Agricultural and Veterinary Chemicals Code Regulations 1995

1

The active constituent must be manufactured in accordance with the composition and purity entered for the active constituent in the Record in accordance with paragraph 15(1)(d)

2

The active constituent must be manufactured by the manufacturer whose name is entered for the active constituent in the Record in accordance with paragraph 15(1)(e)

3

The active constituent must be manufactured at a site of manufacture entered for the active constituent in the Record in accordance with paragraph 15(1)(f)

4

The identifying information for the holder of the approval, and the nominated agent (if any), of the active constituent must be the identifying information for the holder and nominated agent (if any) entered for the active constituent in the Record

1

The chemical product must contain each of the constituents entered for the chemical product in the Register in accordance with paragraph 16(b)

2

The chemical product must be manufactured:

(a) in accordance with the particulars entered for the chemical product in the Register in accordance with paragraphs 16(b), (c), (d) and (da); and

(b) by a manufacturer whose name is entered for the chemical product in the Register in accordance with paragraph 16(g); and

(c) at a site of manufacture entered for the chemical product in the Register in accordance with paragraph 16(h)

3

A chemical product manufactured in Australia must not be supplied unless the APVMA has determined it is satisfied that each holder of a licence to carry out steps in the manufacture of the product is complying with the following conditions of the licence:

(a) any conditions imposed on the licence under subsections 126(1) and (2) of the Code;

(b) the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition;

(c) any of the conditions mentioned in subregulations 61(3) to (7A) to which the licence is subject

4

A chemical product manufactured outside Australia must not be supplied unless:

(a) the holder of the registration of the product has, on request by the APVMA, given the APVMA, or arranged for the manufacturer of the product to give the APVMA, evidence that each step in the manufacture of the product complies with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code (an overseas GMP compliance assessment); and

(b) the APVMA has assessed the overseas GMP compliance assessment and is satisfied that each step in the manufacture of the product complies with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code

5

The formulation type of the chemical product as supplied must be the formulation type entered for the chemical product in the Register in accordance with paragraph 16(da)

6

The net contents for the chemical product as supplied must be the net contents entered for the chemical product in the Register in accordance with paragraph 16(db)

7

The identifying information for the holder of the registration, and the nominated agent (if any), for the chemical product as supplied must be the identifying information for the holder and nominated agent (if any) entered for the chemical product in the Register