Limits on use and disclosure of information

The APVMA can use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under the Agvet Code and the Agvet Code Regulations, subject to certain limitation on use and confidential commercial information provisions and contained in the Agvet Code and the Agvet Code Regulations.

The limitation on use of information provisions limit the use the APVMA can make of the information given to us:

  • in connection with an application for approval or registration under section 10 of the Agvet Code
  • in connection with an application for variation of the relevant particulars of conditions of approval or under section 27 of the Agvet Code
  • under section 161 (which imposes a standing requirement on certain persons to provide certain information to the APVMA).

The limitation of use provisions are designed to encourage innovation. Limiting the use that the APVMA can make of certain information it obtains makes it easier for people who invest in developing information in support of new regulatory proposals to get a return on that investment.

The Agvet Code also provides separate limitations to the use of information that has been given to the APVMA in relation to an application for registration of certain new chemical products where that information has been disclosed by a government entity or an entity, acting on behalf of a government and that information was not previously publicly available. Further separate use of information limitations also arise in relation to reconsiderations.

There are also provisions limiting the disclosure of confidential commercial information in the Agvet Code. Essentially, disclosure of confidential commercial information, both directly and indirectly, is prohibited unless the disclosure falls within one of the section 162(3) or (7) exemptions. As a general rule confidential commercial information cannot be disclosed to another person or organisation unless the ‘authorising party’ (owner) of this information consents to the disclosure.

General rules about use of information

The APVMA cannot use the following information when:

  • assessing or making a decision on an application made under section 10 or 27
    • information given to the APVMA in connection with another application made under section 10 or 27 by the applicant for the other application, and
    • any new information given to the APVMA under section 161
  • varying relevant particulars or conditions under section 26C, 29A or 29G or reconsidering an approval or registration under Division 4 of Part 2
    • information given to the APVMA in connection with an application made under section 10 or 27 by the applicant for the application, and
    • any new information given to the APVMA under section 161.

The APVMA cannot disclose information that is confidential commercial information. Disclosure can be direct, such as telling someone, or indirect, which would include doing or saying something that effectively allows the person to know the substance of the confidential commercial information even if the information itself is not provided. Section 162 allows for confidential commercial information to be disclosed in a range of circumstances, such as when the authorising party provides express (written) consent to the disclosure.

Information and the use of information

How we define the terms 'information' and 'use of information'.

Limitation periods

Information about the limitation periods for use of information.

Application information

We will not search our information archives to retrieve information we hold, whether its use is limited or not, to support applications.

Information lists

An information list is a list of the details about the information submitted with an application to meet administrative requirements and address the safety, efficacy and trade criteria.

Authorising party

With consent from the authorising party, the APVMA may use information where the use of that information is limited.

Trade-related aspects of intellectual property rights

Information on Australia's obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights.

Exceptions

Exceptions to the general rules regarding how we use information.

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