Agricultural Compounds and Veterinary Medicines Amendment Act 2016

1: Title
This Act is the Agricultural Compounds and Veterinary Medicines Amendment Act 2016.
2: Commencement
This Act comes into force on the day after the date on which it receives the Royal assent.
3: Principal Act
This Act amends the Agricultural Compounds and Veterinary Medicines Act 1997 principal Act 2016-11-08 Agricultural Compounds and Veterinary Medicines Act 1997
1: Substantive amendments to principal Act
4: New section 2A inserted (Transitional, savings, and related provisions)
After section 2
2A: Transitional, savings, and related provisions
The transitional, savings, and related provisions set out in Schedule 1
5: Section 29 amended (Reassessment of trade name products)
Replace section 29(3)
3: A decision under subsection (1) is deemed to be a new application for the trade name product, and—
a: sections 11, 12, and 17 to 25 apply to the application with any necessary modifications; and
b: Part 6 applies to the application as if it were a non-innovative TNP application, and with any other necessary modifications.
6: Section 30 amended (Reassessment of provisional registration)
Replace section 30(3)
3: A decision under subsection (1) is deemed to be a new application for provisional registration for the trade name product, and—
a: sections 26 and 27 apply to the application with any necessary modifications; and
b: Part 6 applies to the application as if it were a non-innovative TNP application, and with any other necessary modifications.
7: Section 56 amended (Penalties)
1: In section 56(3) Subject to subsection (4), every Every
2: Repeal section 56(4)
8: Part 6 replaced
Replace Part 6
6: Protection of confidential information about trade name products
Interpretation
72: Interpretation
1: In this Part, unless the context otherwise requires,— application to authorise a new use or method of use
a: a purpose of use described in paragraph (a) or (b)﻿(i) or (ii) of the definition of agricultural compound in section 2(1); or
b: 1 or more of the following:
i: the rate at which the product must be applied:
ii: when the product must or must not be applied:
iii: how the product must be applied:
iv: the withholding period for the product confidential information section 73 innovative TNP application
a: the ingredient is referred to in the application as an active ingredient of the trade name product; and
b: at the time the Director-General receives the application, the ingredient has not previously been an active ingredient of—
i: a trade name product registered under section 21; or
ii: a pesticide that was registered under the Pesticides Act 1979; or
iii: an animal remedy the manufacture or importation of which was licensed under the Animal Remedies Act 1967 (otherwise than by a provisional licence) innovative trade name product non-innovative TNP application non-innovative trade name product protected period section 74
2: The grant of an experimental use permit for a pesticide under section 25 of the Pesticides Act 1979 does not constitute the registration of that pesticide for the purposes of paragraph (b)﻿(ii)
73: Meaning of confidential information
1: In this Part, confidential information
a: is provided in support of an innovative TNP application, a non-innovative TNP application, or an application to authorise a new use or method of use; and
b: is confidential information about the trade name product that is the subject of that application.
2: For the purposes of subsection (1)﻿(b)
a: trade secrets; and
b: information with a commercial value that would, or would be likely to, be diminished by disclosure of the information.
74: Meaning of protected period
In this Part, protected period
a: for confidential information supporting an innovative TNP application made under section 9(1), the period specified in section 74B:
b: for confidential information supporting an innovative TNP application made under section 26, the period specified in section 74C:
c: for confidential information supporting an application to authorise a new use or method of use for an innovative trade name product, the period specified in section 74D:
d: for confidential information supporting a non-innovative TNP application made under section 9(1), the period specified in section 74E:
e: for confidential information supporting a non-innovative TNP application made under section 26, the period specified in section 74F
f: for confidential information supporting an application to authorise a new use or method of use for a non-innovative trade name product, the period specified in section 74G. Director-General must protect confidential information during protected period
74A: Director-General must protect confidential information during protected period
1: The Director-General must, during the protected period that applies to confidential information,—
a: take reasonable steps to ensure that the confidential information is kept confidential to the Director-General; and
b: not use the confidential information in determining whether to grant any other innovative TNP application, non-innovative TNP application, or application to authorise a new use or method of use.
2: This section is subject to section 74H Protected periods for information about innovative trade name products
74B: Innovative TNP application for full registration
1: The protected period for confidential information supporting an innovative TNP application under section 9(1) starts when the Director-General receives the application.
