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
Variation to an overseas site of manufacture for veterinary products (excluding immunobiological products), where the change involves the addition of an overseas site involved in a primary step of product manufacture is processed as either:
a prescribed variation (Item 13A)
OR
a non-technical variation (Item 12).
A primary step includes all steps that result in direct contact with the veterinary chemical product, and excludes:
labelling or relabelling or secondary/supplementary labelling
secondary packaging
storage
release for supply
analysis and testing: any form of physical or chemical testing.
Is a prescribed variation (Item 13A) or a non-technical assessment (Item 12) required for my site change?
The addition of an overseas site of primary steps of manufacture will usually be processed as a non-technical application (Item 12). The proposed new site must hold acceptable evidence of overseas GMP compliance, and this will be assessed as part of the Item 12 application.
In limited circumstances, the addition of an overseas site of primary steps of manufacture can be made as a prescribed variation (Item 13A). A prescribed variation can be submitted when the proposed site of manufacture is already recorded as a site of manufacture for another veterinary product with the same holder. The proposed site must have appropriate GMP certification.
I want to add an overseas site for primary steps of manufacture and:
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.
In addition, the proposed new site must already be recorded on the register with the APVMA for the same steps for another registered product with the same holder.
It is the product holder’s responsibility to ensure that their product is manufactured 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 the APVMA has not notified you of a proposal to refuse 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 is recorded with the APVMA as a site of manufacture for the same primary steps of manufacture for another product for which you are the holder. The name and product number of the registered reference product should be provided.
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 (GMP)
You will need to hold GMP evidence for each proposed site. This is not required to 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:
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 primary 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.
I declare that the proposed new site of primary steps of manufacture is recorded on the register as a site for the same primary steps of manufacture for my registered product [provide the product number].
Example
Objective
An application is made to vary a flea and heartworm spot-on veterinary chemical product to include a new overseas site of manufacture that performs all the steps of manufacture.
Background
The site has not been involved in any steps of manufacture for this product previously. The product is part of a suite of flea and heartworm spot-on products for dogs and cats. The holder has recently added this overseas site of manufacture for one of the products in the suite, through an Item 12 application, and now is applying to add the site of manufacture for all their related products.
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.
The applicant would need to nominate the name and product number of the first product varied under an Item 12 application.
What you should do
If you want to add one or more overseas sites of manufacture for a veterinary product (excluding immunobiological products) and an Item 13A is required:
You will be redirected to online services to log in.
A non-technical assessment is required (Item 12)
Timeframe and fees
The fee for a non-technical variation (Item 12) is a fixed fee of $2018. The timeframe is three months.
This application type is 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 five months.
What you need to provide
A non-technical variation 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 $2018 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.
Evidence of GMP.
The application should include an information list that includes the details for all the information that has been provided in support of your application. If you are unfamiliar with the process then you should consult the guidance for preparing information lists.
If any of the information provided is subject to limits on use then you must provide consent for use of that information for your application.
Evidence of Good Manufacturing Practice (GMP)
You will need to provide Good Manufacturing Practice (GMP) evidence for each proposed site. 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:
When providing GMP evidence you should ensure it is valid for an appropriate amount of time that will not expire during the determination of the application.
Some veterinary chemical products may be available overseas without registration, but require registration with the APVMA to be sold in Australia. In this situation you should contact the Manufacturing Quality and Licencing Team by email to discuss the options, which may include the overseas audit process.
Example
Objective
Application is made to vary a veterinary chemical product, which is not an immunobiological or peptide product, to include a new overseas site of manufacture.
Background
The site has not been involved in any steps of manufacture for this product previously. The site is involved in dry milling of powders, granulation, tableting, packaging, labelling, storage and release for supply.
Application requirements
An application of this nature is considered under a non-technical variation.
You would need to provide current and appropriate GMP evidence for both new sites of manufacture. Where the GMP evidence is category based, it should cover the relevant steps of manufacture for that category of product (eg paste, injectable). The GMP evidence provided will be assessed as part of the non-technical Item 12 evaluation.
What you should do
If you want to add one or more overseas sites of manufacture for a veterinary product (excluding immunobiological products) and a non-technical assessment (Item 12) is required:
You will be redirected to online services to log in.
