Commonwealth Consolidated Acts

AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT ACT 2013 - SCHEDULE 4

Agricultural and Veterinary Chemicals Code Act 1994

1   Subsection   3(1) of the Code set out in the Schedule (definition of companion animal product )

Repeal the definition.

2   Subsection   3(1) of the Code set out in the Schedule

Insert:

"continue" , an approval or registration, has, for the purposes of Part   3, the meaning given by subsection   59(6).

3   Subsection   3(1) of the Code set out in the Schedule

Insert:

"limitation period" has the meanings given by section   34M.

4   Subsection   3(1) of the Code set out in the Schedule (definition of primary applicant )

Repeal the definition.

5   Subsection   3(1) of the Code set out in the Schedule

Insert:

"primary holder" means:

  (a)   in relation to a primary active constituent--the holder by whom, or on whose behalf, protected information was given to the APVMA in respect of the constituent; or

  (b)   in relation to a primary chemical product--the holder by whom, or on whose behalf, protected information was given to the APVMA in respect of the product.

6   Subsection   3(1) of the Code set out in the Schedule (definition of protected active constituent )

Omit "approved".

7   Subsection   3(1) of the Code set out in the Schedule (definition of protected active constituent )

Omit "both", substitute "each".

8   Subsection   3(1) of the Code set out in the Schedule (at the end of the definition of protected active constituent )

Add:

  ; (c)   the constituent is approved under Part   2.

9   Subsection   3(1) of the Code set out in the Schedule (definition of protected chemical product )

Omit "registered".

10   Subsection   3(1) of the Code set out in the Schedule (definition of protected chemical product )

Omit "both", substitute "each".

11   Subsection   3(1) of the Code set out in the Schedule (after paragraph   ( b) of the definition of protected chemical product )

Insert:

  ; (c)   the product is registered under Part   2.

12   Subsection   3(1) of the Code set out in the Schedule (definition of protected chemical product )

Omit all the words after paragraph   ( b).

13   Subsection   3(1) of the Code set out in the Schedule (definition of protected information )

Repeal the definition, substitute:

"protected information" means information or results given to the APVMA as re quired under paragraph   32(1)(b) or 33(1)(a) or (c) , or subparagraph   159 (1) (d)(i), (ii) or (iii) , that:

  (a)   have been obtained because of a trial or laboratory experiment; and

  (b)   relate to:

  (i)   an active constituent that has been approved; or

  (ii)   a chemical product that has been registered.

14   Subsection   3(1) of the Code set out in the Schedule (definition of protection period )

Repeal the definition, substitute:

"protection period" , in relation to protected information, means the period that:

  (a)   begins when the information is first given to the APVMA in relation to a reconsideration; and

  (b)   ends 8 years after the APVMA makes its decision on the reconsideration.

15   Subsection   3(1) of the Code set out in the Schedule (definition of secondary applicant )

Repeal the definition.

16   Subsection   3(1) of the Code set out in the Schedule

Insert:

"secondary holder" , in relation to a secondary active constituent for a proposed or existing chemical product, means:

  (a)   if the APVMA is considering an application for the approval of that constituent--the person who made the application; or

  (b)   if the APVMA has reconsidered or is reconsidering the approval of that constituent:

  (i)   the person entered in the Record as the holder of the approval; or

  (ii)   if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person--the legal personal representative of the individual or the person administering the individual's affairs; or

  (iii)   if the holder was a body corporate--a successor in law of the body corporate.

17   Subsection   3(1) of the Code set out in the Schedule

Insert:

"secondary holder" , in relation to a secondary chemical product, means:

  (a)   if the APVMA is considering an application for the registration of that product--the person who made the application; or

  (b)   if the APVMA has reconsidered or is reconsidering the registration of that product:

  (i)   the person entered in the Register as the holder of the registration; or

  (ii)   if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person--the legal personal representative of the individual or the person administering the individual's affairs; or

  (iii)   if the holder was a body corporate--a successor in law of the body corporate.

18   Section   34B of the Code set out in the Schedule

Repeal the section, substitute:

34F   Explanation of Division

  (1)   This Division limits the use the APVMA can make of information given to it:

  (a)   in connection with an application under section   10 or 27; or

  (b)   under section   161.

  (2)   Section   34G sets out general rules about the use of information.

  (3)   Section   34H provides that a breach of the rules does not affect the validity of the APVMA's actions.

  (4)   Sections   34J, 34K and 34L set out exceptions to the general rules.

  (5)   Section   34M sets out limitation periods for certain information.

