Category 23 Application
1. DEFINITION
Schedule 6 of the Agvet Code Regulations describes a Category 23 application as:
Application for a permit in respect of a chemical product or an active constituent if the application is not of a kind described in items 19 to 21.
A Category 23 application is an application for a permit relating to a veterinary chemical product or active constituent, which is not a permit for export, minor use, emergency use, or renewal or extension of a previously-issued permit.
Permits issued under Category 23 are research permits or other (miscellaneous) permits.
Category 23 is a modular category. Data must be provided when a technical assessment is required. Data requirements, the fee payable and timeframe depend on which of the modules are required for assessment of a particular permit application. The modules are described in Module levels for modular categories in Volume 3 and also in the guidelines and examples later in this chapter.
1.1. Research permit criteria
Research uses may involve either:
- the unapproved (‘off-label’) use of an existing registered veterinary chemical product; or
- the use of an unregistered veterinary chemical product.
For the purposes of an application for a research permit under Category 23, the APVMA defines research to be technical work of an investigative nature which occurs during development of new veterinary chemicals. It includes scientific research or investigation relevant to generating data required by the APVMA for registration or approval and includes:
- screening of potential new active constituents or products
- generating data required by the APVMA for registration or approval
- testing a particular set of label instructions, new packaging or application technology
- undertaking a scientific study where the use of an active constituent or product is crucial to the conduct of the experiment
-
other work determined by the APVMA to be genuine research.
Situations that will generally not be considered to be research include:
- market testing
- supply and use of an unregistered product in order to gain early market access.
Application to the APVMA for a permit to conduct small-scale trials is not required provided that the research use complies with all of the conditions of small-scale trial permit 7250 (including the requirement that no produce resulting from the trial will be made available for human consumption). Permit 7250 may be viewed at http://permits.apvma.gov.au/PER7250.PDF.
1.2. Other (miscellaneous) permits
Category 23 includes an application for a permit that would overcome the offences under sections 74, 75, 76, 77, 78, 79, 79A, 79B, 80, 81, 84, 85, 87, 87A, or 91 of the Agvet Code. These sections relate to the possession and supply of active constituents, chemical substances and chemical products, and offences relating to labels and claims.
The most common other (miscellaneous) permit applications under Category 23 include:
- extension of the shelf life for a particular batch or batches of a registered product
- supply of a particular batch or batches of a registered product where the batch does not comply with product specifications
- overstickering of information on the approved label of a registered product.
2. REQUIREMENTS FOR A RESEARCH PERMIT
When making a Category 23 application for a research permit, applicants must provide all of the following:
- one unbound copy of the combined Application Form and Overview (refer to paragraph 2.1)
- details of the design of the research trial (trial protocol - refer to paragraph 2.2)
- one bound copy of each of the relevant data Parts (refer to paragraph 2.4)
- a draft label if relevant (refer to paragraph 2.5)
- the relevant fee (refer to paragraph 2.6).
2.1. Combined Permit Application Form and Overview
The Permit Application Form and Application Overview have been combined into a single document. A single unbound copy of the combined document must be provided to the APVMA.
The Application Form is required information and must be completed.
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.
- Application for a Research Permit for an Veterinary Chemical Product - KP25F27
- Application for a Permit for Supply a Batch of Product / Label Oversticker - KP25F14
2.2. Trial protocol
Applicants must provide the trial protocol (trial design) to the APVMA before the APVMA will issue a Category 23 research permit. The trial protocol is required to assist the APVMA decide whether it should grant the permit application.
The trial protocol will vary depending on the type of veterinary chemical product being studied and the objectives of the trial, but should include:
- Title of the trial, expected dates of commencement and completion of the trial, personnel involved and details of the locations where the trial will be conducted.
- The objectives of the trial.
- Numbers of animals involved. Information on selection of animals including the number, age, species, breed, sex, physiological condition (such as pregnancy or lactation) and inclusion/exclusion criteria.
- Brief description of animal husbandry arrangements.
- A broad overview of the trial design, and statistical validity.
- Treatment regime with details of the formulation used (including batch numbers), dose rate, method, route, frequency and duration of admin istration of treatment and acclimatisation period.
- Measurement parameters.
An applicant may request a critical evaluation the APVMA’s assessment of the trial protocol by applying under Category 25.
2.3 Animal Ethics Committee approval
At the time of application to the APVMA the applicant must first have submitted a protocol for assessment by an approved animal ethics committee, and must currently be registered or licensed as an animal investigator in the relevant State jurisdictions.
If the applicant has not yet received the approval for the trial from the relevant animal ethics committee, the applicant must state in the application when this is expected and the approval must be submitted to the APVMA prior to commencement of the trial.
2.4. Data
Category 23 applications for research permits must satisfy the criteria of section 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.
