Category 18 application
Variation to particulars or conditions of an approved active constituent

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.

A Category 18 application is an application by the approval holder of an active constituent to vary the particulars or conditions of approval of the approved active constituent. Examples include changes to the quality of the active constituent or changes to the manufacturing process. Category 18 applications involve chemistry assessment only.

1.1.   Variations to biological active constituents are ineligible for assessment under Category 18

Applications for variations to biological active constituents are ineligible for assessment under Category 18. Variations to biological active constituents have the potential to affect efficacy and/or target crop safety and may therefore require assessments other than chemistry, under Category 25. The APVMA will usually regard a variation to a biological active constituent as a new active constituent.

Applications for variations to active constituents which have toxicological implications are ineligible for assessment under Category 18. Variations to active constituents which require toxicological evaluation or poisons scheduling may be assessed under modular Category 25.

2.   REQUIREMENTS

When making a Category 18 application for 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).

• a 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 (KP25F21) which is available on the APVMA website. 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:

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 $915.

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