US FREE TRADE AGREEMENT IMPLEMENTATION ACT 2004 NO. 120, 2004 - SCHEDULE 2 - Agricultural and veterinary chemicals amendments

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US FREE TRADE AGREEMENT IMPLEMENTATION ACT 2004 NO. 120, 2004 - SCHEDULE 2

- Agricultural and veterinary chemicals amendments Part 1—Limits on use of information

Agricultural and Veterinary Chemicals Code Act 1994

1 After Division 4 of Part 2 of the Schedule

Insert:

Division 4A—Limits on use of information
Subdivision A—Preliminary
34B Explanation of Division

(1): This Division limits for a period the use the NRA can make of information given to it:

(a) in connection with an application under section 10 or 27 relating to:
(i) approval of an active constituent for a chemical product; or
(ii) registration of a chemical product; or
(iii) approval of a label for a container for a chemical product; or
(b) under section 161 in connection with a registered chemical product.

(2): During the period, the NRA cannot use the information for granting another application, or for a reconsideration of an approval or registration, unless:

(a) the NRA is given a written statement made by a person who can authorise the use of the information consenting to the use; or
(b) certain other conditions are met.

(3): The object of limiting use of the information in this way is to encourage innovation by making it easier for a person who made an investment in finding out the information to get a return on that investment.

Subdivision B—Limits on use of information
34C NRA must not use some information during some periods for some purposes

(1): During the period described in an item of the table, the NRA must not use information described in the item for a purpose described in the item.

Limits on use of information
	The NRA must not use this information:	During this period:	For this purpose:
1	Information that the applicant or an approved person gives the NRA: (a) in connection with an application under section 10 or 27; and (b) before the NRA makes a preliminary assessment under section 11A or 28A of the application	The period: (a) starting when the information is given; and (b) ending when the NRA makes the preliminary assessment	Making a decision under section 14, 29 or 34 (except a decision on the application)
2	Information that the applicant or an approved person gives the NRA: (a) in connection with an application under section 10 or 27; and (b) as required by the NRA or section 160A	The period: (a) starting when the NRA makes a preliminary assessment under section 11A or 28A of the application; and (b) ending when the NRA treats the application as having been withdrawn or grants or refuses the application	Making a decision under section 14, 29 or 34 (except a decision on the application)
3	Information that: (a) was given to the NRA by the applicant or an approved person in connection with an application under section 10 or 27; and (b) was given as required by the NRA or section 160A; and (c) was relied on by the NRA to grant the application	The relevant period described in section 34F	Making a decision under section 14, 29 or 34
4	Information that the interested person for a registered chemical product gives the NRA under section 161 in connection with the product	The period: (a) starting when the person gives the NRA the information; and (b) ending 5 years later if the product is an agricultural chemical product or 3 years later if the product is a veterinary chemical product	Making a decision under section 14, 29 or 34

Note 1: Section 34D sets out exceptions to this subsection.

Note 2: Section 161 may require an interested person for an approved active constituent to give the NRA information in connection with the constituent, even though this table does not deal with that requirement.

(2): This section applies only to information given to the NRA:

(a) in connection with an application made after the commencement of this section; or
(b) under section 161 in connection with a chemical product that was registered as a result of an application made after the commencement of this section.

(3): The use of information in contravention of subsection (1) for making a decision does not affect the validity of the decision.
(4): An action or proceeding does not lie against any of the following for any loss directly or indirectly sustained because of the use of information in contravention of subsection (1):

(a) the Commonwealth;
(b) the NRA;
(c) a person who is or has been:
(i) a director of the NRA; or
(ii) the Chief Executive Officer of the NRA; or
(iii) a delegate of the NRA; or
(iv) a member of the staff of the NRA.

Subdivision C—Exceptions to limits on use of information
34D Exceptions

(1): Section 34C does not prevent the NRA from using information for making a decision:

(a) under section 14 or 29 about an application; or
(b) under section 34 about a reconsideration of an approval or registration;

if a condition in subsection (2), (3), (4), (5) or (6) of this section is met.

Evidence of consent for use

(2): One condition is that the applicant, an approved person or the interested person for the approval or registration gives the NRA a written statement by the authorising party of that party's consent to the NRA using the information for making the decision. 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 NRA is given the statement of 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 NRA 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 34E sets out other rules that are relevant to the exception based on this condition.

