Agricultural Manual of Requirements and Guidelines - Ag MORAG

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Category 13 Application

Minor, non-technical variation to label and/or product details, required by the APVMA.

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 13 application as:

Application to vary particulars or conditions of registration or listed registration or label approval if:

  1. the variation is to allow a minor change; and
  2. no data of a technical nature is required; and
  3. the variation is a change required by the APVMA.

The following types of applications are eligible for assessment under Category 13:

Note that Permit 6868, which is available on the APVMA website at http://permits.apvma.gov.au/PER6868.PDF, allows registrants to make specified label changes without application to the APVMA. Those specified label changes would otherwise require an application under Category 12 or 13 if they were not included in the scope of Permit 6868. Category 13 applications may also include variations permitted under Permit 6868.

2.   REQUIREMENTS

When making a Category 13 application to vary the particulars or conditions of registration or listed registration or label approval, applicants must provide:

2.1.  Application Form

The specific Category 13 application form (KP25F07). There is no requirement to supply formulation details or an Application Overview in this form.

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 13 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.

2.2.   Label

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:

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.

2.3.   Fee and timeframe

There is no fee for a Category 13 application.

The timeframe is three months.

3.   EXAMPLES

3.1.   Variation to the wording of an instruction or other label information specifically required by the SUSDP or FAISD Handbook

Example 1: Application is made for a variation to the product label to change the signal heading in accordance with a change to the scheduling of the active constituent in the SUSDP. The applicant also wishes to update company contact details on the label.

An application of this nature would be eligible for assessment under Category 13. Updating of the company contact details alone is permitted under Permit 6868.

Example 2: Application is made for a variation to the product label to change the safety directions to comply with the current edition of the FAISD Handbook. The applicant also wishes to apply for an additional pack size.

The proposed change to label safety directions alone would be eligible for assessment under Category 13. However, the proposed additional pack size is outside the scope of Category 13. This application, involving both variations, would be assessed under Category 12, or Category 14 if the proposed pack size required submission of data for technical assessment.

3.2.   Variation to the product label as an outcome of an APVMA reconsideration (chemical review)

Example 3: Application is made for a variation to the product label to include altered withholding periods and new restraint statements as a consequence of the outcome of a reconsideration of the active constituent by the APVMA.

An application of this nature would be eligible for assessment under Category 13.

3.3.   Minor label variation required and specified by the APVMA

Example 4: Application is made for a variation to the product label to extend the product’s use to all States following publication of an APVMA Gazette Notice to this effect.

An application of this nature would be eligible for assessment under Category 13.

Example 5: Application is made for a variation to the product label to update the label to conform to the Labelling Code. In addition, a variation to colour or layout of the label is requested for marketing purposes.

The proposed variations to the label to conform to the Labelling Code alone would be eligible for assessment under Category 13. However, the proposed marketing variations are outside the scope of Category 13. This application, involving both variations, would be eligible for assessment under Category 12.

REVISION HISTORY

Revision Date Description of Revision
1 July 2005 First edition
1 October 2005 Second edition
  • hyperlinks inserted to Labelling Code, SUSDP and FAISD handbook.
1 April 2006 Third edition
  • no changes.
1 July 2007

Fourth edition

  • add new paragraph 2.1 to clarify that an application form is required
  • add new paragraph 2.2.1 re EARS
  • paragraph 2.2: revised label requirements
  • minor text changes.