A registered chemical product can be varied via several different pathways. To vary the details for the sites of product manufacture a variation can be made by:
- notifiable variation (agricultural products only) – NV
- prescribed variation (veterinary chemical products only) – Item 13A
- non-technical fixed fee application – Item 12
- technical modular application – Item 14.
This information applies to both agricultural and veterinary chemical products (agvet) unless otherwise stated. This guidance does not contain information about varying the sites of manufacture for active constituents.
The legislation
The Agvet Code sets out the requirements for varying the relevant particulars and conditions, of a registered chemical product (Agvet Code, s 29). A variation to the site of product manufacture (such as the addition of a site, the change of the name of a site, or removal of a site) constitutes a change to the relevant particulars. Where the change to the site involves an overseas site of manufacture for a veterinary product there may also be a variation to the conditions.
To determine any kind of variation the APVMA must be satisfied that the chemical product would still meet the safety criteria, the trade criteria, and the efficacy criteria, if the relevant particulars were varied. For a variation to the site of manufacture the APVMA must take into account how the product is formulated (see s 5A(3)(a)(iii)), and the conditions to which the registration is subject to (see s 5A(3)(a)(v)) in relation to manufacturing.
The legislation allows some variations to be lodged as either notifiable variations (see s 26AA–AD) or as prescribed variations (see s 26A–D).
The types of changes that are permissible for notifiable variations and prescribed variations are set out in the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2019 and the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019.
Selecting the appropriate pathway
When and how each of these pathways apply is detailed below. Please choose from the following for tailored guidance on the type of variation you wish to make.
Information on each pathway will appear at the bottom of this page once you have made a selection. You can change your selection at any time.
OR
Note:
Some veterinary chemical products, such as antibiotics which are pure active constituent products, have special Good Manufacturing Practice (GMP) requirements and may require a more tailored assessment approach. You should use the decision tree to determine the pathway for these application types. You may also wish to consult the veterinary data guidelines for more specific information, prior to submitting your application.
a) I want to vary the sites of manufacture for my agricultural product
For agricultural products, variations to the sites of manufacture, including addition or removal of a site, are all processed as notifiable variations. Notifiable variations are not an application, but you will be issued with a notification to confirm that the variation to the relevant particulars has been applied.
Timeframe and fees
Notifiable variations can be submitted to include changes to the site of manufacture across a range of products, as long as the proposed variation can be applied to the whole range.
There is a fee of $50 for each notification (per product, NOT per site to be varied).
A notifiable variation is taken to have effect on the day it is lodged as long as it meets the notice requirements. The APVMA has 28 days to advise you of the notification.
What you need to provide
To meet the notice requirements, you will need to provide:
- a completed form for the notification. This should include a list of all the products for which the notification should apply. If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application
- the fee of $50 per product which is listed on the application form should accompany the notification form.
Summary
All variations to sites of product manufacture for agricultural products are processed via notifiable variation.
Example
Objective: application is made to vary a group of agricultural chemical products to include six new sites of product manufacture.
Background: five of the sites are located in Australia and one site is located overseas, in China. The application also contains three sites to be removed from the register.
Application requirements: an application of this nature is considered under a notifiable variation. One application can be submitted for all products and the fee will be applied per product.
What you should do
If you want to change the site of manufacture for an agricultural product [only]:
You will be redirected to the Online Services Portal to log in.
b) I want to vary the site of manufacture for my veterinary product and the variation involves local (Australian) sites of manufacture ONLY
For veterinary chemical products, variations to local (located in Australia) sites of manufacture (such as the addition of a site, a name change or removal of a site) are processed as prescribed variations. A prescribed variation is an application currently submitted under Item 13A.
Timeframe and fees
Prescribed variations can be submitted to include changes to the site of manufacture across a range of products, as long as the proposed variation can be applied to the whole range.
There is a fee of $175 for each variation application (per product, NOT per site to be varied).
A prescribed variation has a timeframe of one month. The variation is taken as having been accepted if that APVMA has not notified you of a refusal within one month.
What you need to provide
Prescribed variations need to meet the application requirements as set out in section 8A ('Definition of meets the application requirements').
To meet the application requirements you will need to provide:
- a completed application form for the variation. This should include a list of all the products for which the variation should apply. The proposed step/s of manufacture should be included on the application form (do not select ‘all steps’) to allow the APVMA to check the proposed steps against the nominated licence for the manufacturer, as specified in the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019. If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application
- the fee of $175 per product application should accompany the application form.
