Veterinary Manual of Requirements and Guidelines - Vet MORAG

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Category 9 Application

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 9 application as:

Application for a listed registration of a chemical product containing an approved active constituent and approval of a product label for which an established standard has been approved in accordance with section 56D of the Code.

Products eligible for listed registration under Category 9 are those that meet all the criteria of a relevant Standard for listed registration. Any variations in chemistry or labelling from the Standard render the product ineligible for listed registration.

Standards for listed registration become effective once they have been approved by the Minister and placed as a schedule to a Regulation made under section 56C of the Agvet Code. The Standards will be available on the APVMA website.

Category 9 applications do not require assessment of any data.

2.   REQUIREMENTS

When making a Category 9 application, applicants must provide:

2.1.   Application form

The application form (KP25F23) is available on the APVMA website.

2.2.   Label

The APVMA does not approve the label for products given listed registration, therefore applicants are not required to submit a draft label for approval.

The relevant Standard for listed registration provides information on the requirements with which the marketed label must comply.

2.3.   Fee and timeframe

The fee for a Category 9 application is $1,195.

The timeframe is three months.

3.   EXAMPLES

Example 1: Application is made for listed registration of a product which contains only the active constituents described in the Standard for listed registration of products containing those active constituents, and a label that contains only the information and instructions as per the label included in the Standard.

This application would be assessed under Category 9.

Example 2: Application is made for listed registration of a product which complies with a Standard, but the applicant wishes to make statements on the label additional to those allowed under the Standard.

An application of this nature would be assessed under Category 5, 7 or 10 depending on the nature of the additional label statements.

Alternatively, the applicant may request the APVMA to extend the scope of the Standard to include the additional label statements.

Example 3: Application is made for listed registration of a product which contains active and non-active constituents and label claims which comply with a Standard, but the applicant wishes to include additional active or non-active constituents, and/or wishes to extend the claims for the product.

An application of this nature would be assessed under Category 5, 7 or 10 depending on the nature of the additional active and non-active constituents, and/or label claims.

Alternatively, the applicant may request the APVMA to extend the scope of the Standard to include the additional active and non-active constituents, and/or claims.

FOOTNOTES

  1. 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.
  2. Sites of product manufacture include any subcontractors engaged in a step of manufacture including formulating, filling, packaging, labelling and analysis or testing.

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

  • inserted notice that this category is currently unavailable.
1 July 2007

Fourth edition

  • removed the requirement to provide a draft label in paragraph 2.2
  • minor text changes