Agricultural and Veterinary Chemicals Code (Extension of Protection Periods and Limitation Periods) Order 2022
1Agricultural and Veterinary Chemicals Code (Extension of Protection Periods and Limitation Periods) Order 2022
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Agricultural and Veterinary Chemicals Code (Extension of Protection Periods and Limitation Periods) Order 2022
I, David Littleproud, Minister for Agriculture and Northern Australia, make the following order.
Dated 07/02/2022
David Littleproud
Minister for Agriculture and Northern Australia
Contents
Part 1—Preliminary
1 Name
2 Commencement
3 Authority
Part 2—Extension of protection periods and limitation periods
Division 1—Extension of protection periods
4 Extension of protection period—approved active constituents
5 Extension of protection period—registered agricultural chemical product
6 Extension of protection period—registered veterinary chemical product
7 Ending extensions of protection periods
Division 2—Extension of limitation periods
Subdivision A—Approved active constituents
8 Extension of initial limitation period
9 Extension of limitation period for making of applications at least 3 years before end of limitation period
Subdivision B—Registered agricultural chemical products
10 Extension of initial limitation period
11 Extension of limitation period for making of applications at least 3 years before end of limitation period
12 Period of extension
Subdivision C—Registered veterinary chemical products
13 Extension of initial limitation period
14 Extension of limitation period for making of applications at least 3 years before end of limitation period
Subdivision D—Ending extensions of limitation periods
15 Ending extensions of limitation periods
Part 3—Use tables
Division 1—Active constituents
16 Kind of use of an active constituent
Division 2—Agricultural chemical products
17 Kind of use of an agricultural chemical product
Division 3—Veterinary chemical products
18 Kind of use of a veterinary chemical product
Part 4—Application provisions
19 Application provisions—protection periods
20 Application provisions—limitation periods
Part 1—Preliminary
1 Name
This instrument is the Agricultural and Veterinary Chemicals Code (Extension of Protection Periods and Limitation Periods) Order 2022.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument At the same time as Part 3 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021 commences. 7 March 2022
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under the Agricultural and Veterinary Chemicals Code Act 1994.
Note: Section 7 of that Act permits the Minister to make orders with respect to most matters that may be dealt with by regulations under section 6 of that Act.
Part 2—Extension of protection periods and limitation periods
Division 1—Extension of protection periods
4 Extension of protection period—approved active constituents
(1) This section deals with extending the protection period in relation to protected information that is information or results that relate to an active constituent that has been approved.
(2) For the purposes of paragraph 34KA(3)(a) of the Code, the provisions are the following:
(a) subsection 26B(1) of the Code;
(b) subsection 27(1) or (2) of the Code.
(3) For the purposes of paragraph 34KA(3)(b) of the Code, the application must be seeking to vary instructions for use of the active constituent to add a use (the new use) of a kind (if any) covered by Division 1 of Part 3 of this order.
(4) Subject to subsection (5), the protection period in relation to the protected information referred to in subsection (1) is extended if the APVMA varies those instructions for use to add the new use.
(5) The protection period in relation to the protected information referred to in subsection (1) is not extended if the total length of all previous extensions of that protection period is 5 years.
5 Extension of protection period—registered agricultural chemical product
(1) This section deals with extending the protection period in relation to protected information that is information or results that relate to an agricultural chemical product that has been registered.
(2) For the purposes of paragraph 34KA(3)(a) of the Code, the provisions are the following:
(a) subsection 26B(1) of the Code;
(b) subsection 27(1) or (2) of the Code.
(3) For the purposes of paragraph 34KA(3)(b) of the Code, the application must be seeking to vary instructions for use of the agricultural chemical product to add a use (the new use) of a kind covered by Division 2 of Part 3 of this order.
(4) Subject to subsection (5), the protection period in relation to the protected information referred to in subsection (1) is extended if the APVMA varies those instructions for use to add the new use.
Note: See subsection (6) for the period of the extension.
(5) The protection period in relation to the protected information referred to in subsection (1) is not extended if the total length of all previous extensions of that protection period is 5 years.
Period of extension
(6) Subject to subsection (7), if a protection period in relation to protected information is extended under this section, the period of extension is as follows:
(a) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(2)—6 months;
(b) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(3)—12 months;
(c) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(4)—18 months;
(d) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(5)—6 months;
(e) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(6)—6 months.