Note:
Manufacturers in Australia must hold a manufacturing licence issued by the APVMA to manufacture veterinary chemical products. The application form should include the correct and current details for all sites of manufacture to which a variation is to be applied; this includes sites to be added and/or deleted from the registered particulars. If you are unsure of which sites are correctly recorded on the register you may wish to include details for all sites involved in any step of manufacture.
A site of manufacture is any location where manufacturing takes place. 'manufacture' is defined in the Agvet Code (see s 3 (definition of 'manufacture') to mean: ‘to produce the chemical product’, or ‘to engage in any part of the process of producing the chemical product, or any component or ingredient of the chemical product as part of that process, or of bringing the chemical product to its final state, including by formulating, processing, assembling, packaging, labelling, storing, sterilising, testing, supplying or releasing for supply.’
Before nominating a new site of manufacture, the holder of the product should confirm with the site that their current licence covers the steps that you are proposing to use them for.
You can also check this information by consulting the list of licensed Australian manufacturers, in conjunction with any new sites that are published in the APVMA Gazette.
Where a site has changed their name, or location, this is considered a ‘new’ site of manufacture when the change has resulted in the issue of a new licence. This site will need to be added to the registered particulars, and the site it has replaced should be removed from the register.
On the application form you should list the steps of manufacture for each site nominated. Please avoid completing this section with words such as ‘all steps’ as this often requires further clarification and may lead to delays in processing your application
Special considerations for immunobiological veterinary products
For immunobiological products, the only sites that can be added to these products, as a prescribed variation, are those sites of manufacture that are involved in secondary steps. These are steps that do not involve direct contact with the veterinary chemical product and would not result in a change to the stability of the product.
Secondary steps of manufacturing are those that only involve:
- labelling or relabelling or secondary/supplementary labelling
- secondary packaging
- storage
- release for supply
- analysis and testing: any form of testing.
Summary
Most variations to local sites of product manufacture for veterinary products can be processed via prescribed variation.
Example
Objective: application is made to vary a veterinary chemical product to include four new sites of manufacture, and to delete two sites that are no longer in use.
Background: all of the sites are located in Australia. All of the sites have appropriate GMP licences.
Application requirements: an application of this nature is considered under a prescribed variation. If any of sites were located overseas then a prescribed variation would not be appropriate.
What you should do
If you want to change the local site/s of manufacture for a veterinary product [only]:
You will be redirected to the Online Services Portal to log in.
c) I want to vary the site of manufacture for my veterinary product and the variation involves a change to the name of an overseas site ONLY
Variation to an overseas site of manufacture for veterinary products, where the change involves a change in the name of the entity only are processed as prescribed variations. This applies only when the physical site of manufacture has NOT changed and that the change of name is purely administrative. Prescribed variation is an application currently submitted under Item 13A. This applies to all veterinary chemical products including Immunobiological products.
Sites of manufacture are considered registered particulars and should be kept up to date to ensure that the sites that are being used, correspond to the sites listed on the APVMA record.
Timeframe and fees
Prescribed Variations can be submitted to include changes to the site of manufacture across a range of products, as long as the proposed variation can be applied to the whole range.
There is a fee of $175 for each variation application (per product, NOT per site to be varied).
A prescribed variation has a timeframe of one month. The variation is taken as having been accepted if that APVMA has not notified you of a refusal within one month.
What you need to provide
Prescribed variations need to meet the application requirements as set out in the Agvet Code s 8A, 'Definition of meets the application requirements'.
To meet the application requirements, you will need to provide:
- a completed application form for the variation. If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application. This should include a list of all the products for which the notification should apply
- the fee of $175 per product application should accompany the application.
Evidence of Good Manufacturing Practice
You will also need to provide evidence of Good Manufacturing Practice (GMP).
Sites of manufacture that are located outside Australia are not licensed by the APVMA, but need to comply with standards that are equivalent to those applied to Australian manufacturers.
When an overseas site of manufacture changes its name, the registered particulars, for each product that it manufactures, will need to be updated to reflect this change.
You should provide acceptable evidence that the physical site of manufacture has NOT changed and that the change of name is purely administrative. You will need to confirm the address of the site of manufacture as part of this evidence. The address should match the address currently recorded with the APVMA for that site, under its previous name.
Summary
Variations to overseas sites of product manufacture for veterinary products, which only involve the change of the name of the site are processed via prescribed variation.
