Commonwealth Numbered Regulations Commonwealth Numbered Regulations
[1] Subregulation 3 (1), definition of Code
substitute
"Code has the same meaning as this Code" in section 3 of the Schedule to the Act.
[2] Subregulation 3 (1), after definition of CSIRO
insert
"current Poisons Standard" has the meaning given by subsection 52A (1) of the Therapeutic Goods Act 1989 .
[3] Subregulation 3 (1), after definition of immunobiological product
insert
"labelling standard" means a standard determined for regulation 18A.
[4] Subregulation 3 (1), definition of poison schedule classification
omit
Standard for the Uniform Scheduling of Drugs and Poisons.
insert
current Poisons Standard.
[5] Subregulation 3 (1), definition of Standard for the Uniform Scheduling of Drugs and Poisons
omit
[6] Subregulation 3 (1), at the foot
insert
Note Several other words and expressions used in these Regulations have the meaning given by section 3 of the Code in the Schedule to the Act. For example:
* active constituent
* agricultural chemical product
* approved label
* interested person
* label
* relevant particulars
* veterinary chemical product.
[7] After regulation 3B
insert
3C Definition of confidential commercial information -- section 3 of the Code
For paragraph (e) of the definition of confidential commercial information in section 3 of the Code, the following information is prescribed:
(a) the name of the applicant;
(b) the application number;
(c) the chemical product number;
(d) the name of each of the active constituents of the chemical product;
(e) a short description of the application and its purpose, including a description of the way in which the chemical product is intended to be used.
[8] Before regulation 8A
insert
Division 2.1 Granting or refusing approvals and registrations
Subdivision 2.1.1 Preliminary applications -- summaries of applications
[9] Regulation 8A
omit everything before paragraph (a) except the heading, insert
(1) This regulation applies to an application for approval of an active constituent for a proposed or existing chemical product that is a companion animal product.
(2) For subsection 11B (2) of the Code, the details are:
[10] Regulation 8B, heading
substitute
8B Summaries of applications for active constituents for chemical products that are not companion animal products
[11] Subregulation 8B (1)
substitute
(1) This regulation applies to an application for the approval of an active constituent for a proposed or existing chemical product that is not a companion animal product.
[12] Subregulation 8B (2)
omit
The details are:
insert
For subsection 11B (2) of the Code, the details are:
[13] Subregulation 8C (1)
substitute
(1) This regulation applies to an application for:
(a) registration of a chemical product that is a companion animal product; or
(b) approval of a label for a container for a chemical product that is a companion animal product.
[14] Subregulation 8C (2)
omit
The details are:
insert
For subsection 11B (2) of the Code, the details are:
[15] Regulation 8D, heading
substitute
8D Summaries of applications for chemical products that are not companion animal products or repacks
[16] Subregulation 8D (1)
substitute
(1) This regulation applies to an application for:
(a) registration of a chemical product that is not:
(i) a companion animal product; or
(ii) a chemical product mentioned in paragraph 8E (1) (a); or
(b) approval of a label for a container for a chemical product mentioned in paragraph (a).
[17] Subregulation 8D (2)
omit
The details are:
insert
For subsection 11B (2) of the Code, the details are:
[18] Regulation 8E, heading
substitute
8E Summaries of applications for registered chemical products with new brand names
[19] Subregulation 8E (1)
substitute
(1) This regulation applies to an application for:
(a) registration of any kind of chemical product that is:
(i) the same as a registered chemical product; and
(ii) intended to be marketed under a brand name that is different from the brand name used for the registered chemical product; or
(b) approval of a label for a container for a chemical product mentioned in paragraph (a).
[20] Subregulation 8E (2)
omit
The details are:
insert
For subsection 11B (2) of the Code, the details are:
[21] After regulation 8E
insert
Subdivision 2.1.2 Grant or refusal of applications
[22] Subregulation 9 (1)
omit
For the purposes of paragraphs 14 (3) (d) and 29 (1) (d) of the Code,
insert
For paragraph 14 (3) (d) of the Code,
[23] Subregulation 9 (1), at the foot
insert
Note For the application of this regulation in relation to applications for variations, see regulation 19A.
[24] Subregulation 11 (1)
omit
For the purposes of paragraphs 14 (3) (d) and 29 (1) (d) and subsection 34A (1) of the Code,
insert
For paragraph 14 (3) (d) of the Code,
[25] Paragraphs 11 (2) (a) and (e)
omit
Standard for the Uniform Scheduling of Drugs and Poisons;
insert
current Poisons Standard;
[26] Paragraphs 11 (2) (g), (h) and (j)
omit
[27] Regulations 11A, 12, 13 and 14
substitute
12 Labels to contain additional instructions
(1) For subparagraph 14 (3) (g) (x) of the Code, the following are prescribed matters:
(a) if the chemical product is a veterinary chemical product, the duration of any treatment using the product;
(b) any matter determined by the APVMA under subregulation (2).