All Category 23 applications for a research permit 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 following data Parts may be required. The 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: Module 4 is for uses or products which may require poisons scheduling. Poisons scheduling will generally only be applicable to Category 23 applications for unrestricted use of an unapproved active constituent.
2.4.1. How to determine modules
The data modules required to support an application 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).
2.4.2. Data requirements for registered products compared to unregistered products
The proposed use of a registered product under a research permit will not require the submission of as much data as would generally be required to support the use of an unregistered product or a registered product for a new major use. The level and type of data that are required to support the use of a registered product under a research permit are largely determined by the extent of the proposed use and how similar or dissimilar the proposed use is in relation to the registered product’s current approved uses.
Applications for research permits involving a registered product do not usually require the submission of data with respect to chemistry and manufacture (Part 2), toxicology (Part 3), metabolism and kinetics (Part 4), or target species efficacy and safety (Part 8) as this data will have already been provided to the APVMA for registration of the product.
Furthermore, should the proposed research be similar to existing approved uses for that product in terms of use regime (ie dose/application rate, frequency, route of admin istration and disposal), there is usually no requirement to submit data with respect to occupational health and safety (Part 6) and environment (Part 7) because data for these criteria will normally have already been assessed by the APVMA for other similar use patterns.
Applications for research permits involving unregistered products will require the submission of significantly more data and be subject to greater assessment than applications for registered products, because regulatory standards and assessments for unregistered products are likely to be either non-existent or limited.
Unregistered veterinary products in most cases will require formulation according to GMP or equivalent standard.
2.5. Label
2.5.1. Registered products
For registered products where the research to be conducted is off-label, a leaflet may be produced which contains only information relevant to the off-label use and information required to comply with the requirements of the research permit. This may be limited to the name of the product, an active constituent statement, a directions for use table and any additional instructions pertinent to that use.
Leaflets must also contain the following statement in a prominent position:
FOR RESEARCH USE ONLY THIS USE PATTERN IS NOT REGISTERED |
2.5.2. Unregistered products
For unregistered products, applicants must provide a draft product label that will be attached to the container. This label must be in a format that is consistent with the Vet Labelling Code (see Volume 5: Labelling), as if the product were to be supplied as a registered product.
The label and leaflet must also include the following statement in a prominent position on the main panel of the label:
FOR RESEARCH USE ONLY THIS PRODUCT IS NOT REGISTERED |
If unregistered products are to be used solely by company personnel employed by the permit holder, the APVMA may allow reduced labelling directions if the applicant will provide other material to staff undertaking the use, such as leaflets or a copy of the permit itself.
Full labelling of an unregistered product is required if the applicant will supply the product to collaborators who are not employed by the permit holder, including farmers.
2.6. Fee and timeframe
Category 23 is a modular category, therefore the fee payable and timeframe depend on which of the modules are required for assessment of the application.
The fee for a Category 23 permit application will always include the fees for Module 1 (Screening), plus the relevant Finalisation module (11.1, 11.2, or 11.4).
A fee must accompany a Category 23 application. Applicants may provide the complete fee when submitting the application, or may choose to provide $505 (Screening module fee) when submitting the application and provide the remainder of the fee when requested by the APVMA, after the application passes screening.
To calculate the timeframe assigned to an application, the longest assessment period for the specific data modules should be added to the timeframe for the relevant finalisation module.
The fee and timeframe for each application may be calculated by reference to Module levels for modular categories in Volume 3.
2.6.1. 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.
2.7. Consent to import an unapproved active constituent or unregistered chemical product
Active constituents and/or products which are not approved or registered and which will be imported into Australia for manufacture into products for export or for which Australia may be used as a distribution point, 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.
3. GUIDELINES FOR a RESEARCH PERMIT
3.1. What constitutes a single application?
An application is necessary when a scientist seeks to investigate the unapproved use of a veterinary product to treat an animal disease, infestation or condition according to a scientific protocol which reflects the ability of the applicant to conduct such research using principles of Good Veterinary Clinical Practice and Good Laboratory Practice. Applications must demonstrate that the proposed investigations satisfy regulatory provisions regarding animal experimentation in the jurisdictions in which the research is conducted.
For the purposes of Category 23 research permit applications, one application may involve one or more veterinary products only when their formulations and uses are described in a single trial protocol.
The APVMA will not generally accept single applications for multiple trial protocols, unless these are replicates of each other for a single animal disease, infestation or condition.
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.
3.2. Examples
Example 1: Application is made for a research permit to conduct trials on cattle on farms in NSW and Queensland in order to determine the efficacy and residue aspects of an unregistered ectoparasiticide pour-on product which contains a new active constituent. Produce from trial animals treated with the unregistered product will be made available for human consumption. The product is currently registered in the USA.
