1

A variation of either or both of the following particulars:

but only if, under the varied particulars:

(a)     the manufacturer is the holder of a valid licence under Part 8 of the Code that authorises carrying out a step in the manufacture of the chemical product at premises at the site; or

(b)     the manufacturer is an exempt person as mentioned in paragraph 121(4)(a) of the Code in relation to the manufacture of the chemical product

any registration of a chemical product other than a chemical product that is prescribed under subregulation 59(1)

2

A variation of either or both of the following particulars:

(a)       the name of a manufacturer of a chemical product outside Australia;

(b)       the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts secondary steps of manufacture (excluding the step of a biological assay for an immunobiological product) in relation to the chemical product, but only if, under the varied particulars:

(i)     the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code

a registration of a chemical product, other than a chemical product that is prescribed under subregulation 59(1)

3

A variation of either or both of the following particulars:

(a)      the name of a manufacturer of a  chemical product outside Australia;

(b)      the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts primary steps of manufacture in relation to the chemical product, but only if, under the varied particulars:

(i)       at the time of the holder’s application, the site of manufacture is entered in the Register as a site for another chemical product of the holder, and the manufacturer conducts the same steps of manufacture in relation to the other chemical product; and

(ii)     the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code

a registration of a chemical product, other than

4

A variation of one or more constituents of a chemical product if:

(a) the constituent (the original constituent) is replaced with another constituent (the replacement constituent); and

(b) the original constituent is not an active constituent of the product; and

(c) the replacement constituent will not be an active constituent of the product; and

(d) the original and replacement constituents have the same purpose in the product; and

(e) the original and replacement constituents differ only in solvates or hydrates; and

(f) the original and replacement constituents have the same:

(i) pH; and

(ii) dissolution profile; and

(iii) hydrophilic or hydrophobic behaviour; and

(iv) hygroscopic behaviour; and

(g) neither the original nor replacement constituent are a nanomaterial; and

(h) in the case of the original and replacement constituents being a straight or branched unsaturated hydrocarbon—the change in the length of the hydrocarbon chain is not more than 33% of the length of the original constituent’s hydrocarbon chain; and

(i) the replacement constituent does not introduce material of human or animal origin into the product; and

(j) the variation does not require variation to the signal words required by the current Poisons Standard to be on the label of the product; and

(k) in the case of a product that is a molluscicide in the form of a bait or a product applied to seeds to be stored before planting or sowing—the variation does not change the colour of the product; and

(l) the variation does not require the formulation type entered in the Register for the product to be varied; and

(m) in the case of a product that has 9 or more constituents entered in the Register for the product—the variation is to no more than 25% of the number of constituents entered in the Register for the product; and

(n) in the case of a product that has less than 9 constituents entered in the Register for the product—the variation is to one or 2 of the constituents entered in the Register for the product

a registration of a chemical product, other than a chemical product that is:

(a) an antibiotic product; or

(b) an immunobiological product; or

(c) a product that is administered through direct injection into an animal

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

exp = expires/expired or ceases/ceased to have

reloc = relocated

effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

commenced or to be commenced

F2020L01027

18 August 2020

19 August 2020

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Section 4…………….

Section 5…………….

F2020L01027

F2020L01027