19   Subdivision B of Division   4A of Part   2 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

Subdivision B -- General rules

20   Section   34C of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

34G   General rules

21   Subsection   34C(1) of the Code set out in the Schedule

Repeal the subsection, substitute:

  (1)   The APVMA must not use the following information to assess or make a decision on an application made under section   10 or 27:

  (a)   information given to the APVMA in connection with another application made under section   10 or 27 by the applicant for the other application;

  (b)   information given under section   161.

  (1A)   The APVMA must not use the following information to vary relevant particulars or conditions under section   26C, 29A or 29G or reconsider an approval or registration under Division   4 of Part   2 :

  (a)   information given to the APVMA in connection with an application made under section   10 or 27 by the applicant for the application;

  (b)   information given under section   161.

  (1B)   For the purposes of subsections   ( 1) and (1A), the use of information includes the following:

  (a)   applying a decision made, or a conclusion reached, based on the information;

  (b)   the use of knowledge or understanding gained from the information.

22   After subsection   34C(2) of the Code set out in the Schedule

Insert:

  (3)   A person or body consulted under section   8 or 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992 must not, for the purposes of providing information or advice in relation to an application or reconsideration, use information that the APVMA must not use in determining the application or reconsidering the approval or registration.

23   Before subsection   34C(3) of the Code set out in the Schedule

Insert:

34H   Contraventions of general rules

24   Subsection   34C(3) of the Code set out in the Schedule

Renumber as subsection   ( 1).

25   Subsection   34C(3) of the Code set out in the Schedule

Omit all the words after "contravention of", substitute "section   34G to determine an application, reconsider an approval or registration or vary relevant particulars or conditions does not affect the validity of the determination, the decision on the reconsideration or the relevant particulars or conditions".

26   Subsection   34C(4) of the Code set out in the Schedule

Renumber as subsection   ( 2).

27   Subsection   34C(4) of the Code set out in the Schedule

Omit " subsection   ( 1)", substitute "section   34G".

28   Subparagraph 34C(4)(c)(i) of the Code set out in the Schedule

Repeal the subparagraph.

29   Subdivisions C, D and E of Division   4A of Part   2 of the Code set out in the Schedule

Repeal the Subdivisions, substitute:

Subdivision C -- Exceptions

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.

34K   Further rules about public interest exception

  (1)   This section applies if the APVMA is satisfied under subsection   34J(3) that it is in the public interest to use information.

  (2)   The APVMA must, as soon as practicable, give written notice of its satisfaction to:

  (a)   the applicant for the application in connection with which the information was given; and

  (b)   if the applicant is not the authorising party for the information--the person whom the APVMA believes is the authorising party.

  (3)   The APVMA must not use the information before the end of 28 days after the day on which the notice is given.

  (4)   However, subsection   ( 3) does not apply if:

  (a)   the APVMA believes it is necessary to use the information before the end of 28 days after the notice is given, to prevent imminent risk to persons of death, serious injury or serious illness; and

  (b)   states that belief in the notice.

34L   Information with limitation periods

    Section   34G does not prevent the APVMA from using information to which a limitation period applies:

  (a)   after the limitation period has ended; or

  (b)   to reconsider an approval or registration under Division   4 of Part   2 if the decision on the reconsideration is made after the limitation period has ended.

Note:   Information given in connection with an application made under section   10 or 27 has a limitation period only if the information was relied on to :

(a)   approve or register the constitu ent, product or label concerned ; or

(b)   vary the relevant particulars or conditions concerned .

  Information that does not have a limitation period is protected indefinitely.

34M   Limitation periods

  (1)   The table below sets out limitation periods for certain information given in connection with an application made under section   10 or 27:

  (2)   The table below sets out limitation periods for information given under section   161:

30   Paragraph 57(2)(b) of the Code set out in the Schedule

Repeal the paragraph, substitute:

  (b)   the information was obtained because of a trial or laboratory experiment and any of the following apply:

  (i)   the information is of a kind mentioned in paragraph   32(1)(b) and was given to the APVMA in response to a notice under that section;

  (ii)   the trial or laboratory experiment was conducted in response to a notice under section   33;

  (iii)   the information was given to the APVMA in response to a notice under subsection   159(1) for the purposes of sub paragraph   159(1)(d) (i), (ii) or (iii) .

31   Subsection   57(2) of the Code set out in the Schedule

Omit all the words after paragraph   ( b).

32   Subsection   57(3) of the Code set out in the Schedule

Repeal the subsection.

