Schedule 6 of the Agvet Code Regulations provides statutory definitions of when a proposed product is similar or closely similar to a reference product. To determine the appropriate Item number, you need to first establish whether your product meets the statutory definition of similar or closely similar in relation to your nominated reference product. The following table lists the criteria to assist you through this step:
| Criteria (proposed product compared to reference product) |
Similar | Closely similar |
|---|---|---|
| Same active | Y | Y |
| Same concentration of actives | Y | Y |
Either the non-active constituents in the formulation:
|
N/A | Y |
Either the specifications and physico chemical properties:
|
N/A | Y |
| Formulation type and dosage form are the same | Y | Y |
| Same use patterns and instructions on the label | Y | Y |
| Label claims are the same, fewer or reduced | Y | Y |
| Reference product information is not subject to limit of use of information or the applicant has obtained consent from the owner to use the data from the reference product |
Y | Y |
The following table depicts for each relevant risk area where either:
- a specific ‘assessment’ will apply, or
- where the submission relies on the ‘reference product’.
|
|
Similar |
Closely similar |
|
|---|---|---|---|
|
Risk area by module type |
Item 5 |
Item 6 |
Item 7 |
|
Chemistry |
Assessment |
Assessment |
Reference product |
|
Health |
Reference product |
||
|
Poisons scheduling |
Reference product |
||
|
Residues and trade |
Reference product |
||
|
Environment |
Reference product |
||
|
Efficacy and Safety |
Assessment |
Reference product |
|
|
Non-food trade |
Reference product |
||
|
Special data |
Reference product |
||
Reference product = risk assessment can be satisfied by that previously undertaken on a single reference product.
1. Legislation
1.1. Framework
The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.
The Agricultural and Veterinary Chemicals Act 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.
The Agricultural and Veterinary Chemicals Code Act 1994, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.
The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.
1.2. Statutory criteria
In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:
- Safety (section 5A).
An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:
a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
To satisfy the s 5A criteria, the APVMA considers chemistry and manufacture, health (including poison scheduling and work health and safety), residues, environment and target safety.
- Efficacy (section 5B)
A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.
- Trade (section 5C)
A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.
- Labelling (section 5D)
In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.
The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.
1.3. Application requirements
The Agvet Code, s 8A provides the definition of 'meets the application requirements'.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Parts 2 and 4, sets out the information that must be contained in, or accompany an, application under the Agvet Code.
1.4. Guidelines
The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines that fall under this, for example:
1.5. Applications may be withdrawn
The Agvet Code, s 8D states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.
1.6. Definitions
The following definition of closely similar is contained in Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995.
1.2 When chemical products are closely similar
(3) Subject to cause 1.5, a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if:
(a) the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and
(b) the concentration of the active constituents referred to in paragraph (a) are the same; and
(c) either:
(i) the non active constituents in the formulations of the proposed and reference chemical products are the same, or are equivalent substances, at the same or equivalent concentrations; or
(ii) if the non active constituents in the formulations of the proposed and reference chemical products are neither the same nor equivalent, the differences in the formulations are minor and are not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues; and
(d) either:
(i) the proposed and reference chemical products specifications (including release and expiry limits and test methods) and physico chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) are the same or equivalent; or
(ii) if the specifications and physico chemical properties of the proposed and reference chemical products are neither the same nor equivalent, the differences in the specifications and properties are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues; and
Note for paragraphs (c) and (d): Efficacy, safety and residues data are not required to demonstrate similarity of the proposed chemical product to the reference chemical product.
(e) the dose form and formulation type of the proposed and reference chemical products are the same; and
(f) the use patterns (including target animal species, dose rates, routes of administration and withholding periods) and instructions on the labels of the proposed and reference chemical products are the same; and
(g) either:
(i) the claims on the labels of the proposed and reference chemical products are the same; or
(ii) if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.
1.5 When chemical products are not closely similar, similar or the same
(1) Despite clauses 1.2, 1.3 and 1.4, a proposed chemical product and a reference chemical product are not closely similar, similar or the same if:
(a) the APVMA is required to use information in determining an application in respect of the proposed chemical product; and
(b) the use of the information by the APVMA in determining that application is restricted.
(2) The use of information by the APVMA in determining an application is restricted if the APVMA is restricted from using the information in determining the application by:
(a) Division 4A of Part 2 of the Code; or
(b) Part 3 of the Code.
2. Timeframe and fees
The fee to register a new product that is closely similar to a registered reference product (Item 6) is a fixed fee of $6406. The timeframe is eight months. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.
This application type is subject to an extended assessment period if a section 159 notice is sent requesting additional information. The extended assessment period for an Item 6 application is 12 months.
3. What you need to provide
3.1. Completed online application form
First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.
If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.
3.2. The application fee
You may choose to:
- pay the total fee on submission or
- pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has been accepted.
You can choose to pay by credit card, electronic funds transfer or BPAY.
Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).
3.3. Information list
It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in or accompanying the application – an information list.
Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.
The online application form contains fields to assist applicants in entering the information required to generate the information list.
Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.
3.4. Reference product details
Applicants must nominate one, and only one, registered reference product. Details to provide include the product/active constituent number and the full name of the product/active. Reference products must be agvet chemical products currently registered by the APVMA. Registered chemical products can be searched on APVMA’s product search database.
3.5. Consent for use from the relevant authorising party (if applicable)
Consent for use is required where there is protected information listed for the reference product, unless one of the following exceptions apply:
- the applicant is the authorising party for the data associated with the reference product
- the applicant has obtained consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers
- the protected information is not relevant to the proposed use pattern.
Protected data details are listed in our product search database record for the reference product.
Note: Consent for use applies to all relevant risk areas
3.6. Supporting information
The application must contain, or be accompanied by, information relevant to whether the chemical product meets the safety and efficacy criteria. Applicants should include an explanation why supporting information is not required, if not provided with the application.
3.7. Data requirements
Relevant data for module levels— veterinary chemical products sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together.
To meet the application requirements you will need to provide:
- a completed online application form
- the application fee plus any amount that is due to the APVMA
- supporting information
- an information list
- consent for use, if your reference product has limits on use of information
- e-label.
3.8. Electronic label (e-label)
The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (Agvet Code, ss 5D and 14). Applicants must use the e-label template to submit the label details that the APVMA must take into account.
Introduction to preparing a label and the label approval process provides more detailed information.
4. Examples
4.1. Scenario 1: Registration of a new product that is closely similar to a reference product
4.1.1. Objective
An applicant has applied to register an injectable antibiotic product referencing a registered injectable antibiotic, which has a different formulation composition. The use pattern and target animal species (cats and dogs) are the same as that of the reference product. The applicant has checked the APVMA product search database and has determined that the reference product does not have any protected data.
4.1.2. Application type
The applicant has considered the definition of closely similar and has determined that their proposed product meets the definition in relation to the nominated reference product. The applicant submits chemistry and manufacture data for assessment.
4.1.3. Assessment
The APVMA will conduct assessments to determine if:
- the proposed product meets the definition of closely similar when compared to the nominated reference product
- the chemistry and manufacturing data submitted demonstrate formulation stability in the proposed container.
4.1.4. Timeframe and fees
The fee to register this product is a fixed fee of $6406. The statutory timeframe will be eight months but may be extended to 12 months if further information is required by the APVMA during assessment.
4.2. Scenario 2: Registration of a product which is submitted as closely similar but is determined in assessment not to meet the statutory definition of closely similar
4.2.1. Objective
An applicant has applied to register a pour-on product referencing a registered pour-on. The use pattern and the rate of active is the same as that of the reference product. The applicant has checked the APVMA product search database and confirmed that the reference product does not have any protected data.
4.2.2. Application type
The applicant has considered the definition of closely similar and has determined that their proposed product meets the definition in relation to the nominated reference product. The applicant submits chemistry and manufacture data for assessment.
4.2.3. Assessment
On examination the APVMA determines that there are significant differences in the non-active ingredients between the proposed and reference product. In particular, the combination of the non-actives in the proposed product are so different they change the viscosity of the pour-on. The proposed product is a topical application which is a highly formulation-dependent dosage form. Variations in formulations and specifications can affect bioavailability and pharmacokinetics of the active constituents, and, therefore, affect efficacy, target animal safety and residues. The APVMA determines that the proposed product is not closely similar and proposes to refuse the application.
4.3. Scenario 3: Registration of a product that is closely similar but the reference product has limits on use
4.3.1. Objective
An applicant has applied to register an oral feed additive using a registered oral feed additive as the reference product. The active in the product is to be added to feed at the same rate as the reference product and fed to pigs and chickens at the same dose rate.
4.3.2. Application type
The applicant has considered the definition of closely similar and has determined that their proposed product meets the definition in relation to the nominated reference product. The applicant does not submit any further data for assessment. The application has been submitted under Item 6 and a reference product has been nominated to address the risk areas.
4.3.3. Assessment
On examination the APVMA notes that the reference product has limits on use of information applying to efficacy, target safety and residues for pigs and chickens listed in the APVMA product search database record for the reference product. The proposed use for pigs and chickens does not meet the requirements of an Item 6 application as the reference product has relevant protected information. See the criteria matrix in the introduction section for further information. The applicant has not provided consent for use from the holder of the limits on use data relevant to pigs and chickens.
4.3.4. Revised application type
The applicant should instead either:
- provide consent from the holder of the protected data when submitting under an Item 6
- submit the application as a modular assessment—new product (Item 10) as the new product requires technical assessment of efficacy, target safety and residues.
5. Start an application
To register a product which contains a combination of existing actives in registered products (Item 6):
You will be redirected to online services to log in.