Information does not favour the applicant or interested person

(4): Another condition is that:

(a) the decision 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 meets a condition in paragraph 160A(4)(b) or (c) or 161(2)(b) or (c) (which are about showing that use or dealing with the product may have adverse effects or that the product may be ineffective), whether or not the information was given to the NRA under section 160A or 161.

Identical information whose use is not limited

(5): Another condition is that the NRA is satisfied that there is identical information, or information to the same effect, whose use is not prevented by section 14B or 34C or Part 3.

Information given to NRA in connection with certain applications

(6): Another condition is that the application mentioned in subsection 34C(1) was one of the following:

(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;
(b) an application for the variation of the relevant particulars or conditions of the approval of an active constituent for a chemical product;
(c) an application for the registration of a companion animal product each active constituent for which was a previously endorsed active constituent at the time of the preliminary assessment of the application under section 11A;
(d) an application for variation of the relevant particulars or conditions of the registration of a companion animal product;
(e) an application for the approval of a label for a container for a companion animal product each active constituent of which was a previously endorsed active constituent at the time of the preliminary assessment of the application under section 11A;
(f) an application for variation of the relevant particulars or conditions of the approval of a label for a container for a companion animal product.

34E Further rules about public interest exception

(1): This section applies if the NRA is satisfied under subsection 34D(3) that it is in the public interest to use information that section 34C would otherwise prohibit the NRA from using for making a decision:

(a) under section 14 or 29 about an application; or
(b) under section 34 about a reconsideration of an approval or registration.

(2): As soon as practicable after becoming satisfied, the NRA must give written notice of its satisfaction to:

(a) the applicant, an approved person or the interested person for the approval or registration; and
(b) the person whom the NRA believes is the authorising party for the information.

(3): Section 168 provides for additional matters to be included in the notice.
(4): The NRA must not make the decision using the information before the end of 28 days after the day on which the notice is given.
(5): However, subsections (3) and (4) do not apply if:

(a) the NRA believes it is necessary to make the decision before the end of 28 days after the notice is given, to prevent imminent risk to public health or occupational health or safety; and
(b) states that belief in the notice.

Subdivision D—Period of limit on use of information
34F Period of limit on future use of information relied on in granting application

(1): Subsection 34C(1) prohibits the NRA from using, during the period described in an item of the following table, information that:

(a) was given to the NRA by the applicant or an approved person in connection with an application described in the item; and
(b) was given as required by the NRA or section 160A; and
(c) was relied on by the NRA to grant the application.

The period starts when the application was granted.

Period for which the NRA must not use the information
	Application	Period
1	Application made under section 10 for approval of an active constituent (for a proposed or existing chemical product) that was not a previously endorsed active constituent on the commencement of this Division	8 years
2	Application made under section 10 for: (a) registration of a chemical product at least one of whose active constituents was not a previously endorsed active constituent when the application was acknowledged; or (b) approval of a label for a container for a chemical product at least one of whose active constituents was not a previously endorsed active constituent when the application was acknowledged	8 years
3	Application (except one covered by item 2) made under section 10 for: (a) registration of an agricultural chemical product; or (b) approval of a label for a container for an agricultural chemical product	5 years
4	Application (except one covered by item 2) made under section 10 for: (a) registration of a veterinary chemical product; or (b) approval of a label for a container for a veterinary chemical product	3 years
5	Application made under section 27 for variation of the relevant particulars or conditions of: (a) the registration of an agricultural chemical product; or (b) the approval of a label for a container for an agricultural chemical product	5 years
6	Application made under section 27 for variation of the relevant particulars or conditions of: (a) the registration of a veterinary chemical product; or (b) the approval of a label for a container for a veterinary chemical product	3 years

Note 1: This section has effect for the purposes of item 3 of the table in subsection 34C(1) (and not for any of the other items in that table).

Note 2: This section is not relevant to information if section 34D provides an exception to the prohibition in subsection 34C(1) on the NRA using the information.

Extension of 8-year limits

(2): The period mentioned in item 1 or 2 of the table in subsection (1) in relation to:

(a) an application for an approval of an active constituent (a key constituent ); or
(b) an application for registration of a chemical product containing an active constituent (also a key constituent ) that had not been approved when the application was acknowledged; or
(c) an application for approval of a label for a container for a chemical product containing an active constituent (also a key constituent ) that had not been approved when the application was acknowledged;

is extended by 1 year for each 5 distinct uses that meet the requirements in subsections (3), (4) and (5).

