Category 16 Application
Approval of a new active constituent: Limited toxicology assessment.
1. DEFINITION
Schedule 6 of the Agvet Code Regulations describes a Category 16 application as:
Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment.
A Category 16 application is for approval of a new active constituent, where a limited assessment of toxicology data is required in addition to assessment of chemistry data.
1.1. Application types
The following are examples of new active constituents which may be eligible for assessment under Category 161:
- an active constituent for which the applicant has provided an acceptable comprehensive toxicological assessment report. In order to be acceptable, comprehensive toxicology reports must be of a quality acceptable under the Organisation for Economic Co-operation and Development (OECD) and dated from 1 July 2005
- biological active constituents including:
- biopesticide active constituents (eg pheromones and other semiochemicals)
- microbial pest control products (bacteria such as new strains of Bacillus thuringiensis, protozoa, viruses, and fungi)
- direct-fed microbial and enzyme active constituents.
2. REQUIREMENTS
When making a Category 16 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). 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 1.1–1.4 of the Application Overview must all be completed.
2.2. Data
Data requirements for Category 16 applications are as follows:
| Description | Data Part | Equivalent module level |
|---|---|---|
| Application Overview | Part 1 | |
| Chemistry and Manufacture data for the active constituent | Part 2 | Module 2.1 or Module 2.2 |
Toxicology data for the active constituent, including drugs and poisons scheduling |
Part 3 |
Category 16 is a fixed category for which the fee and timeframe are predetermined. Although Category 16 is not a modular category, the chemistry and manufacture and toxicology data required correspond with modules described in Module levels for modular categories in Volume 3.
The toxicology data required for a Category 16 application correspond with those described for a Module 3.3 assessment in Module levels for modular categories. Detailed Part 2 and Part 3 data requirements can be determined by using in Module levels for modular categories in Volume 3.
Details of Part 2, and Part 3 data requirements can be seen by referring to Volume 3: Data requirements and guidelines.
The APVMA seeks advice from the Office of the Gene Technology Regulator (OGTR) on any application for approval of a genetically modified organism (GMO) or the product of a GMO. If the APVMA assesses an active constituent which is a GMO under Category 16, the applicant must address the OGTR’s requirements.
Imported biological agents require a permit from the Australian Quarantine and Inspection Service (AQIS) before they can be imported into Australia.
2.3. Fee and timeframe
The fee for a Category 16 application is $4,430.
The timeframe is eight months.
2.4. Data protection
Data protection applies for all applications which are assessed under Category 16 where the applicant is providing data to the APVMA that are eligible for protection. Publicly available data are ineligible for protection.
Applicants must provide a data list, including an entry for all information that meets the definition given on the APVMA website data protection page. This requirement applies irrespective of whether an application is eligible for data protection.
FOOTNOTES
- If an active constituent requires no toxicological assessment, it may be eligible for assessment under Category 17.
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
|