This content is current only at the time of printing. This document was printed on 26 January 2020. A current copy is located at https://apvma.gov.au/node/12846
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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 at regulation 19AF and notifiable variations at regulation 19AE of the Agricultural and Veterinary Chemicals Code Regulations.
Prescribed variations—changes to manufacturers of veterinary products
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 GMP licence, the new manufacturer must also hold a GMP licence. These changes are made using an item 13A application.
You can also 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.
Please note: if you are changing the name and street address for the overseas manufacturer of your product or to include a new site, these changes do not qualify as a prescribed variation. These changes will continue to be processed as product variations and must be submitted through an item 14 application.
Prescribed variations—changes to non-active constituents (excipients)
As of 1 July 2016, in some cases 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 limited 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 (1) month. If the APVMA has not refused the application within one (1) month, the variation takes effect.
Applications for this type of variation can only be made by holders or nominated agents. Authorised agents will not be able to make this type of application. Applicants are required to make statements about evidence they hold about the physical properties and storage stability of the product, with additional information required for veterinary chemical products. The details of the information applicants must hold are at regulation 8AFB of the Agvet Code Regulations.
Applicants must be able to declare that they know certain details concerning the constituents and the product. This is likely to mean that they will need to know the formulation of the product either directly or by consent. If they do not know the full formulation details, the APVMA may find it difficult to be satisfied that the applicant is in a position to make the declaration. 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 registrant 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 registrant 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 changes to registrations or approvals can be submitted as a notifiable variation. Notifiable variations are not an application. There is a $50 fee for each notification.
|Notifiable variation of relevant particular||Approval or registration|
|Name of the manufacturer of an active constituent||Active Approval|
|Address of a site at which the approved active constituent is manufactured by the manufacturer if there is no physical change of location||Active Approval|
|Distinguishing name of a chemical product (name in the register)||Registration & label approval|
Net contents of both agricultural and veterinary products if:
|Registration & label approval|
The label name (marketing name)
Removal of a use from the product label
|Registration & label approval|
|Name and site address of each manufacturer (prescribed chemical products, regulation 59(1))||Registration|
The name of any other registered products referred to within the instructions for use on the label
The instructions for storage and disposal of containers of products
Note: This is to facilitate updating labels that may not have been seen by the APVMA for many years. Wording of instructions are either mandated by legislation or acceptable wording should be in line with the relevant Labelling Codes.
This does not cover changes to storage condition statements for products that have been assessed by the APVMA and impact on the stability of the product and therefore efficacy and safety eg. changes to storage temperature, protect from light, do not freeze, avoid storing for prolonged periods in direct sunlight. Changes to these statements require assessment.
|A variation to the safety direction and first aid instructions appearing on a label to reflect the current FAISD handbook, but only if the 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||Label approval|
|A variation of one or more constituents (interchangeable constituent determination) in accordance with the relevant legislative instrument||Registration|
Submission using online services
You can submit changes to the APVMA using the online services decision tree. The decision tree will generate an ID number and direct people to the applicable application form.
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 can be found here.