Category 21 Application
1. DEFINITION
Schedule 6 of the Agvet Code Regulations describes a Category 21 application as:
Application for a permit where the proposed use is a minor use.
Applications under Category 21 for a minor use permit can include one of the following:
- the ‘off-label’ use of an existing registered veterinary product
- the use of an unregistered veterinary product
- use of an autogenous vaccine.
1.1. Minor use criteria
A minor use as defined in the Agvet Code as:
…a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
All applications for a minor use permit must satisfy one of the following criteria:
- the permit is for a minor food-producing species (not cattle, sheep, pigs, chickens); or
- if the permit is for a major food-producing species, use of the product must be limited to the following:
Cattle: up to 5,0001 doses per year
Sheep: up to 20,0001 doses per year
Pigs: up to 10,0001 doses per year
Chickens: up to 100,0001 doses per year - if neither of the above apply, the applicant must provide evidence that economic return would not be sufficient to meet the cost of registration of the veterinary product.
1.2. Veterinary surgeons’ prescribing rights
Under state Veterinary Surgeons Acts, registered veterinary surgeons may prescribe unregistered veterinary medical treatments for animals in their care. These prescribing rights provide animal owners with access to minor use treatments when required.
Permits for minor use are only required where states have limited such prescribing rights, for instance to companion animals or to individual animals of a food-producing species. Where states have limited such prescribing rights, the APVMA will, in consultation with those states, consider granting a minor use permit for the treatment of a larger number of animals for a specified purpose.
2. REQUIREMENTS
When making a Category 21 application for a minor use permit, applicants must provide all of the following:
- one unbound copy of the combined Permit Application Form and Overview (refer to paragraph 2.1)
- where data are provided with the application, one bound copy of each of the relevant data Parts (refer to paragraph 2.2)
- a draft label if relevant (refer to paragraph 2.3)
- the relevant fee (refer to paragraph 2.4).
2.1. Combined Permit Application Form and Overview
The Permit Application Form and Application Overview have been combined into a single document (KP25F11). 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 21 permit 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 Part 1 – Application overview in Volume 3.
2.2. Data
Category 21 applications for minor use permits must satisfy the criteria of s.112 of the Agvet Code, that the proposed use:
- would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
- would not be likely to have an effect that is harmful to human beings; and
- would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
- would not unduly prejudice trade or commerce between Australia and places outside Australia; and
- would be effective for the intended purpose.
Category 21 is a modular category, therefore data studies and timeframes are determined by the module levels required for permit assessment, which themselves are determined by the type of product and the situations in which the product will be used.
All Category 21 applications require submission of data. The data modules are directly relevant to the level of assessment required and are determined by:
- the product and its active constituent
- the proposed use
- the presence and relevance of existing regulatory standards already established for that product or active constituent in Australia
-
the similarity of the proposed use to currently approved uses of the product/active constituent in Australia.
Any combination of the data Parts and modules in Table 1 may be required. The data Parts refer to Volume 3: Data requirements and guidelines.
Table 1. Data Parts and corresponding modules
| Data Parts | Modules | |
|---|---|---|
| Part 2 | Chemistry and Manufacture | 2.2 or 2.4 |
| Part 3 | Toxicology | 3.1 – 3.3 ± 4 |
| Part 4 | Metabolism and Kinetics | |
| Part 5 | Residues and Trade | 5.1 or 5.3 or 5.5 |
| Part 6 | Occupational Health and Safety (OHS) | 6.2 or 6.3 |
| Part 7 | Environmental Safety | 7.2 – 7.3 |
| Part 8 | Efficacy and Host Animal Safety | 8.3 |
| Part 9 | Non-food Trade | 9 |
| Part 10 | Special Data | 10.1 – 10.3 |
Note: Modular item 4 exists for uses or products which may require poisons scheduling. Poisons scheduling will generally only apply to Category 21 applications for an unrestricted use of an unapproved active constituent. Note that the Application Overview (Part 1) is always required.
2.2.1. How to determine modules
The data modules will depend on the product, its active constituent, the proposed use, and the presence and relevance in Australia of existing regulatory standards already established for that product or active constituent.
Details and guidance on data Parts and modules are provided in Volume 3: Data requirements and guidelines.
Applicants should note that applications for a minor use permit are always subject to two non-technical modules: Screening (Module 1) and Finalisation (Module 11.1, 11.3 or 11.4).
Applications which require three or more modular assessments (for example Residues, OHS and Environment) will be subject to Module 11.1 (timeframe three months). Applications that require one or two modules (for example Residues and Efficacy/Host Safety) will be subject to Module 11.3 (timeframe two months). Applications which require only a minor chemistry assessment will be subject to Module 11.4 (timeframe two months).
2.3. Label
For unregistered products, a copy of all parts of the label that will be attached to the container must be provided with the application.
As part of its assessment, the APVMA will consider the appropriate labelling for use of the unregistered product under permit. Generally, the label must conform to the Vet Labelling Code.
2.4. Fee and timeframe
The fee for a Category 21 application is $350.
Category 21 is a modular category, therefore the timeframe depends on which of the modules are required for assessment of the application.
To calculate the timeframe assigned to an application once it has passed screening, an applicant must add the longest assessment period for a specific data module to the relevant finalisation module (11.1, 11.3 or 11.4).
2.4.1. 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.
