same equipment as used for manufacturing
veterinary chemical products? (group as appropriate).
Non-veterinary chemical
products manufactured at
same premises (group as
appropriate)
Is the same equipment used?
Yes
No
Yes
No
Yes
No
Yes
No
Page 11 of 19
Comments
Section D. Contract/Subcontract Manufacturing
18. Are there any external laboratories/manufacturers involved in analysis and testing of any of the
veterinary chemical products (or intermediates) produced?
List all manufacturers and laboratories involved in analysis/testing
Name of
Manufacturer
Address
APVMA
Lic. No.
Product
Test/s
performed
19. Are any other steps of your manufacture (such as packaging, sterilising etc, but excluding
provision of raw materials) contracted out to other manufacturers?
Yes  complete details below
No   go to Question 20
List all steps contracted out to other manufacturers
Name of
Manufacturer
Address
APVMA
Lic. No.
Product
Step(s) of
Manufacture
20. If you do not perform release for supply of the products manufactured, who does perform this step?
Name of
Manufacturer
Address
APVMA Lic.
No.
Page 12 of 19
Product
Section E. GMP Licensing by Other Authorities
21. Are the premises to which this application relates currently licensed, certified or accredited for
GMP compliance (or its equivalent) by either of the following authorities/agencies? You will be
required to attach evidence of current licensing, certification or accreditation
Please tick where applicable:
Yes # 

No   go to Section F
Therapeutic Goods Administration (TGA) of Australia
 National Association of Testing Authorities, Australia (NATA)
# If “YES” please attach the following documents:
(please note that the application will not be progressed without this information)
 full copy of that licence, certification or accreditation, including any attachments,
schedules etc.
 full copy of last inspection report and closure advice from that authority
22. If you answered YES to Q21, is the holder stated on the attached licence/accreditation the same
as the manufacturer stated in Q.1 of this application?
Yes 
No  * please provide comment
23. If you hold a TGA licence or NATA accreditation, are all of the veterinary products manufactured
at the premises consistent with the product types/forms and steps of manufacture authorised
under the scope of that licence/accreditation? Please note the APVMA is only able to recognise
the sites, product types and steps of manufacture listed on the licence/accreditation. If you would
like additional product types or steps included which fall outside of the scope these may require
an audit by an APVMA authorised auditor.
 YES
 NO (please specify below which are not covered)
Page 13 of 19
24. If you answered YES to Q.23, are the following aspects of all of your veterinary manufacturing
performed under the same good manufacturing practices as licensed/accredited and inspected
by that authority (please tick appropriate box)
a)
Premises
Yes 
No* 
b)
Plant and equipment
Yes 
No* 
c)
Processes and procedures
Yes 
No* 
d)
Documentation
Yes 
No* 
e)
Personnel (incl. those responsible for Production and Quality )
Yes 
No* 
* If NO to any of the above, please provide further information below:
25. If you are TGA-licensed and have declared that all your veterinary chemical products are
manufactured within the scope of the TGA licence, inspections and all aspects of the
manufacture of these products are performed under the same good manufacturing practices, do
you give, do you give permission for the TGA to inspect your veterinary chemical product
manufacture during their routine GMP inspections of your facility, and to provide the APVMA with
their information relating to the outcome of those inspections?
Please note: If you indicate “yes”, this also means you are giving the APVMA permission to
provide relevant, possibly confidential information to the TGA relating to your veterinary chemical
manufacture. Similarly, you are also agreeing to the TGA releasing relevant information to the
APVMA. If you elect “no” then it is likely that separate audits by an APVMA-authorised GMP
auditor will be required.
Yes 
No 
Do you have any comments about the TGA and APVMA sharing information in relation to your
application, including information about licensing and premises?
Comments:
Page 14 of 19
Section F : Facility Description
Applicants are strongly encouraged to submit a Plant Master File (PMF or Site Master File),
containing a detailed description of the facility operations, personnel and quality systems. If a PMF is
provided, applicants may reference relevant pages of the PMF when answering the following
questions.
Details of Staff
26. Please indicate the numbers of employees engaged in following work areas and the numbers of
shifts of staff per day:
Work Area
Permanent
No.
Staff
No. Shifts
per day
Casual
No.
Staff
No. Shifts
per day
Production
Quality Control
Storage and Distribution
Technical and engineering support services
TOTAL
27. Key Personnel – please provide information below. Please note that these people will be listed on
your APVMA Licence to Manufacture Veterinary Chemical Products and that there are specific
responsibilities associated with these roles which are described within the Agricultural and Veterinary
Chemicals Code Regulations, the Manufacturing Principles 2007 and the Australian Code of Good
Manufacturing Practice for Veterinary Chemical Products. A person should be nominated for both
roles even if you are seeking a single step licence for either analysis and testing or release for supply.
27(a)
Person responsible for PRODUCTION:
Last Name
Title
(Mr, Ms,
Dr etc)
First Name
Position in Company
Degree/Diploma/Experience *
Field of Study
Years of Experience
* where space insufficient, attach list.
Page 15 of 19
27(b)
Person responsible for QUALITY:
Last Name
Title
(Mr, Ms,
Dr etc)
First Name
Position in Company
Degree/Diploma/Experience *
Field of Study
Years of Experience
* where space insufficient, attach list.
Organisational Structure:
28. Attach a diagram of the staff reporting structure for manufacturing and quality control.
(This requirement is for evaluation of the organisational structure of the operation, particularly the
separation of responsibility for quality control from manufacturing or marketing functions).
Or Page reference in PMF:_________________________________
Details of Manufacturing Premises
29. Site Plan
Please attach to this application a diagram showing the location of all buildings and their functions and
activities on the property. The diagram should also indicate the activities carried out on adjacent
properties.
This requirement is to determine whether there is potential for contamination or other detrimental
effects either from on site or from adjacent properties which might impair the manufacturing process.
Or Page reference in PMF:_________________________________
30. Building Plans
30(a) Manufacturing Premises
Please attach line diagrams of the layout of all buildings used for manufacture, storage and quality
control, with the major plant items and equipment identified. The use or activities carried out in each
room should be indicated together with all entrances and exits.
The product flow from raw materials to finished product should be evident. Where several products
are involved it may be necessary to use more than one plan. A brief narrative should be provided to
describe production stages as appropriate.
Or Page reference in PMF:_________________________________
Page 16 of 19
30(b) Premises used ONLY for storage and release from manufacture.
For premises utilised in the storage of finished products for release from manufacture only, please
attach line diagrams of the layout of all buildings used for storage and or distribution. Indicate
quarantine, released, rejected, returned, and recall areas.
Or Page reference in PMF:_________________________________
31. Air Filtration and its Specifications (where applicable)
Where controlled air systems are installed the applicant should provide a description of the systems,
and their specifications, and for cleanrooms the grade of cleanrooms and the number of air changes
per hour and pressure gradients.
These requirements are for evaluation of the production process, layout and flow path through the
premises from raw materials stage through to the end of the process, including storage of materials
and final product.
Or Page reference in PMF:_________________________________
Page 17 of 19
Section G: Applicant Declarations
I, ...................................................................................................................................................
Declaration Part 1:

