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Category 20 Application

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 20 application as:

Application for a permit where a previous assessment remains valid and no data of a technical nature is required.

The Agvet Code provides that the term of permits may be extended, but does not provide that permits may be renewed. However, an application may be made under Category 20 for a permit which is identical to an existing permit. If the permit application does not require further technical assessment, the APVMA may extend the duration of the existing permit.

Category 20 applications include applications to ‘renew’, ‘extend the duration of’ or ‘mirror’ an existing or previously issued permit for a minor use or research.

An application for a fresh emergency use permit which is identical to an existing emergency use permit or identical to a previously issued emergency use permit, must be made under Category 22 not Category 20.

1.1.   Permit extension

Minor use permits where the use of the product continues to:

• meet the requirements of a minor use as outlined in the Guidelines for determining minor uses; and
• be required because no (or limited) alternative products are approved and suitable for that purpose.

Research permits where the use continues to:

• meet the requirements of research as outlined in the Guidelines for determining emergency uses or research purposes; and
• be required as insufficient data and/or field evaluation are available to support registration and/or product development or product launch.

Permits issued under Category 19 to possess or supply unregistered chemical products for the purpose of export where there is ongoing export of unregistered chemical products.

Not all previously-issued permits are suitable for extension under Category 20. In issuing a permit the APVMA may have stated that continuation of that use under permit, after the initial permit period expires, is subject to conditions such as the applicant providing confirmatory data.

1.2.   Not all permits may be extended

Not all previously-issued permits will be eligible for application under Category 20.

In issuing a permit the APVMA may have stated that continuation of that use under permit after the initial permit period expires is subject to conditions such as the applicant providing confirmatory data. Such data may include (but not be limited to) residue, efficacy, target animal safety or environmental monitoring.

If the permit application:

• makes any change to a trial protocol; or
• requires a new animal ethics approval for a research permit; or
• requires the APVMA to assess compliance with the conditions of the existing permit; or
• is subject to confirmatory data requirements that will require further technical assessment

- it will not be eligible for an application under Category 20. In these cases the application will be assessed under either Category 21 (minor use) or Category 23 (research) as the case may be. The application will be subject to the relevant modular assessment periods and fees that apply to these application categories.

2.   REQUIREMENTS

When making a Category 20 application, applicants must provide:

• a completed Permit Application Form (KP25F10)
• the relevant fee.

2.1.   Fee and timeframe

The fee for a Category 20 application is $350.

The timeframe is three months.

2.1.1.   There is no permit application fee for Australian, State or Territory governments, in support of their core business

If the Australian, State or Territory governments apply for a permit in support of their core business, there is no fee.

Core business

Core business includes activities which are undertaken by officers of a government agency which are directly related to a control strategy being developed, implemented and communicated by that government agency. This includes activities relating to the management of exotic pests and diseases, or market access. There is no fee for permit applications relevant to such activities.

If a government officer applies for a permit on behalf of an industry group, and if that industry group would otherwise be required to pay a fee for the permit, the application made by the government officer is not fee exempt. Whilst certain departments and their officers provide advice on management of pests and diseases, the actual management of those pests and diseases is NOT core business of those agencies and it is rarely undertaken. Government officers may lodge such applications on behalf of primary industry groups, but payment of the appropriate fee is required.

Commercial benefit

Activities for which there is no fee for permit applications include those which attract a profit from investment and/or the service provided. This includes activities such as commercial research activities undertaken by departments/agencies. It encompasses development of new technologies either through contract research or in-house, and activities which produce intellectual property which may later be sold for profit, or are conducted on a fee-for-service basis.

2.2.   Data

Category 20 applications do not require the submission of data if a previous assessment remains valid.

Should additional data be required the APVMA will request the data during screening of the application and may request that an application be made under Category 21, 22 or 23 should those data require technical assessment.

3.   GUIDELINES

3.1.   Duration of an initial permit

When applying for a research permit, applicants are encouraged to request adequate time to allow the research to be completed, to avoid the need for a Category 20 application.

Minor use permits are issued with an expiry date, at which time the APVMA will review the conditions of the permit and/or data on which the conditions of the permit were based when it was issued.

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