(2) For paragraph 6 (2) (c) of the Act, the APVMA may determine that a label will contain instructions about a matter.
13 Assessment of use of active constituent as an undue hazard
For paragraph 14 (4) (e) of the Code, the method of analysis (if any) of the chemical composition of the active constituent concerned is a prescribed matter.
14 Assessment of use of chemical product as an undue hazard
For paragraph 14 (5) (i) of the Code, the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product is a prescribed matter.
[28] Before regulation 15
insert
Subdivision 2.1.3 Particulars for approvals, registrations and labelling
[29] Subregulation 15 (1)
omit everything before paragraph (a), insert
(1) For paragraph 19 (2) (a) of the Code, the following particulars are prescribed:
[30] Subregulation 15 (2)
substitute
(2) A particular mentioned in paragraphs (1) (c) to (j) is only prescribed for an active constituent approved in accordance with section 14A of the Code if the particular is readily available to the APVMA.
[31] Regulation 16
omit everything before paragraph (a) except the heading, insert
For paragraph 20 (2) (a) of the Code, the following particulars are prescribed:
[32] After regulation 16
insert
17 Particulars for label
(1) For paragraph 21 (2) (a) of the Code, the following particulars are prescribed:
(a) the appropriate signal words required by the current Poisons Standard;
(b) the name of the chemical product;
(c) the name of each active constituent of the product;
(d) the proportion of each active constituent of the product;
(e) the name of each constituent for the product that is:
(i) not an active constituent; and
(ii) classified as a poison in the current Poisons Standard;
(f) the proportion of each constituent referred to in paragraph (e);
(g) the name and address of the person who is primarily responsible for marketing the product;
(h) the net contents of the product;
(i) the distinguishing number of the label for the product (including a distinguishing number given to the label under paragraph 178 (2) (a) of the Code);
(j) particulars determined by the APVMA under subregulation (2).
Note The particulars prescribed in this regulation are a requirement prescribed by the regulations in relation to a label for paragraph 14 (3) (d) of the Code.
(2) For paragraph 6 (2) (c) of the Act, the APVMA may determine additional particulars to be placed on a label for a product.
[33] Regulation 18
substitute
Subdivision 2.1.4 Conditions of approval -- active constituents and chemical products
18 Containers for the supply of registered chemical products
(1) For paragraph 23 (2) (a) of the Code, the kind of container described in this regulation is prescribed.
(2) The container must:
(a) be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service; and
(b) have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions; and
(c) if it is intended to be opened more than once -- be able to be securely and readily closed and reclosed; and
(d) have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and
(e) enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot:
(i) harm any person; or
(ii) have an unintended effect that is harmful to the environment.
(3) Nothing in subregulation (2) is intended to affect the operation of any other law that applies in relation to containers for chemical products.
Subdivision 2.1.5 Labelling standard
18A Labelling standard
(1) The Chief Executive Officer may determine, by legislative instrument, any of the following requirements for a label for a container for a chemical product:
(a) the presentation of the label, including the size, colour, legibility, dimensions, layout and format of the label;
(b) the display of the label;
(c) the information contained on the label.
Note A label can contain information in addition to the information required by legislation.
(2) A legislative instrument for this provision is called a labelling standard.
Subdivision 2.1.6 Conditions of approval -- labels
18B Prescribed conditions for labels
(1) For paragraph 23A (1) (a) of the Code, the conditions in this subdivision are prescribed.
(2) For subsection 23A (3) of the Code, the conditions prescribed in this subdivision apply to a label for containers for all chemical products.
18C Label must be attached to containers for chemical products
The label must be attached to the container for the chemical product to which it relates before the supply of the product.
Note For supply , see section 3 of the Code.
18D Information on label
(1) Unless authorised by a permit, the label must state the following information:
(a) the relevant particulars for the label;
(b) the batch number of the chemical product;
(c) the expiry date of the chemical product (if applicable);
(d) the date of manufacture of the chemical product (if applicable).
Note 1 For relevant particulars , see section 3 of the Code.
Note 2 A label can contain information in addition to the information required by legislation.
(2) The label must not contain information that is contrary to the information mentioned in subregulation (1).
(3) The information mentioned in subregulation (1), on the label, must not be altered, defaced, obliterated, obscured or destroyed.
