Category 18 Application
1. DEFINITION
Schedule 6 of the Agvet Code Regulations describes a Category 18 application as:
Application to vary particulars or conditions of an approved active constituent.
1.1. Variations to active constituents used in veterinary medicines will usually be done under Category 14
Category 18 applications involve chemistry assessment only and are generally not relevant to veterinary medicines. Variations to approved active constituents in veterinary medicines will usually be done under Category 14, as part of a variation to the particulars or conditions of the product. For further information, refer to the section on variation to active constituents in Category 14.
However, active constituents that are used in ectoparasiticide products and also agricultural chemical products, for which there is no APVMA-recognised compendial standard (refer to tables in Category 17), may be eligible for assessment under Category 18.
2. REQUIREMENTS
When making a Category 18 application for variation to the particulars or conditions of active constituent approval, applicants must provide:
- one unbound copy of the combined Application Form and Overview (refer to paragraph 2.1)
- one bound copy of each of the relevant data Parts (refer to paragraph 2.2)
- the relevant fee (refer to paragraph 2.3).
- data list (refer to paragraph 2.4).
2.1. Combined Application Form and Overview
The Application Form and Application Overview have been combined into a single document (KP21_F21 (RTF, 272kb)). A single unbound copy of the combined document must be provided to the APVMA.
The Application Form is divided into separate sections for application for registration of the product and approval of the active constituent.
The Application Overview section of the combined document is in the form of a template. Applicants may use this template, or may submit their own Application Overview although this must conform to the instructions and format provided in Part 1 – Application overview in Volume 3.
Sub-parts 1.1–1.2 of the Application Overview must both be completed.
2.2. Data
Data requirements for Category 18 applications are as follows:
| Description | Data Part |
|---|---|
| Application Overview | Part 1 |
| Chemistry and Manufacture data for the active constituent | Part 2 |
Detailed Part 2 data requirements can be determined by referring to Volume 3: Data requirements and guidelines.
2.3. Fee and timeframe
The fee for a Category 18 application is $1,005.
The timeframe is five months.
2.4. Data protection
Data provided with an application to vary the particulars or conditions of approval of an active constituent are ineligible for data protection. Because there are no requirements on the APVMA to publish the details of Category 18 applications, a data list is not required.
REVISION HISTORY
| Revision Date | Description of Revision |
|---|---|
| 1 July 2005 | First edition |
| 1 October 2005 | Second edition
|
| 1 April 2006 | Third edition
|
| 1 July 2007 | Fourth edition
|