Example
Objective: application is made to vary a veterinary chemical product to vary the name of an existing overseas site of manufacture.
Background: the site of manufacture has recently been purchased by a rival company and this has resulted in a change of the name of the site only. A new GMP certificate has been issued by a recognised overseas authority and can be provided with the application. The physical address of the site has remained the same.
Application requirements: an application of this nature is considered under a prescribed variation.
If there is evidence that the site has actually moved, for example has been combined with another entity at their site, then it is unlikely that an application could be considered as a prescribed variation, and you should discuss the situation with MQL prior to lodging your application.
What you should do
If you want to change the name of an overseas site of manufacture for a veterinary product [only]:
You will be redirected to the Online Services Portal to log in.
d) I want to vary the site of manufacture for my veterinary product and the variation involves the removal of an overseas site ONLY
To ensure continued compliance post-product registration, the APVMA periodically reviews evidence of overseas GMP compliance. There is an annual overseas GMP compliance assessment fee for each overseas site listed on the APVMA’s Register and is applied under regulation 71A of the Agvet Code. To avoid paying this fee for sites that are no longer needed, holders should apply to have them removed from the APVMA Register.
If a site of manufacture is removed from a product registration, the APVMA must still be satisfied that the remaining manufacturers for that product can perform all required steps of manufacture to a satisfactory standard and in accordance with the Australian GMP code.
Variation to an overseas site of manufacture for veterinary products, where the change involves the removal of an overseas site only, are processed as a prescribed variation or a non-technical assessment depending on whether changes are also needed to the steps of manufacture for overseas sites:
- A prescribed variation (Item 13A) can be used if the proposed variation is to remove an overseas site where all required steps of manufacture for that product are already being conducted by other approved manufacturers for that product. For example, manufacturer X is being removed and manufacturer Y is already approved for all the required steps of manufacture.
- A non-technical assessment (Item 12) is required if the proposed variation to remove an overseas site also involves a change to the steps of manufacture performed at other approved overseas sites for that product. For example, manufacturer X is being removed and manufacturer Y will now need to perform additional steps of manufacture.
Registrants wanting to make the same change across different products can include all products in the one prescribed variation; submit one non-technical assessment for a product followed by a prescribed variation for the other products; or submit individual non-technical assessments for each product.
Applicants applying for a prescribed variation (Item 13A) must specify the steps of manufacture conducted by the manufacturer to be removed, and list which remaining manufacturers will be conducting those steps.
Applicants applying for a non-technical variation (Item 12) must list the manufacturing steps conducted at each site for each manufacturer.
Timeframe and fees
The fee for an Item 12 variation is $2,018. The timeframe is 3 months.
Item 12 applications are subject to an extended assessment period if a section 159 of Agvet Code notice, requiring additional information, is issued and the total extended assessment period would be 5 months.
The fee for an Item 13A variation is $175 per product and the timeframe is one month.
What you need to provide
Item 12 variations will need to meet the application requirements as set out in Part 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
To meet the application requirements, you will need to provide:
- a completed application form for the application. If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application
- the fee of $2,018 should accompany the application. You may choose to pay the initial preliminary assessment fee of $902 on submission with the balance due prior to evaluation.
Applicants can use this form to detail changes to manufacturing steps.
A prescribed variation (Item 13A) will need to meet the application requirements as set out in Part 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
To meet the application requirements, you will need to provide:
- a completed application form for the application. If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application
- the fee of $175 should accompany the application.
Summary
A variation to remove one or more overseas sites of product manufacture for a veterinary product is processed either via non-technical variation (Item 12) or prescribed variation (Item 13a), depending on whether a holder also needs to make changes to the steps of manufacture performed at other approved overseas sites for that product.
What you should do
If you want to remove an overseas site(s) of manufacture for a veterinary product [only] where all required steps of manufacture for that product are already being conducted by other approved manufacturers for that product, go to our Online Services Portal.
If you want to remove an overseas site(s) of manufacture for a veterinary product [only] which involves a change to the steps of manufacture performed at other approved overseas sites for that product, go to our Online Services Portal.
You will be redirected to online services to log in.
e) I want to vary the site of manufacture for my veterinary product and the variation involves the addition of an overseas site of manufacture that performs a secondary step/s of manufacture (a concurrent removal of local or overseas sites of manufacture can be combined with this pathway)
Variation to an overseas site of manufacture for veterinary products, where the change involves the addition of an overseas site that is only involved in a secondary step of product manufacture is processed as a prescribed variation (Item 13A).