2.5. Other requirements
The APVMA has always maintained a policy that it will not issue a minor use permit if a suitable registered product is already available for the purpose requested in the permit application. Therefore, applications that seek a minor use permit where other products are already registered or permitted for that purpose must demonstrate that a genuine need exists for an alternative.
The APVMA does not consider cost, or an applicant’s desire to use another product, to be sufficient reason for the issue of a minor use permit.
3. GUIDELINES
3.1. What constitutes a single application?
Applications under Category 21 for a minor use permit may only involve one of the following:
- one or more veterinary products containing either a single active constituent or in the case of polypharmacy, a single specific combination of active constituents; or
-
two or more veterinary products each containing different single active constituents or specific combinations of active constituents where those products depend directly on one another (ie either used in combination or in succession) to achieve the required level of efficacy against the target pest/disease or condition; or
-
a biological veterinary medicine with an active constituent or constituents which are unique to and derived from an individual, defined group or geographical area, for autologous treatment after in vitro formulation.
The APVMA will not generally accept a single application for multiple products involving different active constituents, unless those products depend directly on one another as described above. This is because different active constituents will be subject to different data requirements and assessments and individual applications must be submitted and assessed by the APVMA.
However, one application may involve multiple hosts, pests/diseases/conditions and patterns of use.
3.2. Different types of veterinary medicines
Veterinary medicines may be Schedule 4 Prescription Animal Remedy and Schedule 8 Controlled Drugs which are prescribed by registered veterinarians, or products which do not require a prescription (either unscheduled medicines or scheduled in other than S4 or S8, or products which have never been scheduled), or any of the above in combination.
Prescription Animal Remedies (S4) can only be used by, or under supervision or direction of, a registered veterinarian. Controlled Drugs (S8) can only be used by registered veterinarians and are subject to additional conditions of storage and use.
State prescribing laws allow the use by veterinarians of unregistered products or off-label use of registered products. This applies to both prescription and non-prescription products. Permits are only required where States have placed limitations on such prescribing rights.
Animal owners should always consult their veterinarian about products already available for off-label (minor) use through veterinary prescription. If no suitable products are available, the veterinarian or owner can make an application under Category 21 for a minor use permit. However, if the product contains a Schedule 4 Prescription Animal Remedy or Schedule 8 Controlled Drug, the prescribing veterinarian must make the application on behalf of the animal owner.
Manufacturers and/or suppliers who wish to supply veterinarians with prescription products that they can legally use under state law can apply for a minor use permit for ‘supply to veterinarian only’.
4. SPECIFIC DATA REQUIREMENTS
4.1. Registered products
4.1.1. Definition of a registered product
A registered product is one which is currently registered by the APVMA, has an approved product label and is available for use in Australia.
4.1.2. Determining data requirements
Data modules will vary depending upon the nature of the proposed use, how similar or dissimilar the proposed use is to currently approved use patterns, and the relevance of existing regulatory standards. This allows certain data Parts to be exempted (refer to further details under paragraph 4.1.3 below).
The proposed use of a registered product under a minor use permit will not require the submission of the same level of data as would be required to support the use of an unregistered product, or a new major use for a registered product.
The level and type of data that are required to support the use of a registered product under a minor use permit are largely determined by the extent of the proposed use and how similar or dissimilar the proposed use is to the registered product’s current approved uses.
4.1.3. Data exemptions
Applications for minor use permits involving a registered product do not usually require the submission of data with respect to Chemistry and Manufacture (Part 2), Toxicology (Part 3) or Metabolism and Kinetics (Part 4) as these data will have already been provided to the APVMA for registration of the product.
Furthermore, should the proposed minor use be similar to existing registered uses for that product in terms of use regime (ie dose/application rate, frequency, method and environment) data on Occupational Health and Safety (Part 6) and Environment (Part 7) are not usually required because these data will normally have already been assessed by the APVMA for the existing approved use.
4.2. Unregistered products
4.2.1. Definition of an unregistered product
An unregistered product is a product which is NOT currently registered by the APVMA and is NOT available for use in Australia.
There are two types of unregistered veterinary chemical products:
- Unregistered products which contain an active constituent which has not undergone previous assessment in Australia
These include active constituents that do not have any regulatory standards established in Australia, are not approved active constituents, have not been previously assessed by the APVMA and/or are not present in an existing registered product in Australia. - Unregistered products which contain an active constituent which has undergone previous assessment in Australia
These include active constituents likely to have some regulatory standards established in Australia. They may include an approved active constituent or an active constituent that has previously been assessed by the APVMA and/or may be present in an existing registered product in Australia.
4.2.2. Determining data requirements
Applications for minor use permits for unregistered products will require the submission of significantly more data and be subject to greater assessment than minor use permit applications for registered products, because regulatory standards and assessments for unregistered products are likely to be either non-existent or limited.
Unregistered veterinary chemicals will generally require formulation according to good manufacturing practice (GMP) or equivalent standard, except for chemicals formulated by a prescribing veterinarian or a pharmacist on the prescription of a registered veterinarian as described under s.5(4) of the Agvet Code.
4.2.3. Import of unregistered products
Products and/or active constituents which are not registered or approved, and which will be imported into Australia, require a Consent to import unapproved active constituents or unregistered agricultural or veterinary chemical products.
Details on obtaining a consent may be found on the APVMA website.
FOOTNOTES
- This information in MORAG now supersedes the information given in the Notice: Guidelines for Determining Minor Uses published in the APVMA Gazette in March 2002.
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
|