Overall extension limit
(7) If the period of extension of a protection period in relation to protected information that would otherwise apply under subsection (6) would result in the total length of all extensions of the protection period in relation to that information being more than 5 years, then the period of extension is the remainder of that 5‑year period.
6 Extension of protection period—registered veterinary chemical product
(1) This section deals with extending the protection period in relation to protected information that is information or results that relate to a veterinary chemical product that has been registered.
(2) For the purposes of paragraph 34KA(3)(a) of the Code, the provisions are the following:
(a) subsection 26B(1) of the Code;
(b) subsection 27(1) or (2) of the Code.
(3) For the purposes of paragraph 34KA(3)(b) of the Code, the application must be seeking to vary instructions for use of the veterinary chemical product to add a use (the new use) of a kind (if any) covered by Division 3 of Part 3 of this order.
(4) Subject to subsection (5), the protection period in relation to the protected information referred to in subsection (1) is extended if the APVMA varies those instructions for use to add the new use.
(5) The protection period in relation to the protected information referred to in subsection (1) is not extended if the total length of all previous extensions of that protection period is 5 years.
7 Ending extensions of protection periods
(1) The APVMA must end an extension of a protection period in relation to protected information if:
(a) before the end of the extension and as a result of a notice lodged under subsection 26AB(1) of the Code or of an application made under subsection 26B(1) or 27(1) or (2) of the Code, the APVMA varies the instructions for use of the active constituent, agricultural chemical product or veterinary chemical product to remove the use that led to the extension; and
(b) the APVMA is satisfied in all the circumstances that it is appropriate to end the extension.
(2) Before ending the extension, the APVMA must give written notice to the holder that it proposes to end the extension. The notice must invite written submissions from the holder within 28 days or such further period as is specified in the notice.
(3) The APVMA must have regard to any written submissions from the holder that are made within the period covered by subsection (2).
(4) If the APVMA ends the extension, the APVMA must give notice of that ending to the holder. The notice must specify the day on which the extension ends (which must not be earlier than the day the notice is given).
(5) If the APVMA decides not to end the extension, the APVMA must give notice of that decision to the holder.
(6) For the purposes of paragraph 167(1)(y) of the Code, a decision of the APVMA under subsection (1) of this section is prescribed.
Division 2—Extension of limitation periods
Subdivision A—Approved active constituents
8 Extension of initial limitation period
For the purposes of paragraph 34MA(1)(a) of the Code, the limitation period for information covered by item 1 of the table in subsection 34M(1) of the Code is extended if:
(a) the information includes instructions for use of the active constituent referred to in that item; and
(b) that use is of a kind (if any) covered by Division 1 of Part 3 of this order.
9 Extension of limitation period for making of applications at least 3 years before end of limitation period
(1) This section deals with extending the limitation period for information covered by item 1 of the table in subsection 34M(1) of the Code.
(2) For the purposes of paragraph 34MA(3)(a) of the Code, the provisions are the following:
(a) subsection 26B(1) of the Code;
(b) subsection 27(1) or (2) of the Code.
(3) For the purposes of paragraph 34MA(3)(b) of the Code, the application must be seeking to vary instructions for use of the active constituent to add a use (the new use) of a kind (if any) covered by Division 1 of Part 3 of this order.
(4) Subject to subsection (5), the limitation period for the information referred to in subsection (1) is extended if the APVMA varies those instructions for use to add the new use.
(5) The limitation period for the information referred to in subsection (1) is not extended if the total length of all previous extensions of that limitation period is 5 years.
Subdivision B—Registered agricultural chemical products
10 Extension of initial limitation period
(1) For the purposes of paragraph 34MA(1)(a) of the Code, the limitation period for information covered by item 2 of the table in subsection 34M(1) of the Code is extended if:
(a) the chemical product referred to in that item is an agricultural chemical product; and
(b) the information includes instructions for use of that agricultural chemical product; and
(c) that use is of a kind covered by Division 2 of Part 3 of this order.
Note: See section 12 for the period of the extension.