(3): The first requirement is that the uses are uses of a chemical product (an extension product ) for which the following conditions are met:

(a) the key constituent is an active constituent for the product;
(b) the product was registered as a result of an application that:
(i) was made by the applicant mentioned in subsection (1); and
(ii) was acknowledged before the approval of the key constituent.

(4): The second requirement is that each of the uses is included in an approved label for a container for an extension product as a result of an application that:

(a) is for:
(i) the approval of the label; or
(ii) the variation of the relevant particulars or conditions of approval of the label; and
(b) was made by the applicant mentioned in subsection (1) or by the interested person in relation to the approval of the key constituent; and
(c) was acknowledged before the end of 6 years after the date of the approval of the key constituent as a result of an application by the applicant mentioned in subsection (1).

(5): The third requirement is that all 5 of the uses are prescribed by the regulations at the latest time an application described in subsection (4) is granted.
(6): However, the period mentioned in item 1 or 2 of the table in subsection (1) cannot be extended so that it exceeds 11 years.

Subdivision E—Ancillary provisions
34G Identifying information relied on in advice NRA relied on

(1): This section has effect if:

(a) the NRA made a decision under subsection 14(1) or 29(1) to grant an application made after the commencement of this section; and
(b) in making the decision, the NRA relied on advice given by a person, body or Government the NRA consulted under section 8 or 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992 .

(2): The NRA must cause to be published a summary of the advice.
(3): The summary must:

(a) identify the information that the person, body or Government relied on in giving the advice; and
(b) include the matters (if any) prescribed by the regulations.

Part 2—Provisions relating to limits on use of information

Agricultural and Veterinary Chemicals (Administration) Act 1992

2 Paragraph 69EX(a)

After "Part", insert "or after the commencement of Division 4A of Part 2 of the Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 ".

Agricultural and Veterinary Chemicals Code Act 1994

3 Section 3 of the Schedule

Insert:

acknowledge an application made under section 10 or 27 has the meaning given in the table:

Acknowledgment of an application
	If:	The application is acknowledged when:
1	The NRA gives notice under subsection 11A(2) (applying of its own force or because of section 28A) that the application has passed a preliminary assessment and will be given a full evaluation in due course	The NRA gives the notice
2	The NRA is satisfied that defects in the application have been rectified as required by a notice given under paragraph 11A(3)(a) (applying of its own force or because of section 28A)	The NRA becomes satisfied
3	The NRA starts to consider the application after deferring the consideration under subparagraph 11A(3)(b)(i) (applying of its own force or because of section 28A)	The NRA starts to consider the application

4 Section 3 of the Schedule

Insert:

"authorising party" for information means a person who would be entitled to bring an action for breach of an obligation of confidence if the information were disclosed by someone else to the NRA for the purposes of this Code without the person's permission.

5 Section 3 of the Schedule

Insert:

"companion animal product" means a veterinary chemical product solely for administration or application to animals that:

(a) are not food-producing species; and
(b) are not prescribed by the regulations.

6 Section 3 of the Schedule

Insert:

"previously endorsed active constituent" for a chemical product at a particular time means a substance that:

(a) before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as an active constituent for a chemical product; or
(b) was an active constituent for a chemical product that, before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as a chemical product;

whether or not the approval or registration was a result of an application by a particular person.

7 After section 11A of the Schedule

Insert:

11B NRA to publish summary of application

(1): As soon as practicable after an application is acknowledged, the NRA must cause to be published a summary of the application.
(2): The summary must include the details relating to the application that are prescribed by the regulations (if any).

