Listable Chemical Product (Joint Health Products for Dogs and Horses) Standard 2007
Agricultural and Veterinary Chemicals Code
I, SUSSAN PENELOPE LEY, Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry, approve this standard under section 56D of the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.
Dated 27 September 2007
SUSSAN LEY
Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry
Contents
Part 1 Preliminary
1 Name of Standard 3
2 Commencement 3
3 Establishment of Standard 3
4 Purpose of Standard 3
5 Application of Standard 3
6 Definitions 3
Part 2 Requirements in relation to the listable chemical product
7 Formulation requirements for listable chemical product 5
8 Additional constituents in listable chemical products 5
9 Site of product manufacture 6
10 Package limits 6
11 Labels 7
Schedule 1 Label format 8
Part 1 Preliminary
1 Name of Standard
This Standard is the Listable Chemical Product (Joint Health Products for Dogs and Horses) Standard 2007.
2 Commencement
This Standard commences immediately after the commencement of the Agricultural and Veterinary Chemicals Code Amendment Regulations 2007 (No. 1).
3 Establishment of Standard
This Standard is established in accordance with section 56D of the Agricultural and Veterinary Chemicals Code.
Note The Agricultural and Veterinary Chemicals Code is set out in the Schedule to the Act.
4 Purpose of Standard
The purpose of this Standard is to set out requirements in relation to a chemical product or class of chemical products to which the standard applies, including the labelling and handling of the product or products.
5 Application of Standard
This Standard applies to the listable chemical product described in item 2 of the Listing Schedule Table.
Note The listable chemical product to which this Standard applies is a veterinary chemical product, the long term use of which may help improve joint health and function in dogs and horses.
6 Definitions
In this Standard:
Act means the Agricultural and Veterinary Chemicals Code Act 1994
active constituent in the listable chemical product means an active constituent mentioned in column 2 of item 2 of the Listing Schedule Table.
Listing Schedule Table means the table in Part 2 of Schedule 3B to the regulations.
Standard for the Uniform Scheduling of Drugs and Poisons has the same meaning as in the regulations.
Note The following terms are defined in the Act or the Code:
· active constituent (Code)
· APVMA (Code)
· chemical product (Code)
· constituent (Code)
· the Code (Act)
· the regulations (Act).
Part 2 Requirements in relation to the listable chemical product
7 Formulation requirements for listable chemical product
The listable chemical product must be formulated to provide:
(a) when used on dogs — at least 10 milligrams of the parent molecule contained in the salt of the active constituent in the listable chemical product for each kilogram of body weight of the dog each day up to a maximum of 100 milligrams for each kilogram of body weight each day; and
(b) when used on horses — at least 10 milligrams of the parent molecule contained in the salt of the active constituent in the listable chemical product for each kilogram of body weight of the horse each day up to a maximum of 50 milligrams for each kilogram of body weight each day.
8 Additional constituents in listable chemical products
(1) The listable chemical product may also contain 1 or more of the following constituents:
(a) vitamins, minerals (other than selenium) or amino acids that:
(i) are mentioned in Schedule 5 of the Standard for the Uniform Scheduling of Drugs and Poisons (the SUSDP); or
(ii) are not mentioned in a schedule other than Schedule 5 of the SUSDP;
(b) stockfood non‑active constituents:
(i) of the kind specified in the Veterinary Chemical Products (Excluded Stockfood Non‑active Constituents) Order; and
(ii) which are used in the product for the functions specified in that Order;
(c) non‑active constituents:
(i) specified in the publication entitled ‘Handbook of Pharmaceutical Excipients’ published by the British Pharmaceutical Society and the American Pharmaceutical Association; and
(ii) used in the product for the functions listed in that publication;
(d) natural food ingredients.
(2) If a constituent of the kind mentioned in subsection (1) (additional constituent) is included in the listable chemical product, the product must be labelled to include the following information:
(a) a heading containing the words ‘other ingredients’; and
(b) under that heading:
(i) the name of each additional constituent; and
(ii) the concentration of that constituent in the product.
(3) A claim about an additional constituent on a label for the listable chemical product must not state that the additional constituent is suitable for the purposes mentioned in paragraph 5 (2) (a), (b), (c) or (d) of the Code.
