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Interchangeable Constituent Determination—Item 29
From 1 July 2016, the APVMA is able to determine that specific non-active constituents (excipients) may be substituted for one another without assessment. These determinations can apply to a single chemical product, a range of chemical products or a class of chemical products. These are referred to as Interchangeable Constituent Determinations.
Applications for excipients to be considered for inclusion in an Interchangeable Constituent Determination will be made via a new application item, Item 29, by a person making an application under r19AEB. The APVMA also has the power to make Interchangeable Constituent Determinations in its own right with no application.
Initially, the Item 29 application will only be available as a manual form. This allows applications to be submitted by individuals and entities that are not registered users of the online portal. The application fees and timeframes will be based on the modular system for assessment (as per applications under items 1, 2, 10 or 25), and limits apply on the use of information provided in support of the application.
The APVMA strongly encourages prospective applicants to contact the APVMA to discuss their proposal for an Interchangeable Constituent Determination. The APVMA and the applicant can discuss the scope of the proposal (eg the number of constituents being considered and the purposes in the product/s), identify the technical requirements (eg what is known about the constituents in relation to the safety, efficacy and trade criterion the APVMA will be assessing against) and the modules necessary for each application. The meeting might take the form of formal Pre-application Assistance (PAA). An informal process may also be adopted, since there is no rebate for the PAA fee upon submission of an Item 29 application.
Interchangeable Constituent Determinations are made by legislative instrument. Allowable substitutions will be available across industry, and registrants will need only make a Notifiable Variation to the APVMA to apply an approved Interchangeable Constituent to their product. Noting there are no Interchangeable Constituent Determinations yet in place, no application pathway has been created.
Criteria for an Item 29 application
An application must specify:
- the identity of the constituents (both the common name and IUPAC name and the Chemical Abstract Service number)
- the purpose of the constituents in the product or class of chemical products
- any requirements for the constituents (minimum purity or other quality specifications).
It must also:
- include information to confirm that the constituents to be interchanged are not active constituents of the product/s
- not introduce material of human or animal origin into the product/s
- not vary the signal words required by the current Poisons Standard to be on the label of the product/s
- not change the formulation type of the product/s
- the product/s must continue to meet the safety, trade, efficacy and labelling criterion after the interchange of constituents and the APVMA may specify conditions to ensure this.
Where the APVMA proposes to vary or revoke an interchangeable constituent determination, the APVMA must publish a notice about the variation or revocation, and consider any submissions received.
How to make an Item 29 application
To make an application under Item 29 you must?send an email to?APVMA Enquiries and provide:
- your contact details (name, address, phone and email)
- who you are representing in the proposed application (eg company, industry group)
- the product/s or class of product/s
- the purpose of the excipients in the product/s.
You will be contacted after the APVMA receives this information and, following a background discussion, a meeting may be organised to determine the scope of the likely application (including expected data requirements and module time frames and fees). This might take the form of a Pre-Application Assistance meeting, unless it is a simple application and PAA is not considered necessary.
The APVMA will provide you with the manual Item 29 application form, which you can complete and return to the APVMA.
The APVMA will assess the application and decide whether it satisfies the statutory criteria. The Interchangeable Constituent Determination will be published as a publicly accessible legislative instrument.
The current data guidelines are available online.
Further enquiries can be directed to APVMA Enquiries:
Phone: +61 2 6770 2300
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001