8 After section 14A of the Schedule

Insert:

14B NRA not to use information for registration of new agricultural >chemical product to approve a similar product after disclosure

(1): This section applies if:

(a) information was given to the NRA in connection with an application made after the commencement of this section for registration of an agricultural chemical product (the first product ) containing an active constituent that was not a previously endorsed active constituent at the time of registration of the first product; and
(b) the information related to the first product or the active constituent and a matter that:
(i) is described in paragraph 14(3)(e) (except subparagraph 14(3)(e)(iv)) or paragraph 14(3)(f); or
(ii) is prescribed by the regulations; and
(c) the information was disclosed:
(i) by the Commonwealth, a State or a Territory; or
(ii) by an authority of the Commonwealth, a State or a Territory (including the NRA); or
(iii) by anyone acting on behalf of the Commonwealth, a State, a Territory or an authority of the Commonwealth, a State or a Territory; and
(d) the information was not publicly available before the disclosure; and
(e) as a result of the disclosure, the interested person, or an approved person, for an application for registration of an agricultural chemical product (the second product ) that is the same as, or similar to, the first product, seeks to have the NRA use the information in granting the application.

(2): For 10 years after the first day on which the first product was registered, the NRA must not use the information to grant the application for registration of the second product if:

(a) the registration of the second product would be commercially unfair; and
(b) the authorising party for the information does not consent to the use.

(3): The use of information in contravention of subsection (2) for granting the application for registration of the second product does not affect the validity of the grant or of the registration of the second product.
(4): An action or proceeding does not lie against any of the following for any loss directly or indirectly sustained because of the use of information in contravention of subsection (2):

(5): This section has effect in addition to Division 4A.

9 Subparagraph 15(1)(a)(i) of the Schedule

Repeal the subparagraph, substitute:

(i) the NRA also grants or has granted an application for approval of each active constituent for the product; and

10 After section 28 of the Schedule

Insert:

28A Preliminary assessment of application

Section 11A applies to an application lodged under section 28 and compliance with subsection 28(1) in the same way as it applies to an application lodged under section 11 and compliance with subsection 11(1).

28B NRA to publish summary of application

(1): As soon as practicable after an application is acknowledged, the NRA must cause to be published a summary of the application, unless satisfied that the variation applied for does not relate to use of or dealing with a proposed or existing chemical product.
(2): The summary must include the details relating to the application that are prescribed by the regulations (if any).

11 Subsection 58(1) of the Schedule

After "in", insert "section 14B, Division 4A of Part 2 and".

12 After paragraph 167(1)(b) of the Schedule

Insert:

(ba) a decision under section 28A that the application does not comply with subsection 28(1);
(bb) a decision under section 28A:
(i) to defer consideration of an application to vary the relevant particulars, or the conditions, of an approval or registration; or
(ii) to treat such an application as having been withdrawn; or
(iii) to reject such an application;
(bc) a decision under section 28A refusing to extend a period;

13 After paragraph 167(1)(e) of the Schedule

Insert:

(ea) a decision (the information decision ) under subsection 34D(3) that the NRA is satisfied that it is in the public interest to use information that section 34C would otherwise prohibit the NRA from using for making a decision (the substantive decision ):
(a) under section 14 or 29 about an application; or
(b) under section 34 about a reconsideration of an approval or registration;

14 After subsection 167(2) of the Schedule

Insert:

(2A): Despite paragraph (1)(ea), an application may not be made to the Administrative Appeals Tribunal for review of the information decision if the NRA stated in the notice of that decision given under section 34E that the NRA believed it was necessary to make the substantive decision before the end of 28 days after giving the notice, to prevent imminent risk to public health or occupational health or safety.

Part 3—Change of name from NRA to APVMA

Agricultural and Veterinary Chemicals Code Act 1994

15 Section 3 of the Schedule (definition of acknowledge )

Omit "NRA" (wherever occurring), substitute "APVMA".

16 Section 3 of the Schedule (definition of authorising
party )

Omit "NRA", substitute "APVMA".

17 Sections 11B and 14B of the Schedule

Omit "NRA" (wherever occurring), substitute "APVMA".

Note: The headings to sections 11B and 14B of the Schedule are altered by omitting "NRA" and substituting "APVMA".

18 Subparagraph 15(1)(a)(i) of the Schedule

Omit "NRA", substitute "APVMA".

19 Subsection 28B(1) of the Schedule

Omit "NRA", substitute "APVMA".

Note: The heading to section 28B of the Schedule is altered by omitting "NRA" and substituting "APVMA".

20 Division 4A of Part 2 of the Schedule

Omit "NRA" (wherever occurring), substitute "APVMA".

Note: The headings to sections 34C and 34G of the Schedule are altered by omitting "NRA" and substituting "APVMA".

21 Section 167 of the Schedule

Omit "NRA" (wherever occurring), substitute "APVMA".

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