Category 22 application
Application for an emergency use permit

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 22 application as:

Application for a permit in respect of a chemical product or an active constituent if the proposed use of the chemical product or active constituent is determined by the APVMA to be an emergency use.

1.1.   Emergency use criteria

An emergency use is defined in the Agvet Code Regulations as:

…a use of the product or constituent arising from an emergency in which there is a genuinely believed need for the use of the product or constituent.

Emergency uses may involve either:

• the use of an existing registered veterinary product off-label; or
• the use of an unregistered veterinary product.

Emergency uses are situations where the proposed use is generally unforeseen (not seasonal, annual or on another regular basis), such as the outbreak of an exotic disease or the incursion of an endemic disease at a significantly higher rate or level than normal.

Applications for a Category 22 emergency use permit are most commonly received by the APVMA from the relevant government authority for control of emergency animal diseases. The APVMA encourages these authorities to submit applications for Category 21 minor use permits as a contingency, so that a proper evaluation of a veterinary product can be done in advance of possible disease outbreaks.

Situations which the APVMA will not generally accept as an emergency include (but are not limited to) the following:

• the situation has arisen because the applicant has not submitted a permit application in sufficient time to allow the APVMA to properly consider the application before the required treatment
• the disease has been allowed to proliferate contrary to sound veterinary practice to the stage where urgent control or treatment is required
• the disease generally recurs on a seasonal, annual or other regular basis
• resistance to registered products has built up and been evident over a period of time.

2.   REQUIREMENTS

When making a Category 22 application for an emergency permit, applicants must provide all of the following:

• one unbound copy of the combined Permit Application Form and Overview (refer to paragraph 2.1)
• if 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).

During a disease outbreak, the initial contact with the APVMA will often be by telephone. A written application should follow as soon as possible.

2.1.   Permit Application Form and Overview

The Permit Application Form and Application Overview have been combined into a single document (KP25F12) which is available on the APVMA website. 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 22 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 22 applications for emergency permits must satisfy the criteria of s.112 of the Agvet Code that the proposed use:

1. 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
2. would not be likely to have an effect that is harmful to human beings; and
3. would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment;
4. would not unduly prejudice trade or commerce between Australia and places outside Australia ; and
5. would be effective for the intended purpose.

Data requirements for Category 22 applications for emergency use permits are similar to those for Category 21 applications for minor use permits. The Category 21 chapter (Applications for a minor use permit) provides an outline of data requirements in the section titled Specific data requirements. These data requirements are similar for applications for emergency use permits.

All Category 22 applications require submission of data. The requirements 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

Note: Module 4 is for uses or products which may require poisons scheduling. Poisons scheduling will generally only be applicable to applications under Category 22 for emergency use of an unregistered product.

The APVMA recognises that in an emergency it may be necessary to accept reduced data. The APVMA will take into account things such as the limited duration and nature of the proposed emergency use and the qualifications and experience of persons undertaking the use.

2.2.1.  How to determine modules

Emergency use permit applications can involve:

• off-label use of an existing registered product;
• use of an unregistered product ie the product is NOT currently registered by the APVMA and NOT available for use in Australia.

The data Parts and modules that are likely to be required to support an application will vary considerably between applications, and between registered and unregistered products.

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

Applications for an emergency use permit are not subject to a fee, irrespective of the applicant.

No legislative timeframe applies to applications for emergency use permits, although the APVMA attempts to assess and finalise an application for an emergency use permit as soon as possible.

2.5.   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 at http://www.apvma.gov.au/qa/consent.shtml.

2.6.  Other requirements

The APVMA has always maintained a policy that an emergency use permit will not be issued if a suitably registered product is already available for that purpose. Therefore, applications for an emergency use permit where other products are already registered or available under permit for that purpose, must demonstrate that a genuine need exists for an alternative.

This may include demonstrating that the products currently registered or available under permit are ineffective or unsuitable for that use, or the proposed product offers advantages.

The APVMA does not consider cost or an applicant’s desire to use a product considered to pose a lower hazard as justification for the issue of an emergency use permit.

3.   GUIDELINES

3.1.   What constitutes a single application?

A single application under Category 22 for an emergency 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.

3.2.   Duration of permit

Emergency permits are time-limited. Therefore applicants should estimate the period over which they wish the permit to be issued. It may be difficult to estimate the length of time during which an emergency may exist, but in the first instance applicants should request no more than a 'reasonable' length of time, based on the nature of the emergency and the expected characteristics of the disease or pest.

3.3.   Extension of permit

Emergency permits will not be renewed without a fresh permit application. In its evaluation of a fresh application the APVMA will reconsider whether matters such as MRLs and use instructions which were set for the original emergency permit, are appropriate for a fresh emergency permit.

Revision history