There are a range of changes to details of actives, products and labels that can be made as prescribed variations and notifiable variations under the Agvet Code Regulations. Prescribed variations are listed in the Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019. Notifiable variations are listed in the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2019.
Some other changes to registered products and approved labels can be made without notifying the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Prescribed variations – changes to manufacturers of veterinary products
Australian sites
You can change the name and address of an Australian manufacturer of a registered veterinary chemical product as a prescribed variation (including the adding and removing of Australian manufacturers). Where the registered veterinary chemical product must be manufactured under a Good Manufacturing Practice (GMP) licence, the new manufacturer must also hold a GMP licence. These changes are made using an Item 13A application.
Overseas sites
You can change the name of an overseas manufacturer of a registered veterinary chemical product that requires GMP as a prescribed variation using an Item 13A application.
You can also change the address of an overseas site of secondary steps of manufacture (e.g. packaging and labelling) of a registered veterinary chemical product as a prescribed variation. Changes to a site of manufacture for primary steps of manufacture can be made as prescribed variations in limited circumstances. The new site is required to have appropriate GMP certification.
Further guidance
For further guidance on how to apply for site of manufacture changes for Australian and overseas sites, please refer to the tailored guidance for applicants 'I want to vary the sites of manufacture'.
Prescribed variations – changes to non-active constituents (excipients)
In some cases an application for the variation of one or more non-active constituents (excipients) of a chemical product can be submitted to the APVMA as a prescribed variation, using an Item 13A application.
In certain circumstances, holders of registered chemical products may apply to the APVMA to replace one or more non-active constituents (excipients). The timeframe for the APVMA to process these applications is one month. If the APVMA has not made a decision on the application within one month, the APVMA is taken to have made a decision to vary the relevant particulars as proposed in the application, noting that variation takes place when the APVMA makes the resultant changes to the Record of Approved Active Constituents for Chemical Products or Register of Agricultural and Veterinary Chemical Products or relevant APVMA file, as the case may be.
Applications for this type of variation can only be made by holders or their nominated agents. Authorised agents will not be able to make this type of application. Applicants are required to make statements about the evidence they hold about the physical properties and storage stability of the chemical product, with additional information required for veterinary chemical products. Specific details of the information required to be in such an application can be found in Part 4A of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
As mentioned, applicants must make a statement that they hold evidence of certain matters concerning the product. It is inherent to such a declaration that the applicant knows the formulation of the product either directly or by consent. It is important for applicants to be aware that the provision of false or misleading information may lead to a prosecution under the Criminal Code Act 1995 and may also result in the suspension or cancellation of an approval or registration, amongst other things, under the Agricultural and Veterinary Chemicals Code, as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. The excipient/s being replaced must be named in the application, as they are listed in the Register, in order to assist the approval process.
There are a range of limitations on the scope of the changes that may be made by prescribed variation. These include the exclusion of certain product types or dose forms, restrictions on constituents that are nanomaterials and materials of human or biological origins, and limitations to the number of constituents that can be changed. It is important to note that all the requirements of the prescribed variation must be met, and a declaration to this effect is required as part of the application process.
The decision tree includes a series of questions to help applicants decide whether the change to excipients for their product can be made as a prescribed variation.
The following examples provide some insight into the scope of the possible variations.
1. The holder wishes to replace the non-nano non-human or animal origin anhydrous magnesium sulfate non-active constituent in their current formulation with non-nano non-human or animal origin magnesium sulfate heptahydrate non-active constituent in their registered oral electrolyte product without change to the formulation type. The Poisons Standard signal words are unchanged.
This would be an Item 13A (if anhydrous magnesium sulfate and magnesium sulfate heptahydrate are considered to have the same pH, dissolution profile, hydrophilic or hydrophobic behaviour and hygroscopic behaviour).
2. The holder wishes to replace the non-nano non-human or animal origin butylated hydroxytoluene antioxidant non-active constituent in their current formulation with non-nano non-human or animal origin alpha-tocopherol antioxidant non-active constituent in their registered injectable product without change to the formulation type. The Poisons Standard signal words are unchanged.
This would not be an Item 13A (injectable products are excluded).