declare that in accordance with paragraph 123(1)(e) of the Agvet Code, neither the:
-
the applicant for the Licence to manufacture veterinary chemical products (the Applicant); or
any person who makes, or participates in making, decisions that affect the whole, or a
substantial part, of the Applicant’s affairs; or
if the Applicant is a body corporate, a person who is a major interest holder of the body
corporate
has, within the 10 years immediately before this application:
-
-
been convicted of an offence against an agvet law; or
been convicted of an offence against a law of this or another jurisdiction relating to chemical
products; or
been convicted of an offence against a law of the Commonwealth or a law of a State or
Territory involving fraud or dishonesty; or
been found to have committed an offence listed above where the court has not recorded a
conviction; or
been ordered to pay a pecuniary penalty for the contravention of an agvet penalty provision; or
been ordered to pay a pecuniary penalty for the contravention of another law of this or another
jurisdiction relating to chemical products; or
been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a
law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
contravened a condition of a manufacturing licence issued under an agvet law; or
held a manufacturing licence or permit that was cancelled under an agvet law, other than
paragraph 127(1)(d) or (e) of this Code or a corresponding provision of the Agvet Code of
another jurisdiction; or
been a manager, or major interest holder, of a body corporate in respect of which any of the
matters, noted above, applied in that 10 year period, if the conduct resulting in that matter
occurred when the person was a manager or major interest holder of the body corporate.
Declaration Part 2:

declare that in accordance with paragraph 123(1)(f) of the Agvet Code, neither the:
-
the applicant for the Licence to manufacture veterinary chemical products (the Applicant); or
any person who makes, or participates in making, decisions that affect the whole, or a
substantial part, of the Applicant’s affairs; or
- if the Applicant is a body corporate, a person who is a major interest holder of the body
corporate
has, within the 5 years immediately before this application failed to comply with a manufacturing
principle in connection with the manufacture of chemical products.
Declaration Part 3:

declare that I cannot make the declarations set out in Declaration Parts 1 and/or 2 above,
because:
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
Page 18 of 19

request that the APVMA consider the following special circumstances in this case:
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
____________________________________________________________
Please attach further details if required.
Declaration Part 4:
 declare I am aware it is an offence to manufacture chemical products which are prohibited
from manufacture under the Agricultural and Veterinary Chemicals (Administration)
Regulations 1995 unless such manufacture is permitted in accordance with conditions or
restrictions prescribed in the legislation.
 declare that I will not be conducting any step in the manufacture of a chemical product which
are prohibited from manufacture under the Agricultural and Veterinary Chemicals
(Administration) Regulations 1995 unless such manufacture is permitted in accordance with
conditions or restrictions prescribed in the legislation.
 declare that the information provided with this application is complete and correct.
Signature: ________________________________________
Date:
Giving false or misleading information is a serious offence and may lead to prosecution for
an offence against the Agricultural and Veterinary Chemicals Code.
Section H: Privacy Statement
Personal information (within the meaning of the Privacy Act 1988) in this form is collected and used
for the purpose of assessing and granting applications for the manufacture (or particular steps of
manufacture) of chemical products under the Agvet Code. Personal information is also collected and
used for the purpose of varying, renewing and maintaining licences under the Manufacturing
Licencing Scheme.
Personal information will only be disclosed where required by or authorised under law.
Section I: Further Information
(a)
APVMA Legislation
The APVMA’s legislation can be accessed via the APVMA’s website: http://www.apvma.gov.au/
(b)
Manufacturing Principles and Code of GMP
The Agricultural and Veterinary Chemicals Manufacturing Determination 2014 (MPs) and the
Australian Code of Good Manufacturing Practice for Veterinary Chemical Products, 2007 are available
on the APVMA’s website: http://www.apvma.gov.au
A hard copy of the Code of GMP will be provided upon acceptance of your application.
Page 19 of 19