18E Labelling standards and requirements
The label must comply with the requirements of:
(a) if a labelling standard has been made by the Chief Executive Officer for regulation 18A -- the labelling standard; or
(b) if a labelling standard has not been made by the Chief Executive Officer for regulation 18A -- either:
(i) if the product is a veterinary chemical product -- the Veterinary Labelling Code made by the APVMA, as in force from time to time; or
(ii) if the product is an agricultural chemical product -- the Agricultural Labelling Code made by the APVMA, as in force from time to time.
Note The Veterinary Labelling Code and the Agricultural Labelling Code are available at http://www.apvma.gov.au .
18F Requirements for information on labels
(1) The label must not contain misleading or deceptive information about either:
(a) a relevant particular on the label; or
(b) the use, safety, environmental impact or efficacy of the chemical product to which the label relates.
(2) If the label is, or is required to be, attached to a container, information must not accompany or be placed on the container, including in the form of another label, if the information expressly or impliedly:
(a) negates or varies information required by subregulation 18D (1) to be stated on the label; or
(b) qualifies or minimises the substance or effect of the information required by subregulation 18D (1) to be stated on the label.
(3) To avoid doubt, the label must not contain instructions about the circumstances in which, or the purposes for which, the chemical product can be used, if those instructions are inconsistent with the instructions for use approved for the label by the APVMA.
18G Requirements about claims inconsistent with labels
(1) An interested person in relation to the label must not make any claim, or cause or permit any claim to be made, about:
(a) a registered chemical product; or
(b) a chemical product that contains a registered chemical product;
that is inconsistent with an instruction on the label for a container for the chemical product.
(2) Subregulation (1) does not apply to:
(a) a claim exempted by the APVMA from the operation of section 84 of the Code; or
(b) a claim made in a notice published under section 55 of the Code; or
(c) a claim permitted to be made under a law of the Commonwealth; or
(d) a claim about conduct the person is authorised to engage in by a permit issued by the APVMA.
18H Retention of label and information about label
(1) An interested person in relation to the label must:
(a) retain a copy of each form of the label that is attached to a container, or a series of containers, released for supply; and
(b) record either:
(i) if the form of the label states a sequential batch number of the chemical product -- the first batch number in the sequence for the form of label; or
(ii) if the form of the label does not state a sequential batch number of the chemical product -- each batch number for the form of label; and
(c) record the day on which the series of containers on which the form of the label is attached is first released for supply.
(2) The label and information mentioned in subregulation (1) must be retained:
(a) in a secure manner; and
(b) for a 5 year period commencing on the last day on which the chemical product is supplied in a container with the label attached.
(3) For paragraphs (1) (a) and (c), a container is released for supply on the day when the container is sent from a manufacturing or packaging facility for the purposes of distribution or sale.
18I Providing label and information about label to APVMA
(1) An interested person in relation to the label must, on a written request by the APVMA for:
(a) a copy of a form of the label mentioned in paragraph 18H (1) (a); and
(b) information about the label mentioned in paragraphs 18H (1) (b) and (c);
provide the label and information requested to the APVMA.
(2) If the request is for a copy of a form of a label, the copy must be accompanied by a declaration that the copy is of a form of label that has been attached to a container to which it relates.
(3) The label and information must be provided to the APVMA on the earlier of the following:
(a) within 10 days of the day on which the request for the label and information is received;
(b) on a day advised by the APVMA.
(4) The APVMA must not advise a date for paragraph (3) (b) unless:
(a) the APVMA believes it is necessary to receive the label or information before the end of the period mentioned in paragraph (3) (a) to prevent imminent risk to public health or to occupational health or safety; and
(b) the APVMA provides the reasons for the early date in the written request.
[34] Before regulation 19
insert
Subdivision 2.1.7 Notice of approval or registration
[35] Before subregulation 19 (1)
insert
(1A) For subsection 24 (2) of the Code, the information set out in this regulation is prescribed.
[36] Subregulation 19 (1)
omit everything before paragraph (a), insert
(1) If the notice is about the approval of an active constituent, the information is:
[37] Subregulation 19 (2)
omit everything before paragraph (b), insert
(2) If the notice is about the registration of a chemical product, the information is:
(a) the matters about the approved label recorded in the relevant APVMA file under paragraphs 21 (2) (c) and (d) of the Code;
[38] Subregulation 19 (3)
omit everything before paragraph (a), insert
(3) If the notice is about the approval of a label for a container for a chemical product, the information is:
[39] Paragraph 19 (3) (b)
substitute
(b) the matters about the approved label recorded in the relevant APVMA file under paragraphs 21 (2) (c) and (d) of the Code;
[40] After regulation 19
insert
Division 2.2 Granting or refusing applications for variation of relevant particulars, or conditions, of approvals or registration
Subdivision 2.2.1 Variation applications -- summaries of applications
[41] Regulation 19AA
substitute
19AA Summaries of applications for variation of approvals for active constituents for companion animal products
(1) This regulation applies to:
(a) an application for variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product; and
(b) the chemical product is a companion animal product.