A secondary step is limited to those steps that do not result in direct contact with the veterinary chemical product:
- labelling or relabelling or secondary/supplementary labelling
- secondary packaging
- storage
- release for supply
- analysis and testing: any form of physical or chemical testing (excluding biological assays for immunobiological products).
For the addition of an overseas site of manufacture to be processed as a prescribed variation (Item 13A), the site must hold acceptable evidence of Good Manufacturing Practice (GMP). The new site must hold a GMP certificate for the relevant secondary step/s.
- For certification that is product-based, the site must hold appropriate GMP certification for that product.
- For certification that is category-based, the relevant steps must be on the GMP certificate.
It is the product holder’s responsibility to ensure that their product is manufactured (including secondary steps) at a site/s with appropriate GMP accreditation, and that the product meets specifications at the time of release. This may be audited by the APVMA at any time.
Timeframe and fees
Prescribed variations can be submitted to include changes to the site of manufacture across a range of products, as long as the proposed variation can be applied to the whole range.
There is a fee of $175 for each variation application (per product, NOT per site to be varied).
A prescribed variation has a timeframe of one month. The variation is taken as having been accepted if that APVMA has not notified you of a refusal within one month.
What you need to provide
Prescribed variations need to meet the application requirements as set out in section 8A ('Definition of meets the application requirements').
To meet the application requirements, you will need to provide:
- a completed application form for the variation. This should include a list of all the products for which the variation should apply. The proposed step/s of manufacture should be included on the application form (do not select ‘all steps’). If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.
NOTE: the application form is being updated to incorporate this type of prescribed variation. Until the form is updated, applicants should select the ‘Start Application’ button below which will say the purpose of the application is 'to vary the name and/or address of an Australian manufacturer of the chemical product' (even though the variation is for an overseas site of manufacture).
- A declaration that the proposed new site/s has the appropriate GMP certification.
- The fee of $175 per product application should accompany the application form.
Declaration of evidence of Good Manufacturing Practice
You will need to hold GMP evidence for each proposed site. This should not be submitted with your prescribed variation application, however the APVMA may request this evidence at any time. To determine if the site you are proposing to add is recognised by the APVMA you should read the information contained on the following pages:
- Recognition of overseas GMP authorities
- Overseas GMP documentation
- Acceptable evidence of overseas GMP
It is an application requirement that you submit a declaration stating that the proposed new site/s has acceptable evidence of GMP compliance. Please use this declaration and upload it with your application form:
I declare that as the product holder, I have evidence that each secondary step in the manufacture of this chemical product by the manufacturer at the new site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code.
Example 1
Objective
An application is made to vary a veterinary chemical product to include a new overseas site of manufacture that performs the secondary steps of secondary packaging, labelling and storage for release.
Background
The site has not been involved in any steps of manufacture for this product previously. The site has a certificate of GMP from EUDRA for these steps.
Application requirements
A variation of this nature is considered as a prescribed variation. The product registrant would need to hold current and appropriate GMP evidence for the new site of manufacture, but this does not need to be supplied to the APVMA. The holder submits a declaration to the APVMA that the proposed new site of manufacture has appropriate GMP certification.
Example 2
Objective
An application is made to vary a veterinary chemical product to include a new overseas site of manufacture that performs the secondary steps of analysis and testing.
Background
The site has not been involved in any steps of manufacture for this product previously. The site has been audited by an APVMA-authorised GMP auditor for analysis and testing of this product.
Application requirements
A variation of this nature is considered as a prescribed variation. The product registrant would need to hold current and appropriate GMP evidence for the new site of manufacture, but this does not need to be supplied to the APVMA. The holder submits a declaration to the APVMA that the proposed new site of manufacture has appropriate GMP certification.
What you should do
If you want to add one or more overseas sites of manufacture for a veterinary product for secondary steps of manufacture:
You will be redirected to the Online Services Portal to log in. You will be able to select the appropriate modules once you have generated the decision ID.
f) I want to vary the site of manufacture for my veterinary product and the variation involves the addition of an overseas site of manufacture that performs a primary step/s of manufacture (a concurrent removal of local or overseas sites of manufacture can be combined with this pathway)
See the specific guidance available for this type of variation.
g) I want to vary the site of manufacture for my veterinary product and the variation involves the transfer of a manufacturing site for immunobiological products
Specific guidance material is available for immunobiological products.