(2) For the purposes of paragraph 34MA(1)(a) of the Code, the limitation period for information covered by item 3 of the table in subsection 34M(1) of the Code is extended if:
(a) that information includes instructions for use of the agricultural chemical product referred to in that item; and
(b) that use is of a kind covered by Division 2 of Part 3 of this order.
Note: See section 12 for the period of the extension.
11 Extension of limitation period for making of applications at least 3 years before end of limitation period
(1) This section deals with extending the limitation period for information covered by item 2 or 3 of the table in subsection 34M(1) of the Code.
(2) For the purposes of paragraph 34MA(3)(a) of the Code, the provisions are the following:
(a) subsection 26B(1) of the Code;
(b) subsection 27(1) or (2) of the Code.
(3) For the purposes of paragraph 34MA(3)(b) of the Code, the application must be seeking to:
(a) in the case of a limitation period for information covered by item 2 of the table in subsection 34M(1) of the Code where the chemical product referred to in that item is an agricultural chemical product—vary instructions for use of the agricultural chemical product to add a use (the new use) of a kind covered by Division 2 of Part 3 of this order; or
(b) in the case of a limitation period for information covered by item 3 of the table in subsection 34M(1) of the Code—vary instructions for use of the agricultural chemical product referred to in that item to add a use (the new use) of a kind covered by Division 2 of Part 3 of this order.
(4) Subject to subsection (5), the limitation period for the information referred to in subsection (1) is extended if the APVMA varies those instructions for use to add the new use.
Note: See section 12 for the period of the extension.
(5) The limitation period for the information referred to in subsection (1) is not extended if the total length of all previous extensions of that limitation period is 5 years.
12 Period of extension
(1) Subject to this section, if a limitation period for information is extended under this Subdivision, the period of extension is as follows:
(a) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(2)—6 months;
(b) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(3)—12 months;
(c) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(4)—18 months;
(d) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(5)—6 months;
(e) for each use of the agricultural chemical product concerned to which the extension relates that is covered by subsection 17(6)—6 months.
Overall extension limit
(2) If the period of extension of a limitation period for information that would otherwise apply under subsection (1) would result in the total length of all extensions of the limitation period for that information being more than 5 years, then the period of extension is the remainder of that 5‑year period.
Subdivision C—Registered veterinary chemical products
13 Extension of initial limitation period
(1) For the purposes of paragraph 34MA(1)(a) of the Code, the limitation period for information covered by item 2 of the table in subsection 34M(1) of the Code is extended if:
(a) the chemical product referred to in that item is a veterinary chemical product; and
(b) the information includes instructions for use of that veterinary chemical product; and
(c) that use is of a kind (if any) covered by Division 3 of Part 3 of this order.
(2) For the purposes of paragraph 34MA(1)(a) of the Code, the limitation period for information covered by item 4 of the table in subsection 34M(1) of the Code is extended if:
(a) that information includes instructions for use of the veterinary chemical product referred to in that item; and
(b) that use is of a kind (if any) covered by Division 3 of Part 3 of this order.
14 Extension of limitation period for making of applications at least 3 years before end of limitation period
(1) This section deals with extending the limitation period for information covered by item 2 or 4 of the table in subsection 34M(1) of the Code.
(2) For the purposes of paragraph 34MA(3)(a) of the Code, the provisions are the following:
(a) subsection 26B(1) of the Code;
(b) subsection 27(1) or (2) of the Code.
(3) For the purposes of paragraph 34MA(3)(b) of the Code, the application must be seeking to:
(a) in the case of a limitation period for information covered by item 2 of the table in subsection 34M(1) of the Code where the chemical product referred to in that item is a veterinary chemical product—vary instructions for use of the veterinary chemical product to add a use (the new use) of a kind (if any) covered by Division 3 of Part 3 of this order; or
(b) in the case of a limitation period for information covered by item 4 of the table in subsection 34M(1) of the Code—vary instructions for use of the veterinary chemical product referred to in that item to add a use (the new use) of a kind (if any) covered by Division 3 of Part 3 of this order.
(4) Subject to subsection (5), the limitation period for the information referred to in subsection (1) is extended if the APVMA varies those instructions for use to add the new use.
(5) The limitation period for the information referred to in subsection (1) is not extended if the total length of all previous extensions of that limitation period is 5 years.