Notifiable variations – changes to agricultural and veterinary products and actives
Certain variations to approvals or registrations are determined by the APVMA to be notifiable variations. A holder or their nominated agent may simply apply via the decision tree giving notice of one or more notifiable variations. There is a $50 fee per written notice.
| Item | Notifiable variation of relevant particular | Approval or registration |
|---|---|---|
| 1 | A variation of the name of the manufacturer of an active constituent for a chemical product | any approval of an active constituent |
| 2 | A variation of the distinguishing name of a chemical product | any registration of a chemical product |
| 3 | A variation of the net contents of an agricultural chemical product, but only if: (a) the variation will not result in the instructions for use, or disposal, of the product or containers for the products, being modified or affected; and (b) the net contents is in the range recorded in the Register for the product | any registration of an agricultural chemical product |
| 4 | A variation of the instructions for a use of a chemical product if: (a) the variation is to remove the use of the chemical product from the instructions; and (b) the variation of the instructions will not otherwise modify or affect the instructions for another use of the product | any registration of a chemical product |
| 5 | A variation of either or both of the following particulars: (a) the name of a manufacturer of a chemical product; (b) the address of each site at which the product is manufactured by a manufacturer | any registration of a chemical product that is prescribed under subregulation 59(1) |
| 6 | A variation of an approved label as a result of a notifiable variation mentioned in items 3 and 4, but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product | any approval of a label for containers of chemical products |
| 7 | A variation of the name of a chemical product that is to appear on an approved label as mentioned in paragraph 17(1)(b) of the Regulations, but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product | any approval of a label for containers of chemical products |
| 8 | A variation of one or more constituents of a chemical product if: (a) the variation is to replace one or more constituents with a constituent or constituents listed for the product in an interchangeable constituent determination; and (b) in the case of a product that has 9 or more constituents entered in the Register for the product – the variation is to no more than 25% of the number of constituents entered in the Register for the product; and (c) in the case of a product that has less than 9 constituents entered in the Register for the product – the variation is to one or 2 of the constituents entered in the Register for the product | any registration of a chemical product |
| 9 | A variation to the address of a site at which the approved active constituent is manufactured by the manufacturer if there is no physical change of location | any approval of an active constituent |
| 10 | A variation to the name of any other registered products referred to within the instructions for use on the label (provided the referred to product has the same APVMA distinguishing number). This Item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product | any registration of a chemical product; approval of a label for containers of a chemical product |
| 11 | A variation to the instructions for storage and disposal of containers of products, in line with the relevant requirements for the type of container as specified in the Agricultural Labelling Code or Veterinary Labelling Code made by the APVMA. But only if the variation will not result in other instructions for use being modified or affected. This Item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product | any registration of a chemical product; approval of a label for containers of a chemical product |
| 12 | A variation to safety directions and first aid instructions appearing on a label to reflect the current FAISD Handbook. This Item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product | any registration of a chemical product; approval of a label for containers of a chemical product |
| 13 | A variation of the net contents of a veterinary chemical product but only if: (a) the variation will not result in the instructions for use, or disposal, of the product or containers for the product, being modified or affected; and (b) the net contents is in the range recorded in the Register for the product. This Item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product | any registration of a veterinary chemical product; approval of a label for containers of a chemical product |
Prescribed and notifiable variations for suspended approvals and registrations
Holders may also make prescribed or notifiable variations to suspended active constituents, products or labels provided the variation relates to the reason for the suspension (in accordance with s 43(5) of the Agvet Code).
Variations that can be made without notifying the APVMA
Some changes can be made to registered products and approved labels without the holder needing to notify or make an application to, the APVMA. These are changes to things that are not relevant particulars or conditions of registration, do not alter the way the product is used, and do not contradict existing information on the product label.
Product changes that the APVMA does not need to be notified of include changing the:
- source of active constituent in a registered product to a different approved source of active constituent. It is a condition of registration that the active constituent must comply with the APVMA Standard and be manufactured at the site listed in the record of approval active constituents
- packaging material of a registered product. It is a condition of registration that products will be supplied in suitable packaging (regulation 18 of the Agvet Code Regulations).
Label changes that the APVMA does not need to be notified of include:
- corrections to spelling mistakes and typographical errors
- updating a Mode of Action group in line with the relevant Labelling Code
- updating reference to a product holder on a label if this has changed (for example, in the resistance management strategy)
- compatibility statements for agricultural chemical products (this excludes ‘incompatibility’ statements that have been required by the APVMA).
Submission using the APVMA Online Services Portal
Applicants can submit changes to the APVMA using the tailored guidance for applicants or the Online Services Portal decision tree which will generate an ID number and direct people to the applicable application form.
The tailored guidance for applicants provides details of what you need to submit and directs applicants to the relevant application form (this includes the generation of an ID number).
An application can be made by:
- the holder
- the nominated agent
- any other person with the written consent of the applicant (not applicable to changes to non-active constituent prescribed variations).
Following submission of the applicable application form, the APVMA will update the register and notify applicants.
Information about fees and timeframes is available on our website.