Category 20 application
Application for a permit where a previous assessment remains valid and no data of a technical nature are required

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 suitable for consideration 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 and crop safety or environmental monitoring data.

Permit applications subject to confirmatory data requirements that will require further technical assessment DO NOT meet the purposes of Category 20, and must be assessed under Category 21 (minor use), Category 22 (emergency use) or Category 23 (research) as the case may be. They will be subject to the relevant modular assessment periods and fees that apply to these categories.

Additionally, permits issued by the States prior to the commencement of the Agvet Code on 15 March 1995 will not have been assessed by the APVMA and may also require application to be made under Category 21, 22 or 23.

2.   REQUIREMENTS

When making a Category 20 application, applicants must provide:

• a completed Permit Application Form (KP25F10) (available on the APVMA website)
• the relevant fee.

2.1.   Fee and timeframe

The fee for a Category 20 application is $320.

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 commercial state forestry operations and 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.   Minor amendments

Category 20 applications may include minor amendments, provided those amendments do not alter the previous risk assessment and thus require technical assessment.

Such minor amendments may include:

• variations in the persons to be covered by the permit (where those changes do not alter the ‘class’ or ‘classes’ of persons already covered)
• additional products to be covered by the permit, where the products are similar to the products already covered by the permit with respect to active constituent and corresponding rate/dose of application (ie active constituent per unit area) and where similarity between the products (ie formulation type) has already been demonstrated in a previous approval (registration or permit)
• small increases in the area or quantity of produce that may be treated, for example for research permits
• extensions to other States (where that extension does not require the submission of additional data).

Should the APVMA consider that a proposed permit amendment is not ‘minor’ and will therefore require a technical assessment an application under Category 21, 22 or 23 will be required, with supporting data to allow a technical assessment to be made. During screening, the APVMA will advise applicants of amendments not considered to be minor, and applicants considering amendments are encouraged to discuss these with the APVMA prior to application.

Examples of amendments NOT considered minor include:

• new products with different active constituents
• new products with the same active constituent but with significantly different formulation types that have not been demonstrated to be similar
• new crops or situations
• new target pests and diseases
• alterations to the rate, frequency or method of application
• new ‘classes’ of persons undertaking the use.

3.2.   Consolidating similar permits

An applicant may request that under a Category 20 application, the APVMA consider consolidating a number of previously-issued identical permits. This consolidation is particularly encouraged amongst regular minor use permit applicants/permit holders such as peak industry bodies. It will reduce the administrative and regulatory costs associated with maintaining a large number of individual minor use permits.

There are a number of factors that may affect consolidation. These include the nature of the product or active constituent, permit conditions, and other APVMA requirements with respect to minor use. Therefore permit holders should discuss proposals to consolidate a number of permits with the APVMA before applying.

3.3.   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.

Revision history