Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 5) (Cth)

Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 5)¹

Statutory Rules 2004 No. 354²

I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Agricultural and Veterinary Chemicals Code Act 1994.

Dated 16 December 2004

P. M. JEFFERY

Governor-General

By His Excellency’s Command

RICHARD COLBECK

Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry

1. Name of Regulations

These Regulations are the Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 5).

1. Commencement

These Regulations commence on the commencement of Parts 1 and 2 of Schedule 2 to the US Free Trade Agreement Implementation Act 2004.

1. Amendment of Agricultural and Veterinary Chemicals Code Regulations 1995

Schedule 1 amends the Agricultural and Veterinary Chemicals Code Regulations 1995.

Schedule 1          Amendments

(regulation 3)

1. Subregulation 3 (1), after definition of Act

insert

active constituent number, for an active constituent for a proposed or existing chemical product for which approval is sought in an application mentioned in section 11B of the Code, means the number that the APVMA gives to the active constituent after the application is lodged.

application number, for an application mentioned in section 11B, 28B or 34G of the Code, means the number that the APVMA gives to the application after the application is lodged.

1. Subregulation 3 (1), after definition of British Pharmacopoeia (Veterinary)

insert

chemical product number, for a chemical product for which registration is sought in an application mentioned in section 11B of the Code, means the number that the APVMA gives to the chemical product after the application is lodged.

1. Subregulation 3 (1), after definition of purchaser declaration number

insert

reference active constituent has the meaning given by regulation 3A.

reference chemical product has the meaning given by regulation 3B.

1. After regulation 3

insert

3AMeaning of reference active constituent

For these Regulations, reference active constituent, for an application mentioned in section 11B or 28B of the Code (the primary application), means an active constituent that:

(a)is the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and

(b)is referred to in the primary application because information that is relevant to the active constituent is also relevant to the primary application.

3BMeaning of reference chemical product

For these Regulations, reference chemical product, for an application mentioned in section 11B or 28B of the Code (the primary application), means a chemical product that:

(a)is the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and

(b)is referred to in the primary application because information that is relevant to the chemical product is also relevant to the primary application.

1. Before regulation 9

insert

8ASummaries of applications for active constituents for companion animal products

For subsection 11B (2) of the Code, the details that must be included in the summary of the application if the application is for approval of an active constituent for a proposed or existing chemical product that is a companion animal product are:

(a)the name of the applicant; and

(b)the application number; and

(c)the name of the active constituent; and

(d)the active constituent number; and

(e)a short description of the application and its purpose, including the way in which the active constituent is intended to be used.

8BSummaries of applications for active constituents other than for companion animal products

(1)For subsection 11B (2) of the Code, this regulation sets out the details that must be included in the summary of the application if the application is for approval of an active constituent for a proposed or existing chemical product other than a companion animal product.

(2)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 active constituent number; and

(e)a short description of the application and its purpose, including the way in which the active constituent is intended to be used; and

(f)for any reference active constituent mentioned in the application:

(i)the name of the reference active constituent; and

(ii)if the active constituent is an approved active constituent — the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

(g)a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11 (1) (b) of the Code, including the details set out in subregulation (3); and

(h)any other information that the APVMA considers to be relevant to its decision on the application.

(3)For paragraph (2) (g), the details for each item of information are:

(a)the title shown on the item of information; and

(b)the name of the author, or of each of the authors, of the information; and

(c)the date shown on the item of information (if any); and

(d)if no date is shown on the item of information — the date when the preparation of the information was completed; and

(e)if the information was published:

(i)the date when it was published; and

(ii)the name of the publication in which it was published; and

(f)the reference number shown on the item of information; and

(g)the name and address of the authorising party for the information.

8CSummaries of applications for companion animal products

(1)For subsection 11B (2) of the Code, subregulation (2) sets out the details that must be included in the summary of the application if the application is 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.

(2)The details are:

(a)the name of the applicant; and

(b)the application number; and

(c)the chemical product number; and

(d)the name of each of the active constituents of the chemical product; and

(e)a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

8DSummaries of applications for chemical products other than companion animal products or repacks

(1)For subsection 11B (2) of the Code, this regulation sets out the details that must be included in the summary of the application if the application is for:

(a)registration of a chemical product other than:

(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 such a chemical product.