2: The protected period ends on the date that is 10 years after the date on which the Director-General grants or refuses to grant the application.
74C: Innovative TNP application for provisional registration
1: The protected period for confidential information supporting an innovative TNP application under section 26 starts when the Director-General receives the application.
2: The protected period ends on the date that is 5 years after the date on which the Director-General grants or refuses to grant the application, unless subsection (3)
3: The protected period continues until the end of the protected period for confidential information supporting an innovative TNP application subsequently made under section 9(1) if—
a: the application under section 9(1) is for the same trade name product; and
b: the confidential information given in support of the application under section 26 is also given in support of the application under section 9(1); and
c: the confidential information supporting the application under section 9(1) is received by the Director-General before the period specified in subsection (2)
74D: Application to authorise new use or method of use
1: The protected period for confidential information supporting an application to authorise a new use or method of use for an innovative trade name product starts when the Director-General receives the application.
2: The protected period ends on the later of—
a: the end date of the protected period for confidential information supporting the innovative TNP application that resulted in the registration of the product; and
b: the date that is 5 years after the date on which the Director-General grants or refuses to grant the application to authorise a new use or method of use. Protected periods for information about non-innovative trade name products
74E: Non-innovative TNP application for full registration
1: The protected period for confidential information supporting a non-innovative TNP application under section 9(1) starts when the Director-General receives the application.
2: The protected period ends on the date that is 5 years after the date on which the Director-General grants or refuses to grant the application.
74F: Non-innovative TNP application for provisional registration
1: The protected period for confidential information supporting a non-innovative TNP application under section 26 starts when the Director-General receives the application.
2: The protected period ends on the date that is 5 years after the date on which the Director-General grants or refuses to grant the application, unless subsection (3)
3: The protected period continues until the end of the protected period for confidential information supporting a non-innovative TNP application subsequently made under section 9(1) if—
a: the application under section 9(1) is for the same trade name product; and
b: the confidential information given in support of the application under section 26 is also given in support of the application under section 9(1); and
c: the confidential information supporting the application under section 9(1) is received by the Director-General before the period specified in subsection (2)
74G: Application to authorise new use or method of use
1: The protected period for confidential information supporting an application to authorise a new use or method of use for a non-innovative trade name product starts when the Director-General receives the application.
2: The protected period ends on the date that is 5 years after the date on which the Director-General grants or refuses to grant the application. Director-General may disclose or use confidential information
74H: Director-General may disclose or use confidential information
1: In this section, application
2: Despite section 74A
3: The Director-General may disclose the information, or use it in determining whether to grant an application other than the application to which the information relates or related, if—
a: the applicant who made the application to which the information relates or related has consented in writing to the disclosure or use of the information; or
b: the Director-General forms the opinion that the disclosure or use is necessary to protect the health or safety of members of the public.
4: The Director-General may disclose the confidential information to 1 or more of the following persons or organisations if the Director-General is of the opinion that they will take reasonable steps to ensure that they will not disclose the information to any other person:
a: a government department or statutory body for the purposes of that government department or statutory body:
b: an adviser for the purposes of obtaining advice about the agricultural compound to which the information relates:
c: the World Health Organization:
d: the Office International des Epizooties:
e: the Food and Agriculture Organization:
f: a regulatory agency of a country that is a party to the Agreement Establishing the World Trade Organization adopted at Marrakesh on 15 April 1994 (commonly known as a WTO country):
g: a prescribed person or organisation or a person or an organisation within a prescribed class or prescribed classes of persons or organisations.
5: For the purposes of subsection (3)﻿(a)
a: the applicant has notified the Director-General in writing that the person may grant consent (and the applicant has not withdrawn that permission); or
b: the applicant’s rights in respect of the information have been transferred to the person and the applicant or the person has notified the Director-General in writing of the transfer.
9: Section 81 amended (Principles of cost recovery)
In section 81(1) 83 81L
2: Consequential amendments and transitional provisions
Consequential amendments
10: Consequential amendments to principal Act
Amend the principal Act as set out in Schedule 1
11: Consequential amendments to other enactments
Amend the enactments specified in Schedule 2 2016-11-08 Hazardous Substances and New Organisms Act 1996 Medicines Act 1981 Transitional provisions
12: New Schedule 1 inserted
Insert the Schedule 1 set out in Schedule 3