Glossary of terms

8L, 8M and 8P

Applications to either change the holder or nominated agent of an approval or registration or nominate a nominated agent for an approval or registration.

Actives

The component(s) of a pesticide or veterinary medicine product that is primarily responsible for its action. Applications for active constituents are covered under Item numbers 1, 2, 15, 16, 17, 18. Actives can also be included in applications under Item numbers 5, 6, 10, 14, 24, 27 and 27V.

Certificates of export

Before accepting exports of a chemical product from Australia, many countries require an assurance from the government authority responsible for regulating the product in Australia. This is provided by the APVMA in the form of a certificate of export. There are no statutory timeframes for the APVMA to process an application for a certificate of export.

Emergency permits

Application for a permit, or extension of 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. Emergency permits applications are made under Item number 22.

Import consents

Import consents are permits that allow unregistered or unapproved chemicals into Australia when a legitimate reason exists for a person or company to have possession of the chemicals in Australia. Legitimate reasons include possession for research, chemical trials or special veterinary applications in zoos. There is no statutory timeframe for the APVMA to process import consents, but the APVMA aims to process them within 14 days of lodgement.

Item 25

Applications made under s 8AS of the Agricultural and Veterinary Chemicals Code Regulations 1995. These are technical assessments used to determine if a data package addresses the safety, efficacy and trade criteria prior to submitting a product application. An outcome of a technical assessment can be used by an applicant as part of a future application.

Item numbers

Item numbers are defined in Table 2.1 of Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995. They are used to determine the assessment periods and fees for different kinds of applications.

Major assessments

Applications that have assessment periods of more than 3 months and that require one or more technical assessments. These include Item numbers 1, 2, 3, 4, 5, 6, 10, 11, 14, 27 and 27V.

Non-technical assessments

Applications that have assessment periods of 3 months or less and that do not require a technical assessment. These include Item numbers 7, 8, 9, 10A, 12, 13 and 13A.

Notifiable variations

A minor change, as defined by Agricultural and Veterinary Chemicals Code Regulations 1995, to the details of a registered product, active or label without having to register a new product. This process commenced on 1 January 2015. There is no statutory timeframe for the APVMA to process these as they are deemed to be accepted upon lodgement by the applicant after some checks of the information.

Processed

Includes all applications that the APVMA completed processing during the reporting period. This includes applications for which a regulatory decision was made as well as applications that were withdrawn by the applicant or voided having been lodged in error.

Product applications

Applications made for the registration of products that are pesticides or veterinary medicines. Product applications include applications under Item numbers 1 to 14, including 10A and 13A, as well as Item numbers 24, 27 and 27V.

Received

Includes all applications that were received by the APVMA during the reporting period.

Permits (excluding emergency)

Applications to use or possess an unregistered pesticide or veterinary medicine or for an off-label use of a registered pesticide or veterinary medicine. Permit applications include applications under Item numbers 19, 20, 21, 23 and can also be made under s 112A of the Agricultural and Veterinary Chemicals Code Act 1994.