(2)The details are:

(a)the name of the applicant; and

(b)the application number; and

(c)the name of the chemical product; and

(d)the chemical product number; and

(e)the name of each of the active constituents of the chemical product; and

(f)a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

(g)for any reference active constituent mentioned in the application:

(i)the name of the reference active constituent; and

(ii)if the active constituent is an approved active constituent — the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

(h)for any reference chemical product mentioned in the application:

(i)the name of the reference chemical product; and

(ii)if the chemical product has been registered — the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

(i)a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11 (1) (b) of the Code, including the details set out in subregulation (3); and

(j)any other information that the APVMA considers to be relevant to its decision on the application.

(3)For paragraph (2) (i), the details for each item of information are:

(a)the title shown on the item of information; and

(b)the name of the author, or of each of the authors, of the information; and

(c)the date shown on the item of information (if any); and

(d)if no date is shown on the item of information — the date when the preparation of the information was completed; and

(e)if the information was published:

(i)the date when it was published; and

(ii)the name of the publication in which it was published; and

(f)the reference number shown on the item of information; and

(g)the name and address of the authorising party for the information.

8ESummaries of applications for registration of registered chemical products with new brand name

(1)For subsection 11B (2) of the Code, subregulation (2) sets out the details that must be included in the summary of the application if the application is for:

(a)registration of a chemical product (whether it is a companion animal product or another kind of chemical product) that:

(i)is the same as a registered chemical product; but

(ii)is 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 such a chemical product.

(2)The details are:

(a)the name of the applicant; and

(b)the application number; and

(c)the chemical product number; and

(d)the name of each of the active constituents of the chemical product; and

(e)a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

1. After regulation 19

insert

19AASummaries of applications for variation of approvals for active constituents for companion animal products

For subsection 28B (2) of the Code, the details that must be included in the summary of the application if the application is for variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product that is a companion animal product 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.

19ABSummaries of applications for variation for active constituents other than for companion animal products

(1)For subsection 28B (2) of the Code, this regulation sets out the details that must be included in the summary of the application if the application is for variation of the relevant particulars or conditions of the approval of an active constituent other than an active constituent for a chemical product that is a companion animal product.

(2)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; and

(f)for any reference active constituent mentioned in the application:

(i)the name of the reference active constituent; and

(ii)if the active constituent is an approved active constituent — the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

(g)for any reference chemical product mentioned in the application:

(i)the name of the reference chemical product; and

(ii)if the chemical product has been registered — the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

(h)a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11 (1) (b) of the Code, including the details set out in subregulation (3); and

(i)any other information that the APVMA considers to be relevant to its decision on the application.

(3)For paragraph (2) (h), the details for each item of information are:

(a)the title shown on the item of information; and

(b)the name of the author, or of each of the authors, of the information; and

(c)the date shown on the item of information (if any); and

(d)if no date is shown on the item of information — the date when the preparation of the information was completed; and

(e)if the information was published:

(i)the date when it was published; and

(ii)the name of the publication in which it was published; and

(f)the reference number shown on the item of information; and

(g)the name and address of the authorising party for the information.

19ACSummaries of applications for variation for companion animal products

(1)For subsection 28B (2) of the Code, subregulation (2) sets out the details that must be included in the summary of the application if the application is 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.

(2)The details are:

(a)the name of the applicant; and

(b)the application number; and

(c)the name of the chemical product; and

(d)if the application is in relation to the registration of a chemical product — the distinguishing number that the APVMA gave to the product when it decided to register the product; and

(e)the name of each of the active constituents of the chemical product; and

(f)a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

19ADSummaries of applications for variation for chemical products other than companion animal products

(1)For subsection 28B (2) of the Code, this regulation sets out the details that must be included in the summary of the application if the application is for variation of the relevant particulars or conditions of:

(a)the registration of a chemical product other than a companion animal product; or

(b)the approval of a label for a container for a chemical product other than a companion animal product.

(2)The details are:

(a)the name of the applicant; and

(b)the application number; and

(c)the name of the chemical product; and

(d)if the application is in relation to the registration of a chemical product — the distinguishing number that the APVMA gave to the product when it decided to register the product; and

(e)the name of each of the active constituents of the chemical product; and

(f)a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

(g)for any reference active constituent mentioned in the application:

(i)the name of the reference active constituent; and

(ii)if the active constituent is an approved active constituent — the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

(h)for any reference chemical product mentioned in the application:

(i)the name of the reference chemical product; and

(ii)if the chemical product has been registered — the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

(i)a short description of each item of information contained in, or accompanying, the application in compliance with paragraph 11 (1) (b) of the Code, including the details set out in subregulation (3); and

(j)any other information that the APVMA considers to be relevant to its decision on the application.

