Document ID: chunk:federal_register_of_legislation:C2014C00508:clause:4_34j
Version: federal_register_of_legislation:C2014C00508
Segment Type: clause
Provision Reference: sch 4 cl 34J
Character Range: 411565–414110

34J  Consent, public interest etc.
 (1) Section 34G does not prevent the APVMA from using information if a condition in this section is met.

Consent to use
 (2) One condition is that the authorising party gives written consent to the use of the information. This condition is met even if the authorising party:
 (a) later states that it has not consented; or
 (b) withdraws the consent (whether before or after the APVMA is given the consent).
Note: Chapter 7 of the Criminal Code creates offences relating to false and misleading statements and forgery.

Use in the public interest
 (3) Another condition is that the APVMA is satisfied, having regard to the criteria (if any) prescribed by the regulations, that the use of the information is in the public interest.
Note: Section 34K sets out other rules that are relevant to the exception based on this condition.

Information does not favour the applicant or holder
 (4) Another condition is that:
 (a) the information relates to:
 (i) a proposed or existing approval of an active constituent for a proposed or existing chemical product; or
 (ii) a proposed or existing registration of a proposed or existing chemical product; and
 (b) the information shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.

Information given again
 (5) Another condition is that the information:
 (a) is given to the APVMA in connection with an application and is used to assess or make a decision on the application; or
 (b) is given to the APVMA in connection with the reconsideration, under Division 4 of Part 2, of an approval or registration and is used to reconsider the approval or registration.

Protected information whose protection period has expired
 (5A) Another condition is that the information is protected information whose protection period has expired.
Note: For protected information and protection period, see subsection 3(1) and Part 3.

Information is publicly available
 (5B) Another condition is that the information is publicly available.

Information given to APVMA in connection with certain applications
 (6) Another condition is that the information was given in connection with:
 (a) an application for approval, as an active constituent for a chemical product, of a substance that was a previously endorsed active constituent on the commencement of this Division; or
 (b) an application for the variation of the relevant particulars or conditions of the approval of an active constituent for a chemical product.