Category 12 Application
Minor variation to label and/or product details, where no technical data are required.
Schedule 6 of the Agvet Code Regulations describes a Category 12 application as:
Application to vary particulars or conditions of registration or label approval if:
- the variation is to allow a minor change; and
- no data of a technical nature is required.
A Category 12 application involves variations to the product label or product details1 which do not require submission of data for technical assessment. If a label must also be varied as a result of a variation to product details, this will be done as part of that application and a separate application to vary the label will not be required.
1.1. Application types
The following types of agricultural applications are eligible for assessment under Category 12:
Variation to product label
- minor variation to the product name, where technical assessment is not required
- any other variation to the layout (including colour) or wording of the label, other than those eligible for a Category 13 application, or permitted without an application under Permit 6868
- any other label variation where no data of a technical nature are required.
Variation to product details
- additional pack sizes for a registered product, where product details otherwise remain unchanged and further technical assessment is not required
- minor variation to the formulation where no technical assessment is required
- variation to the site of manufacture (site of formulation) of a product2 if the new site is in Australia and licensed by the APVMA for the type of product and steps of manufacture involved, the product details otherwise remain unchanged and further technical assessment is not required
- any other variation to product details where no data of a technical nature are required.
When making a Category 12 application for variation to the registration of a product, applicants must provide:
- one unbound copy of the Application Form (refer to paragraph 2.1)
- the varied product label (refer to paragraph 2.2)
- the relevant fee (refer to paragraph 2.3).
If the application is for a label variation only (except copying of uses of a reference product or additional pack size), applicants should use the specific application form (KP25F07). There is no requirement to supply formulation details or an Application Overview in this form.
A separate application form (KP25F06) for variation to product details (eg minor formulation change, additional pack size or change to site of manufacture), or to copy uses of a reference product. This document is a combined Application Form and Overview. It includes formulation details.
2.1.1. Electronic Application Registration System (EARS) submissions
In May 2007 the APVMA released EARS client software which enables applicants to electronically complete and submit Category 12 applications to the APVMA.
To gain access and use of the EARS software client applicants must complete the EARS user enrolment form.
Once enrolled, applicants are supplied with a username and account and CD with the EARS software client. Account holders are able to use EARS to submit electronic applications over a secure encrypted internet connection.
Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).
Applicants may provide the draft label as either:
- two copies of the text label (TXL) printed on paper; or
- an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.
The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.
All parts of the draft label must be in accordance with the latest editions of the:
- Labelling Code
- Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
- Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).
After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.
Refer to Label Approval Process in Volume 5 for further information.
The fee for a Category 12 application is $875.
The timeframe is three months.
If an applicant wishes to apply for changes to the particulars, conditions, or approved label for a product, and if:
- the application would normally be made under Category 12; and
- the applicant wishes to make identical changes to multiple products;
- the applicant should apply for the changes under Category 14. Under Category 14, the APVMA will charge a fee constructed from the screening fee and finalisation fee, which is considerably less expensive than if the applicant makes multiple applications under Category 12.
An example is where a registrant applies for approval for change in the site of manufacture for the registrant’s entire range of products.
Full details are set out in Category 14.
2.4. Data protection
Data are not required for Category 12 applications, therefore a data list is not required.
However, applicants applying under Category 12 to copy uses from an approved label of another product may need to refer to data relied on by the APVMA to register the reference product. The reference product may also have required access to protected data in relation to the active constituent/s or its reference product. Where the applicant is not the authorising party for the data used to approve the active constituent/s or register the product/s, the applicant must obtain consent for use from the relevant authorising parties. Applicants can determine whether they are using protected data by checking the product details on the product search facility on the APVMA website.
