Category 17 application
Approval of a new active constituent:
Toxicology assessment not required

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 17 application as:

Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment.

A Category 17 application is for approval of a new active constituent where no assessment of toxicology data is required.

1.1.   Application types

The following are examples of new active constituents which may be eligible for assessment under Category 17:

• active constituents which are well known, in common use and have a history of safety in the context of use
  • some of these active constituents may have a standard in the European Pharmacopoeia, the British Pharmacopoeia (Veterinary), or the United States Pharmacopeia
    • - for example, glacial acetic acid, phosphorous acid and its salts, glucosamine hydrochloride, active constituents in herbal extracts, yeast extract hydrolysate and other naturally-derived, low toxicity active constituents (eg green-lipped mussel)
• food-quality ingredients of agricultural products (eg fruit drying oils)
• plant oils (eg canola, citronella, eucalyptus, orange, soybean)
• plant extracts (eg cabbage, garlic)
• natural substances isolated from flowers and other parts of plants (eg eugenol, geraniol, pyrethrum extract)
• active constituents included in the Therapeutic Goods Administration (TGA) list Substances that may be used as active ingredients in ‘listed’ medicines in Australia
• new sources of approved agricultural active constituents.

2.   REQUIREMENTS

When making a Category 17 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 17 applications are as follows:

Category 17 is a fixed category for which the fee and timeframe are predetermined. Although Category 17 is not a modular category, the chemistry and manufacture data required correspond with those described for a Module 2.2 assessment in Module levels for modular categories in Volume 3.

The data requirements for an application to approve a new source of an approved active constituent are equivalent to those for a Module 2.2 assessment.

Detailed Part 2 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 17, applicants must also address OGTR 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 17 application is $1,435.

The timeframe is five months.

2.4.   Data protection

Data protection applies for all applications which are assessed under Category 17 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 for chemistry data, including an entry for all information that meets the definition given on the APVMA website data protection page at http://www.apvma.gov.au/registration/data_protection.shtml. This requirement applies irrespective of whether an application is eligible for data protection.

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