33   Section   58 of the Code set out in the Schedule

Repeal the section.

34   Subsection   59(1) of the Code set out in the Schedule

Omit all the words from and including " Subject to subsections   ( 1A) and (2) " to and including " protected information ", substitute " I f protected information ".

35   Paragraph 59(1)(c) of the Code set out in the Schedule

Renumber as paragraph   ( a) .

36   Paragraph 59(1)(d) of the Code set out in the Schedule

Renumber as paragraph   ( b) .

37   At the end of subsection   59(1) of the Code set out in the Schedule

Add:

Note:   In this Part:

(a)   approve does not include re - approve; and

(b)   register does not include re - register.

  See the definitions of approve and register in subsection   3(1).

38   Subsection   59(1A) of the Code set out in the Schedule

Repeal the subsection.

39   Subsection   59(2) of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

40   At the end of subsection   59(2) of the Code set out in the Schedule

Add:

  ; or (e)   the information wa s previously given to the APVMA other than as protected information and neither of the following applies :

  (i)   the information was given only in response to an invitation under paragraph   8S(2)(e) in relation to an application for re - approval of the primary active constituent or re - registration of the primary chemical product ;

  (i i )   Division   4A of Part   2 l imit s 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.

41   Paragraph 59(3) (a) of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

42   Subsection   59(4) of the Code set out in the Schedule

Repeal the subsection.

43   Paragraph 59(5)(a) of the Code set out in the Schedule

Omit "applicant", substitute "holder".

44   At the end of section   59 of the Code set out in the Schedule

Add:

  (6)   In this Part, continue an approval or registration means:

  (a)   vary the relevant particulars or conditions of the approval or registration, other than under Division   3A of Part   2 (re - approving and re - registering); or

  (b)   affirm the approval or registration under Division   4 of Part   2 (reconsidering approvals and registrations).

45   Section   60 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

60   APVMA to notify holders

45A   Paragraph 60(1)(b)

Omit "paragraph   59(2)(c)", substitute "subsection   59(2)".

46   Subsection   60(2) of the Code set out in the Schedule

Omit "secondary applicant" (first occurring) , substitute "primary holder or each primary holder and to the secondary holder".

47   Paragraph 60(2)(b) of the Code set out in the Schedule

Omit ", (b) or (d)", substitute "or (b)".

48   Paragraph 60(2)(c) of the Code set out in the Schedule

Repeal the paragraph, substitute:

  (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.

49   Subsection   60(3) of the Code set out in the Schedule

Omit "the secondary applicant" (first occurring), substitute "a notice recipient".

50   Subsection   60(3) of the Code set out in the Schedule

After "the APVMA must", insert ", within 14 days,".

51   Subsection   60(3) of the Code set out in the Schedule

Omit "primary applicant" (first and second occurring), substitute "primary holder".

52   Subsection   60(3) of the Code set out in the Schedule

Omit "secondary applicant" (second occurring), substitute "secondary holder".

53   Paragraph 60(3)(a) of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

54   Paragraph 60(3)(b) of the Code set out in the Schedule

Omit "applicant", substitute "holder".

55   Paragraph 60(3)(b) of the Code set out in the Schedule

Omit ", (b) or (d)", substitute "or (b)".

56   Paragraphs 60(3)(c) and (e) of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

57   Section   61 of the Code set out in the Schedule (heading)

Repeal the heading, substitute:

61   Primary holder to notify secondary holder

58   Subsection   61(1) of the Code set out in the Schedule

Omit "As soon as practicable", substitute "Within 28 days".

59   Subsection   61(1) of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

60   Subsection   61(1) of the Code set out in the Schedule

Omit "section   60", substitute "subsection   60(3)".

61   Section   62 of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

62   Paragraph 62(1)(b) of the Code set out in the Schedule

Omit "applicants", substitute "holders".

63   S ubs ection   62(1) of the Code set out in the Schedule

Omit "and the secondary", substitute "and any".

64   Section   69 of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

65   Section   70 of the Code set out in the Schedule

Omit "applicant" (wherever occurring), substitute "holder".

66   Subsection   70(1) of the Code set out in the Schedule

Omit "applicants", substitute "holders".

67   Subsection   71(1) of the Code set out in the Schedule

Omit "section", substitute "Division".

68   Section   169 of the Code set out in the Schedule

Before "When", insert "(1)".

69   At the end of section   169 of the Code set out in the Schedule

Add:

  (2)   Subsection   ( 1) is not limited by section   14B, Division   4A of Part   2 or Part   3.