Subdivision D—Ending extensions of limitation periods
15 Ending extensions of limitation periods
(1) The APVMA must end an extension of a limitation period for information covered by item 1, 2, 3 or 4 of the table in subsection 34M(1) of the Code if:
(a) before the end of the extension and as a result of a notice lodged under subsection 26AB(1) of the Code or of an application made under subsection 26B(1) or 27(1) or (2) of the Code, the APVMA varies the instructions for use of the active constituent, agricultural chemical product or veterinary chemical product to remove the use that led to the extension; and
(b) the APVMA is satisfied in all the circumstances that it is appropriate to end the extension.
(2) Before ending the extension, the APVMA must give written notice to the holder that it proposes to end the extension. The notice must invite written submissions from the holder within 28 days, or within such further period as is specified in the notice.
(3) The APVMA must have regard to any written submissions from the holder that are made within the period covered by subsection (2).
(4) If the APVMA ends the extension, the APVMA must give notice of that ending to the holder. The notice must specify the day on which the extension ends (which must not be earlier than the day the notice is given).
(5) If the APVMA decides not to end the extension, the APVMA must give notice of that decision to the holder.
(6) For the purposes of paragraph 167(1)(y) of the Code, a decision of the APVMA under subsection (1) of this section is prescribed.
Part 3—Use tables
Division 1—Active constituents
16 Kind of use of an active constituent
For the purposes of sections 4, 8 and 9, there are nil kinds of use of an active constituent.
Division 2—Agricultural chemical products
17 Kind of use of an agricultural chemical product
(1) For the purposes of sections 5, 10 and 11, the kind of use of an agricultural chemical product is one or more of the following:
(a) use of the product on a thing mentioned in an item of the table in subsection (2), (3) or (4);
(b) use of the product on a thing mentioned in column 1 of an item of the table in subsection (5) to treat a pest mentioned in column 2 of that item;
(c) use of the product on a thing mentioned in column 1 of an item of the table in subsection (6) to modify the physiology of the thing in a way mentioned in column 2 of that item.
Uses on things—6‑month extension
(2) The following table has effect:
Uses with a 6‑month extension
Item Thing
1 Berries and other small fruits
2 Brassica (cole or cabbage) vegetables, head cabbages, flowerhead cabbages
3 Bulb vegetables
4 Citrus fruits
5 Grass for sugar production
6 Legume vegetables
7 Pome fruits
8 Pulses
9 Seed for beverages and sweets
10 Stone fruits
Uses on things—12‑month extension
(3) The following table has effect:
Uses with a 12‑month extension
Item Thing
1 Assorted tropical and sub‑tropical fruits—inedible peel
282 Tropical and sub‑tropical fruits—inedible peel banana spotting bug
283 Tropical and sub‑tropical fruits—inedible peel spotting bug
284 Tropical fruit spotting bug
285 Tropical fruit—inedible peel scale
286 Truffle apple weevil
287 Truffle broadleaf weeds
288 Truffle grass weeds
289 Truffle slugs
290 Truffle snails
291 Wheat feathertop rhodes grass
292 Wildflowers borer
293 Zucchini two spotted (spider) mite
Uses on things to modify the physiology of the thing—6‑month extension
(6) The following table has effect:
Uses with a 6‑month extension
Item Column 1 Thing Column 2 Modification of the physiology of the thing
1 Linseed desiccation
2 Rice crop lodging
3 Rice reduce lodging
4 Safflower desiccation
5 Sunflower desiccation
6 Teff crop lodging
Division 3—Veterinary chemical products
18 Kind of use of a veterinary chemical product
For the purposes of sections 6, 13 and 14, there are nil kinds of use of a veterinary chemical product.
Part 4—Application provisions
19 Application provisions—protection periods
(1) Subsection 5(1) applies in relation to a protection period beginning before, on or after the commencement of this section.
(2) Subsection 5(2) applies in relation to an application made on or after the commencement of this section.
20 Application provisions—limitation periods
(1) Section 10 applies in relation to an application made under section 10 of the Code on or after the commencement of this section.
(2) Subsection 11(1) applies in relation to a limitation period beginning before, on or after the commencement of this section.
(3) Subsection 11(2) applies in relation to an application made on or after the commencement of this section.
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