(3)For paragraph (2) (i), the details for each item of information are:

(a)the title shown on the item of information; and

(b)the name of the author, or of each of the authors, of the information; and

(c)the date shown on the item of information (if any); and

(d)if no date is shown on the item of information — the date when the preparation of the information was completed; and

(e)if the information was published:

(i)the date when it was published; and

(ii)the name of the publication in which it was published; and

(f)the reference number shown on the item of information; and

(g)the name and address of the authorising party for the information.

1. After regulation 22

insert

22ASummaries of advice on applications for active constituents

(1)For paragraph 34G (3) (b) of the Code, this regulation sets out the matters that must be included in the summary of the advice if the advice was for an application for:

(a)approval of an active constituent for a proposed or existing chemical product; or

(b)variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product.

(2)The matters 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; and

(f)brief details about the APVMA’s decision to grant the approval; and

(g)a summary of the advice given by the person, body or Government that the APVMA consulted, including:

(i)the kind of information given to the APVMA with the advice; and

(ii)any advice given in relation to any trials or related matters mentioned in the application; and

(iii)a summary of the results from any trials mentioned in the advice as relevant; and

(iv)the conclusions included in the advice; and

(h)a list of the items of information that the person, body or Government considered relevant to giving the advice, including the details set out in subregulation (3); and

(i)any other information given with the advice that the APVMA considers was relevant to its decision on the application.

(3)For paragraph (2) (h), the details for each item of information are:

(a)the data number given to the information by the APVMA; and

(b)the title shown on the item of information; and

(c)the name of the author, or of each of the authors, of the information; and

(d)if a date is shown on the item of information — the date shown; and

(e)if no date is shown on the item of information — the date when the preparation of the information was completed; and

(f)if the information was published:

(i)the date when it was published; and

(ii)the name of the publication in which it was published; and

(g)the reference number shown on the item of information; and

(h)the name and address of the authorising party for the information.

22BSummaries of advice on applications for chemical products

(1)For paragraph 34G (3) (b) of the Code, this regulation sets out the matters that must be included in the summary of the advice if the advice was for an application for:

(a)registration of a chemical product; or

(b)variation of the relevant particulars or conditions of:

(i)the registration of a chemical product; or

(ii)the approval of a label for a container for a chemical product.

(2)The matters are:

(a)the name of the applicant; and

(b)the application number; and

(c)the name of the chemical product; and

(d)if the application was for registration of a chemical product — the distinguishing number that the APVMA gave to the product when it decided to register the product; and

(e)the name of the active constituents of the chemical product; and

(f)a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

(g)brief details about the APVMA’s decision to grant the application; and

(h)a summary of the advice given by the person, body or Government that the APVMA consulted, including:

(i)the kind of information given; and

(ii)any advice given in relation to any trials or related matters mentioned in the application; and

(iii)a summary of the results from any trials mentioned in the advice as relevant; and

(iv)the conclusions included in the advice; and

(i)a list of the items of information that the person, body or Government considered relevant to giving the advice, including the details set out in subregulation (3); and

(j)any other information given with the advice that the APVMA considers was relevant to its decision on the application.

(3)For paragraph (2) (i), the details for each item of information are:

(a)the data number given to the information by the APVMA; and

(b)the title shown on the item of information; and

(c)the name of the author, or of each of the authors, of the information; and

(d)if a date is shown on the item of information — the date shown; and

(e)if no date is shown on the item of information — the date when the preparation of the information was completed; and

(f)if the information was published:

(i)the date when it was published; and

(ii)the name of the publication in which it was published; and

(g)the reference number shown on the item of information; and

(h)the name and address of the authorising party for the information.

Notes

1. These Regulations amend Statutory Rules 1995 No. 27, as amended by 1995 Nos. 54, 137 and 187; 1996 Nos. 83, 111, 162 and 216; 1997 No. 264; 1999 Nos. 215 and 247; 2002 Nos. 60 and 207; 2003 No. 8; 2004 Nos. 224, 225, 251 and 353.

1. Notified in the Commonwealth of Australia Gazette on 23 December 2004.