Document ID: chunk:federal_register_of_legislation:C2024C00508:section:59:p1
Version: federal_register_of_legislation:C2024C00508
Segment Type: section
Provision Reference: s 59 (pt 1/2)
Character Range: 209833–212548

59  Right of originator of protected information to compensation for its use in relation to other applications
 (1) If protected information has been given to the APVMA in relation to:
 (a) a protected active constituent for a proposed or existing chemical product (the primary active constituent); or
 (b) a protected chemical product (the primary chemical product);
the APVMA must not use the information in determining whether to approve, or to continue the approval of, another active constituent for a proposed or existing chemical product (the secondary active constituent), or whether to register, or to continue the registration of, another chemical product (the secondary chemical product).
 (2) Subsection (1) does not apply if:
 (a) the primary holder and the secondary holder:
 (i) have agreed as to the terms of the compensation to be paid by the secondary holder to the primary holder for the information to be used in relation to the secondary active constituent or the secondary chemical product, as the case may be; and
 (ii) have notified the APVMA in writing that they have so agreed and of the terms of the compensation; or
 (b) an arbitrator that the APVMA has appointed has determined the compensation to be so paid and the secondary holder has given notice to the primary holder and to the APVMA stating that the secondary holder agrees to comply with the determination; or
 (c) the protection period (including that period as extended) has elapsed since that information was given to the APVMA; or
 (d) the APVMA is satisfied, having regard to such criteria (if any) as are prescribed, that it is in the public interest for the information to be so used; or
 (e) the information was previously given to the APVMA other than as protected information and Division 4A of Part 2 does not limit the use of the information; or
 (f) the information shows that the secondary active constituent or secondary chemical product may not meet the safety criteria, the trade criteria or the efficacy criteria; or
 (g) the information is publicly available.
 (3) If the APVMA decides to use the information under paragraph (2)(d), the APVMA:
 (a) must give written notice of its decision to the primary holder and the secondary holder; and
 (b) must not make a determination using the information before the end of 28 days after the day on which the notice is given.
 (5) Without affecting the duty of the APVMA to comply with subsection (1):
 (a) the validity of any approval, or continued approval, of the secondary active constituent or the validity of any registration, or continued registration, of the secondary chemical product is not affected by a contravention by the APVMA of that subsection or by