9 Site of product manufacture
(1) Each step in the manufacture of the listable chemical product must take place on premises that:
(a) if the premises are in Australia — are licensed by the APVMA for the purpose of carrying out the steps in the manufacture of the product; and
(b) if the premises are not in Australia — are premises that:
(i) in the opinion of the APVMA, are subject to and comply with standards consistent with the manufacturing principles; or
(ii) have been assessed by the APVMA as complying with the manufacturing principles.
(2) In this section:
manufacturing principles means the written principles to be observed in the manufacture of chemical products as set out in the Agricultural and Veterinary Chemical Instrument No. 1 (Manufacturing Principles) 2007 as in force from time to time.
step in the manufacture of the listable chemical product includes the formulating, testing, filling, packaging and labelling of the listable chemical product.
10 Package limits
(1) The listable chemical product, when packaged, must not:
(a) contain more than 2 kg of the parent molecule contained in the salt of the active constituent in the listable chemical product; and
(b) if in powdered form — weigh more than 5 kg; and
(c) if the product is a medicated stockfood — weigh more than 25 kg.
(2) The package limit specified in paragraph (1) (a) applies to:
(a) if there is 1 active constituent in the listable chemical product — the weight of 1 active constituent; or
(b) if there are 2 or more active constituents in the listable chemical product — the total weight of all active constituents in the listable chemical product.
Note 1 The term active constituent in the listable chemical product is defined in section 6.
Note 2 The requirements for containers for the supply of a registered listed chemical product are set out in regulation 23C of the regulations.
11 Labels
(1) The label on a container for the listable chemical product must comply with the label format set out in Schedule 1.
(2) Subject to subsection (3), the only claim about the listable chemical product that may be included on the label of a container for the product is ‘long term use may help improve joint health and function’, or words to that effect.
(3) If the listable chemical product also contains vitamins or minerals mentioned in paragraph 8 (1) (a), the label of a container for the product may contain a claim about the vitamins or minerals consisting only of the words ‘to supplement diets where levels may be low’, or words to that effect.
Schedule 1 Label format
(subsection 11 (1))
FRONT PANEL
[Insert S5 signal heading if applicable]
FOR ANIMAL TREATMENT ONLY
[PRODUCT NAME]
ACTIVE CONSTITUENT: [Insert the following information:
(a) the Australian approved name of each active constituent cited in Subdivision 3.2.1 of Part 3 of Schedule 3B to the regulations; and
(b) the concentration of each active constituent — use mg/Kg, g/Kg, or mg/capsule/tablet].
[For chondroitin sulfate or naturally derived glucosamine – state tissue of origin (eg marine exoskeleton, shark cartilage, bovine cartilage etc].
OTHER INGREDIENTS: [Insert the concentration and name of each additional constituent of the kind mentioned in section 8 of the Listable Chemical Product (Joint Health Products for Dogs and Horses) Standard 2007 — use mg/Kg, g/Kg, or mg/capsule/tablet].
Long term use may help improve joint health and function. [Or insert words to that effect]
Contents: [Insert net weight or number of tablets/capsules]
ANCILLARY PANEL
DIRECTIONS FOR USE
Not recommended for use in acute or infectious joint conditions. For a diagnosis to determine these conditions, or in the event of adverse experience (eg diarrhoea) or where response is unsatisfactory, consult your veterinarian. Use with caution in pregnant or lactating animals as safe use in these groups has not been established. Use with caution in animals with bleeding, liver or kidney disorders.
[Insert the following information:
(a) dosage instructions in accordance with section 7 of the Listable Chemical Product (Joint Health Products for Dogs and Horses) Standard 2007; and
(b) administration instructions consistent with the use information set out in column 3 of item 2 in the table in Part 2 of Schedule 3B to the regulations. Give dose in mg/Kg body weight followed by discrete dose per weight or weight range as applicable].
USER SAFETY INFORMATION: Avoid inhalation of dust.
FIRST AID: If poisoning occurs contact a doctor or Poisons Information Centre (phone 131126).
[Insert registered company name[1], phone number and address]
STORAGE: Store below 30 ºC (room temperature). Protect from moisture, heat and light. Keep container tightly closed.
APVMA Listed Product Number:
EXPIRY DATE: [Insert date – not to exceed 12 months from date of manufacture]
BATCH NUMBER: [Insert batch number]
[1] Or other legal entity
