Limitation periods

The limitation on use of information provisions do not apply to information if it is:

  • information to which a limitation period applies and the limitation period has ended, or
  • information to which a limitation period applies and the information is to be used to reconsider an approval or registration if the decision on the reconsideration is made after the limitation period has ended.

The limitation on use of information provisions apply only for the duration of the relevant limitation period.

The table below sets out the limitation periods for certain information given in connection with an application made under section 10 or 27 of the Agvet Code. If the information is provided to the APVMA in connection with such an application, and the application is not granted (for example, it is refused by the APVMA or withdrawn by the applicant), that information does not have a limitation period and it remains subject to the limitation on use of information provisions (that is, it’s use is limited indefinitely).

Item Circumstance in which information is given Limitation period
1 Given in connection with an application under section 10 for approval of an active constituent (for a proposed or existing chemical product) that was not a previously endorsed active constituent and was relied on for approval of the active constituent 10 years after the active constituent is approved
2 Given in connection with an application under section 10 for registration of a chemical product, at least one of whose active constituents was not a previously endorsed active constituent when the application passed preliminary assessment, or approval of a label for a container for a chemical product, at least one of whose active constituents was not a previously endorsed active constituent when the application passed preliminary assessment, and was relied on to register the product or approve the label 10 years after the product is registered and the label approved
3 Given in connection with an application (except one covered by item 2) made under section 10 for registration of an agricultural chemical product or approval of a label for a container for an agricultural chemical product, and was relied on to register the product or approve the label 5 years after the product is registered and the label approved
4 Given in connection with an application (except one covered by item 2) made under section 10 for registration of a veterinary chemical product or approval of a label for a container for an agricultural chemical product and was relied on to register the product or approve the label 3 years after the product is registered and the label approved
5 Given in connection with an application made under section 27 for variation of the relevant particulars or conditions of the registration of an agricultural chemical product or approval of a label for a container for an agricultural chemical product and was relied on to vary the relevant particulars or conditions 5 years after the product is varied and the label approved
6 Given in connection with an application made under section 27 for variation of the relevant particulars or conditions of the registration of a veterinary chemical product or approval of a label for a container for an veterinary chemical product, and was relied on to vary the relevant particulars or conditions 3 years after the product is varied and the label approved

The table below sets out the limitation periods for information given to the APVMA under section 161 of the Agvet Code

Item Circumstance in which information is given Limitation period
1 Given under section 161 in connection with an agricultural chemical product 5 years after the information is given
2 Given under section 161 in connection with a veterinary chemical product 3 years after the information is given

 

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