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Agriculture, Fisheries and Forestry Legislation Amendment Bill (No. 2) 1998
Schedule 1 Amendment of the Agricultural and Veterinary Chemicals (Administration) Act 1992

   

1  After Part 7A

Insert:

Part 7B Modification of the Agvet Codes for the purpose of giving effect to paragraph 3 of Article 39 of the TRIPS Agreement

   

69EV   Definitions

             (1)  In this Part:

current application has the meaning given by section 69EX.

information includes, but is not limited to, information obtained from trials or laboratory experiments.

previous application has the meaning given by section 69EX.

relevant information has the meaning given by section 69EX.

             (2)  Expressions used in this Part that are defined or otherwise used in the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 have the same meanings as in that Code.

69EW   Modification of Agvet Codes

             (1)  This Part modifies the Agvet Codes for the purpose of giving effect to Australia’s obligations under paragraph 3 of Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights set out in Annex 1C to the Marrakesh Agreement establishing the World Trade Organization, done at Marrakesh on 15 April 1994.

Note:          The English text of the Marrakesh Agreement establishing the World Trade Organization is set out in Australian Treaty Series 1995 No. 8.

             (2)  The Agvet Codes have effect subject to this Part.

69EX   Application of Part

                   This Part applies to an application (the current application ) made to the NRA after the commencement of this Part for approval of an active constituent for a proposed or existing chemical product where:

                     (a)  the NRA cannot grant the application without using information (the relevant information ) given to the NRA in connection with a previous application (the previous application ) made to the NRA (other than a previous application made before the commencement of this Part) for approval of an active constituent for a proposed or existing chemical product; and

                     (b)  the relevant information has not been made publicly available in Australia; and

                     (c)  at the time immediately before the previous application was made, no application had been made to the NRA for approval of the active constituent to which that application related.

69EY   NRA not to grant current application except in certain circumstances

                   The NRA must not grant the current application unless:

                     (a)  the person who made that application:

                              (i)  has given to the NRA information that makes it unnecessary for the NRA to use the relevant information in connection with that application; or

                             (ii)  has given to the NRA evidence that satisfies the NRA that the person who made the previous application has consented to the NRA using the relevant information in connection with the current application; or

                     (b)  at least 5 years have elapsed since the previous application was determined by the NRA or was withdrawn, as the case may be.

69EZ   Approval given in contravention of section 69EY is not invalid but is to be cancelled

             (1)  If:

                     (a)  the NRA approves an active constituent for a proposed or existing chemical product; and

                     (b)  the NRA was prohibited by section 69EY from giving the approval;

the approval is not invalid.

             (2)  However, the NRA must cancel the approval when it finds out that the giving of the approval was prohibited by section 69EY.

69EZA   Power of NRA to grant multiple approvals to be subject to section 69EY

                   The power of the NRA under subsection 16(1) of the Agvet Codes to approve the same active constituent for a proposed or existing chemical product on applications made by different persons is subject to section 69EY.

69EZB   Power of NRA to use information obtained by it for other purposes not to be affected

                   Except as provided by section 69EY, the power of the NRA under subsection 58(1) of the Agvet Codes to use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under those Codes is not affected.