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.   Category 16 applications are rarely used for approval of active constituents used in veterinary medicines

Category 16 applications are rarely used for approval of active constituents used in veterinary medicines because assessment and approval of new active constituents in veterinary medicines is done as a part of the product registration under Category 2.

For further information, refer to Category 2.

1.2.   Application types

If an applicant wishes to have an active constituent approved under Category 16, the following are examples of new active constituents which may be eligible for assessment under Category 16¹:

• an active constituent for which an acceptable comprehensive toxicological assessment report has been provided. 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 (KP21F21) which is available on the APVMA website. A single unbound copy of the combined document must be provided to the APVMA.

The Application Form requires information which is relevant to a Category 16 application.

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 Volume 3, Part 1.

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:

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 Volume 3, ‘Module levels for modular categories’.

The toxicology data required for a Category 16 application correspond with those described for a Module 3.3 assessment in Volume 3, ‘Module levels for modular categories’. Detailed Part 2 and Part 3 data requirements can be determined by using 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 a GMO is assessed under Category 16, OGTR requirements must also be addressed.

Imported biological agents require a permit from the Australian Quarantine and Inspection Service (AQIS) before they can be brought into Australia.

2.3.   Fee and timeframe

The fee for a Category 16 application is $4,025.

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 in the Data Protection documentation on the APVMA website at http://www.apvma.gov.au/registration/data_protection.shtml. This requirement applies irrespective of whether an application is eligible for data protection.

Footnotes

1. If an active constituent requires no toxicological assessment, it may be eligible for assessment under Category 17.

Revision history