60APVMA to notify holders

#### 60 APVMA to notify holders (1) This section applies if: (a) the APVMA is unable to complete its consideration of: (i) the approval or continued approval of an active constituent for a proposed or existing chemical product; or (ii) the registration or continued registration of a secondary chemical product; under this Code unless it uses protected information; and (b) paragraph 59(2) does not permit the APVMA to use the information. (2) The APVMA must give to the primary holder or each primary holder and to the secondary holder written notice: (a) stating that the APVMA’s consideration of: (i) the approval or continued approval of the secondary active constituent; or (ii) the registration or continued registration of the secondary chemical product; cannot be completed unless the APVMA uses the information; and (b) stating that the APVMA is precluded from using the information except in circumstances prescribed by paragraph 59(2)(a) or (b) and setting out those circumstances; and (c) requesting the notice recipient to tell the APVMA, before the day stated in the notice, which must be within 60 days after the notice is given, whether the notice recipient wants the APVMA to take further action in respect of the information under this section. (3) If a notice recipient tells the APVMA that it wants the APVMA to take further action in respect of the information under this section, the APVMA must, within 14 days, give to the primary holder or each primary holder and to the secondary holder written notice: (a) containing: (i) in respect of the notice to a primary holder—the prescribed information about the secondary holder and about the secondary active constituent or the secondary chemical product, as the case may be; or (ii) in respect of the notice to the secondary holder—the prescribed information about the primary holder and about the primary active constituent or the primary chemical product, or about each primary holder and about each primary active constituent or primary chemical product, as the case may be; and (b) stating that the APVMA’s consideration of the approval or continued approval of the secondary active constituent, or of the registration or continued registration of the secondary chemical product, cannot be completed unless the APVMA uses protected information given by a primary holder but the APVMA is precluded from using that information except in circumstances prescribed by paragraph 59(2)(a) or (b) and setting out those circumstances; and (c) inviting the primary holder or each primary holder, and the secondary holder, within a period stated in the notice, to negotiate as to the terms of the compensation to be paid by the secondary holder to that primary holder for the use of that information and to give written notice to the APVMA of the results of the negotiation; and (d) telling them that, if they are unable to agree as to the terms of the compensation: (i) a mediator will be appointed to try to help them to reach agreement; and (ii) if the mediation is not successful, an arbitrator will be appointed to determine those terms in accordance with any reasonable proposals made in the course of the negotiations (including negotiations during the period of the mediation); and (iii) if the arbitrator finds that no reasonable proposals were made, the APVMA may suspend the approval of the primary active constituent or the registration of the primary chemical product (as the case may be), or the approval of the secondary active constituent or the registration of the secondary chemical product (as the case may be), or both; and (e) telling them of the obligations imposed on the primary holder or each primary holder under section 61.