The Australian efficacy and residue data will be used to support a future application to the APVMA to register the product. Chemistry and manufacture and some overseas efficacy and animal safety data will be required in order for the APVMA to be satisfied of product quality, efficacy and animal safety, but modular assessments of these data will not normally be undertaken. Chemistry and manufacture data are required as part of the toxicological data package.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
| Chemistry and Manufacture | Part 2 |
| Toxicology | Part 3 |
| Metabolism and Kinetics | Part 4 |
| Residues and Trade | Part 5 |
| Occupational Health and Safety | Part 6 |
| Environment | Part 7 |
| Efficacy and Safety | Part 8 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 3.1 | Toxicology – Level 1 | $19,490 |
| Module 5.1 | Residues – Level 1 | $5,595 |
| Module 6.2 | OHS – Level 2 | $2,900 |
| Module 7.2 | Environment – Level 2 | $3,255 |
| Module 11.1 | Finalisation – Type 1 | $2,230 |
Total fee: |
$30,885 |
|
Timeframe: |
15 months |
Example 2: Application is made for a research permit to conduct trials on sheep on farms in NSW and Victoria in order to determine the efficacy aspects of an unregistered anthelmintic product which contains a new active constituent. The product is in the form of a slow-release intraruminal capsule which is administered orally. Produce from trial animals treated with the unregistered product will be made available for human consumption. The product is currently registered in several European countries and the applicant has provided an OECD-quality comprehensive toxicological assessment report on the active constituent by the European Medicines Agency (EMEA).
The Australian efficacy and residue data will be used to support a future application to the APVMA to register the product. Chemistry and manufacture and some overseas efficacy and animal safety data will be required in order for the APVMA to be satisfied of product quality, efficacy and animal safety, but modular assessments of these data will not normally be undertaken. Chemistry and manufacture data are required as part of the toxicological data package. Occupational health & safety assessment is not required for this permit application because of the nature of the dose form and the fact that it is to be used in the trial by trained personnel only.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
| Chemistry and Manufacture | Part 2 |
| Toxicology | Part 3 |
| Metabolism and Kinetics | Part 4 |
| Residues and Trade | Part 5 |
| Environment | Part 7 |
| Efficacy and Safety | Part 8 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 3.3 | Toxicology – Level 3 | $2,900 |
| Module 5.1 | Residues – Level 1 | $5,595 |
| Module 7.2 | Environment – Level 2 | $3,255 |
| Module 11.1 | Finalisation – Type 1 | $2,230 |
Total fee: |
$13,165 |
|
Timeframe: |
15 months |
Example 3: Application is made for a research permit to conduct trials in pigs using a registered injectable product containing an approved antibiotic active constituent. Use of the antibiotic active constituent has previously been approved only in cattle and sheep. Produce from trial animals treated with the product will be made available for human consumption. The resulting residue, efficacy and animal safety data will be used to support a future application to the APVMA to approve this variation to the use pattern of the product. A special data assessment is required in order to address potentially increased risks to humans of transfer of antibiotic resistance associated with use of the antibiotic in the new animal species.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
| Residues and Trade | Part 5 |
| Environment | Part 7 |
| Special Data (antibiotic resistance) | Part 10 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 5.3 | Residues – Level 3 | $2,490 |
| Module 7.3 | Environment – Level 3 | $620 |
| Module 10.2 | Special Data (antibiotic resistance) – Level 2 | $0 |
| Module 11.1 | Finalisation – Type 1 | $2,230 |
Total fee: |
$5,315 |
|
Timeframe: |
9 months |
Example 4: Application is made for a research permit to conduct trials in sheep using a registered anthelmintic drench product at an increased dose compared with the approved dose rate in order to determine efficacy against resistant intestinal parasites and to test animal safety. Produce from trial animals treated with the product used at the unapproved dose rate will be made available for human consumption. The efficacy and safety data will be used to support a future application to the APVMA to approve this variation to the use pattern of the product. The increased dose rate of the drench product is not considered to pose significantly increased risks in terms of occupational health & safety.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
| Residues and Trade | Part 5 |
| Environment | Part 7 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 5.5 | Residues – Level 5 | $1,175 |
| Module 7.3 | Environment – Level 3 | $620 |
| Module 11.3 | Finalisation – Type 3 | $620 |
Total fee: |
$2,660 |
|
Timeframe: |
6 months |
4. OTHER (MISCELLANEOUS) PERMITS
Category 23 includes an application for a permit that would overcome the offences under sections 74, 75, 76, 77, 78, 79, 79A, 79B, 80, 81, 84, 85, 87, 87A, or 91 of the Agvet Code. These sections relate to the possession and supply of active constituents, chemical substances and chemical products, and offences relating to labels and claims.
The most common other (miscellaneous) permit applications under Category 23 include:
- extension of the shelf life for a particular batch or batches of a registered product
- supply of a particular batch or batches of a registered product where the batch does not comply with product specifications
- overstickering of information on the approved label of a registered product.