3.1. Variation to product label where no technical assessment is required
3.1.1. Minor variation to the product name
Applications for variations to the product name may be made under Category 12 provided they are minor and not for the purpose of creating a new additional product (repack) for marketing purposes. Application for registration of a new additional product must be made under Category 8 (repack), and a new APVMA product number will be allocated for the additional product. Applications which propose variations to the distinguishing features of the product name, and which do not involve variations to the formulation details, should be made under Category 8 (repack).
A variation to the product name under Category 12 will not result in a change to the APVMA product number.
Variations to the product name:
- must be minor
- must not change the distinguishing feature (words or numbers) of the name
- must not affect the meaning or emphasis of any claim or instruction.
Applicants should refer to Volume 5: Labelling, for further guidance on product names and prohibited statements.
Examples of Category 12 minor variations to a product name include:
- removal or addition of a company name (for example as a result of a company name change) that does not affect the distinguishing words or numbers in the product name
- removal or addition of punctuation marks, letters or words that does not affect the distinguishing words or numbers in the product name.
3.1.2. Variation to the product label, consistent with an identical or closely similar reference product
Application to vary the product claims and other label instructions or information, where this is consistent with an identical or closely similar reference product, may be made under Category 12 provided that further technical assessment is not required and there are no data protection issues.
For this type of application under Category 12, the technical assessment has already been conducted for an identical or closely similar reference product. See Category 6, 7 and 8 (image products and repacks) and see Definition of terms used in this manual in Volume 2 for definitions of ‘closely similar’, ‘image products’ and ‘repacks’.
Applicants must provide the name and number of the reference product.
3.1.3. Variation to the label layout (including colour) or wording
Applications of this nature are for any other variation to the layout (including colour) or wording of the label, other than those eligible for a Category 13 application, or permitted without application, under Permit 6868.
3.2. Variation to product details where no technical assessment is required
3.2.1. Additional pack size
Applications to approve additional pack sizes may be made under Category 12 provided that further technical assessment is not required.
Applications of this nature are to add a new pack size to a registered product where all other product details (including name, concentration and standard for each ingredient; release and expiry specifications; immediate container specifications; shelf life; and site of product manufacture) are unchanged.
Applicants must provide a copy of the proposed marketed product label, including the additional pack size, for approval.
Note that assessment of stability data will be required if there are changes to the packaging material or closure system of the immediate container. Stability data may also be required for proposed pack sizes that are unusually large. If stability data are required then the application will be assessed under Category 14.
Registration of a smaller or larger pack size outside a range of approved pack sizes may occasionally require toxicology and/or OHS assessment. Such applications will be assessed under Category 14.
3.2.2. Minor variation to the product formulation where no technical assessment is required
Applications of this nature involve minor variations to formulation details where the variation does not require assessment of data for the APVMA to continue to be satisfied of product quality, safety and efficacy.
Examples of such variations are small amendments to the concentrations of non-active constituents or substitution of one very similar non-active constituent for another.
Applicants should provide argument as to why the change would not affect the above-mentioned matters (ie the changes are very small/minor and would not affect the physico-chemical properties of the product).
3.3. Other variations where data of a technical nature are not required may be made under Category 14
Applications for other minor variations to product details or labels, where technical assessment is not required, other than those variations specified in this chapter (Category 12) or Category 13, or allowed without application under the current Permit 6868, may be made under Category 14 as a non-technical assessment.
Details of variations permitted without an application under Permit 6868 can be found on the APVMA website at http://permits.apvma.gov.au/PER6868.PDF
Applicants must provide details of the proposed product variations in the application overview. Label changes must be highlighted on the submitted labels.
- Product details include details of the formulation (including names, concentrations and standards for each constituent), release and expiry specifications, manufacturing process, immediate container specifications, shelf life, and site of product manufacture.
- Sites of product manufacture include any subcontractors engaged in a step of manufacture including formulating, filling, packaging, labelling and analysis or testing.
|Revision Date||Description of Revision|
|1 July 2005||First edition|
|1 October 2005||
1 December 2005
|1 April 2006||
|1 July 2007||