(2) For subsection 28B (2) of the Code, the details are:
(a) the name of the applicant; and
(b) the application number; and
(c) the name of the active constituent; and
(d) the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and
(e) a short description of the application and its purpose, including the way in which the active constituent is intended to be used.
[42] Subregulation 19AB (1)
substitute
(1) This regulation applies to:
(a) an application for variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product; and
(b) the chemical product is not a companion animal product.
[43] Subregulation 19AB (2)
omit
The details are:
insert
For subsection 28B (2) of the Code, the details are:
[44] Subregulation 19AC (1)
substitute
(1) This regulation applies to an application for variation of the relevant particulars or conditions of:
(a) the registration of a chemical product that is a companion animal product; or
(b) the approval of a label for a container for a chemical product that is a companion animal product.
[45] Subregulation 19AC (2)
omit
The details are:
insert
For subsection 28B (2) of the Code, the details are:
[46] Subregulation 19AD (1)
substitute
(1) This regulation applies to an application for variation of the relevant particulars or conditions of:
(a) the registration of a chemical product that is not a companion animal product; or
(b) the approval of a label for a container for a chemical product that is not a companion animal product.
[47] Subregulation 19AD (2)
omit
The details are:
insert
For subsection 28B (2) of the Code, the details are:
[48] After regulation 19AD
insert
Subdivision 2.2.2 Grant or refusal of variation application
[49] Regulation 19A
substitute
19A Variation of relevant particulars or conditions of approval or registration
For paragraph 29 (1) (d) of the Code, the requirements are:
(a) the requirements for agricultural chemical products in regulation 9; and
(b) the requirements for a label for containers for a chemical product in regulation 11.
[50] Before regulation 20
insert
Division 2.3 Reconsideration of approval or registration
[51] Regulation 22
substitute
22 Requirements for continued approval of label
For paragraph 32 (1) (aa) and subsection 34 (5) of the Code, the requirements for the continued approval of a label are:
(a) that the instructions contained on the label, for the matters set out in paragraph 14 (3) (g) of the Code that the APVMA thinks are appropriate for reconsideration, are adequate; and
(b) that the particulars contained on the label for regulation 17 are adequate; and
(c) that the label is subject to appropriate conditions.
Note For conditions of approval of a label, see section 23A of the Code.
22AA Reconsideration by APVMA of approval of label
For subsection 34A (1) of the Code, the prescribed matters are:
(a) any matter prescribed by the regulations that is a requirement in relation to a constituent, product or label for paragraph 14 (3) (d) of the Code; and
(b) any matter prescribed by the regulations for subparagraph 14 (3) (g) (x) of the Code.
Note 1 See regulation 11 for requirements for paragraph 14 (3) (d) of the Code.
Note 2 See regulation 12 for matters for subparagraph 14 (3) (g) (x) of the Code.
[52] Before regulation 22A
insert
Division 2.4 Limits on use of information
[53] Before regulation 22B
insert
Division 2.5 Summaries of advice on applications
[54] Before regulation 23
insert
Division 2.6 Late applications
[55] After regulation 23A
insert
23AB Preparation of standards -- prescribed matters
(1) For subparagraph 56E (1) (f) (x) of the Code, the following are prescribed matters:
(a) if a label is for a container containing a veterinary chemical product, the duration of any treatment using the product;
(b) any matter determined by the APVMA under subregulation 12 (2).
Note Subregulation 12 (2) provides for the APVMA to determine, for paragraph 6 (2) (c) of the Act, that a label will contain instructions about a matter.
(2) For paragraph 56E (2) (i) of the Code, the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product is a prescribed matter.
[56] Subparagraph 24 (a) (iii)
substitute
(iii) the matters about the approved label recorded in the APVMA file for paragraphs 21 (2) (c) and (d) of the Code;
[57] Paragraph 25 (c)
substitute
(c) the matters about the approved label recorded in the APVMA file for paragraphs 21 (2) (c) and (d) of the Code.
[58] Paragraph 42 (3) (b)
omit
[59] Subregulation 71 (4), note 1
substitute
Note 1 The Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2010 sets out criteria for working out which fee applies under regulation 71 in a particular case.
[60] Schedule 6, Part 2, after item 13
insert
Applications to change relevant particular of an approval or registration |
|||
|
13A |
Application to change a relevant particular of an approval or registration where the relevant particular is set out in a legislative instrument made for section 26A of the Code |
2 months |
385 |