4.1. Permits relating to a particular batch of product
Application may be made under Category 23 for a miscellaneous permit relating to a particular batch or batches of a registered product, such as extensions of shelf life, supply where the batch does not comply with product specifications, and overstickering of information on the approved label.
4.1.1. Permit to extend the shelf life of a particular batch of product
Applicants should refer to the specific guideline on the APVMA website on requirements for the application/assessment/approval of extension of shelf life for a particular batch of a registered veterinary chemical product.
When making an application under Category 23 for a permit to extend the shelf life of a particular batch or batches of a registered product, applicants must provide:
- one unbound copy of the combined Application Form and Overview
The Application Overview must include:- the purpose of the application and supportive argument to justify the extension of shelf life
- a list of all relevant batches, original and proposed expiry dates, storage locations (eg warehouses) and storage conditions
- batch release and expiry specifications of the registered product
- a copy of the proposed label oversticker text
- one bound copy of Part 2 (if applicable):
- stability data, results of analytical testing and validation data must be provided in the chemistry (Part 2) submission
- a chemistry (Part 2) data package may not be required for certain applications – for example, where the APVMA has recently approved an extension of shelf life of a registered product and the applicant wishes to oversticker the labels of an existing batch of the product with an amended expiry date to reflect the new approved shelf life
- the relevant fee (refer to paragraph 2.5).
Example 1: Application is made to extend the shelf life of three batches of a chemical product for 12 months longer than the currently approved 36 month shelf life of the registered product. The submission includes supporting stability data for the particular batches of product.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
| Chemistry and Manufacture | Part 2 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 2.4 | Chemistry – Level 4 | $200 |
| Module 11.4 | Finalisation – Type 4 | $160 |
Total fee: |
$785 |
|
Timeframe: |
5 months |
Example 2: Application is made to extend the shelf life of one batch of a chemical product. The APVMA has recently approved a 12-month extension of shelf life for the registered product and the applicant wishes to oversticker the labels of one existing batch of the product with an amended expiry date to reflect the new approved shelf life. The applicant has provided scientific argument, including warehouse storage location and conditions for the particular batch, to justify the application.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 11.4 | Finalisation – Type 4 | $160 |
Total fee: |
$605 |
|
Timeframe: |
2 months |
Note: The APVMA will endeavour to process all permit applications to extend the shelf life of a particular batch of product well within the legislated timeframe.
4.1.2. Permit to supply a particular batch of product where the batch does not comply with product specifications
When making an application under Category 23 for a permit to supply a particular batch or batches of a registered veterinary chemical product where the batch does not comply with product specifications, applicants must provide:
- one unbound copy of the combined Application Form and Overview
- one bound copy of each of the relevant data Parts
- assessment of data may be required, depending on the nature of the non-compliance with a product specification. If there are implications for stability of the batch then stability data, analytical testing and validation data will be required in a chemistry (Part 2) data package. Other data Parts may be required if there are implications for other risk areas such as efficacy and animal safety (Part 8) or residues (Part 5)
- the relevant fee (refer to paragraph 2.5).
Example 1: Application is made for a permit to supply a particular batch of a live vaccine product for use in cats because the batch exceeds the approved maximum release titre. The submission includes supporting animal safety data for the particular batch of vaccine.
Data requirements are expected to be drawn from:
| Application Overview | Part 1 |
| Efficacy and Safety | Part 8 |
The following modules are expected to apply:
| Module | Description | Fee |
|---|---|---|
| Module 1 | Screening | $505 |
| Module 8.3 | Efficacy & Safety – Level 3 | $500 |
| Module 11.3 | Finalisation – Type 3 | $620 |
Total fee: |
$1,480 |
|
Timeframe: |
5 months |
4.1.3. Other permits relating to a particular batch of product
All other permits relating to a particular batch of a registered product will be assessed on their merits. The relevant modules will apply if assessment is required of associated data. If no technical assessment is required, or if the application can be assessed at screening, then only screening (Module 1) and finalisation (Module 11.4) modules will apply.
4.2. Miscellaneous permits
Applications for a permit under Category 23 may include compliance permits relating to the possession and supply of active constituents, chemical substances and chemical products, and other situations relating to labels and claims where an offence would be committed against the Agvet Code unless the APVMA has issued a permit. The relevant modules will apply if assessment of associated data is required. If no technical assessment is required, or if the application can be assessed at screening, only screening (Module 1) and finalisation (Module 11.4) modules will apply.
When making an application under Category 23 for a permit of this nature, applicants must provide:
- a covering letter that includes the purpose and justification for the permit application
- one bound copy of each of the relevant data Parts (refer to paragraph 2.3)
- the relevant fee (refer to paragraph 2.5).
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
|