This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/19761
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Product applications – applications made for the registration of pesticides (substances or mixtures of substance intended for preventing, destroying, repelling or mitigating any pest) and veterinary medicines (substances or mixtures of substances intended for treating diseases or conditions in animals). Product applications include applications within item numbers 1–14. It excludes notifiable variations and items 8L, 8P, 8M and 25.
Major assessments have assessment periods over three months and require one or more technical assessments. Includes item numbers 1, 2, 3, 4, 5, 6, 10, 11, 14 and 27.
Non-technical assessments have assessment periods of three months or less and have no technical assessment. Includes item numbers 7, 8, 9, 10A, 12, 13 and 13A.
Actives – the component of a pesticide or veterinary medicine product that is responsible for its physiological or pharmacological action. Applications for active constituents are covered under items 15–18, plus a number of applications in items 1, 2 and 27.
Permits – applications to use or possess an unregistered pesticide or veterinary medicine or for an off-label use of a registered pesticide or veterinary medicine. Covers items 19–23.
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.
Item 24 –?are technical assessments made under section 10 of the Code (other than those of the kinds described in any of items 1 to 10, 15, 16 or 17).
Item 25 – are technical assessments used to determine that a data package addresses the safety, efficacy and trade criteria. An outcome of a technical assessment can be used by an applicant as part of a future application.
Item 28 -?are technical assessments made under subclause 10(1) of Schedule 3AA to make or vary an ingredient determination.
Item 29 – applications for an Interchangeable Constituent Determination (ICD) that allows specified non-active constituents (excipients) to be substituted by other specified excipients without assessment. These determinations can apply to a single chemical product, a range of chemical products or a class of chemical products.
Notifiable variations – minor change to the details of a registered product, actives or labels 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, they are considered to be accepted upon lodgement by the applicant after some checks of the information.
Import consents – consents to import 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, eg for research, chemical trials or special veterinary applications in zoos. There is no statutory timeframe for the APVMA to process these but the APVMA aims to process import consents within 14 days.
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 these.