Commonwealth Consolidated Regulations

AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995

- made under the Agricultural and Veterinary Chemicals Code Act 1994

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Name of Regulations [see Note 1]  
   2.      Commencement [see Note 1]  
   3.      Interpretation  
   3A.     Meaning of reference active constituent  
   3B.     Meaning of reference chemical product  
   3C.     Definition of confidential commercial information -- section 3 of the Code  
   4.      Definition of date-controlled chemical product -- section 3 of the Code  
   5.      Definition of excluded organism -- section 3 of the Code  
   6.      Definition of protection period -- section 3 of the Code  
   7.      Definition of agricultural chemical product -- section 4 of the Code  
   8.      Definition of veterinary chemical product -- section 5 of the Code  

   PART 2--APPROVALS AND REGISTRATION

           Division 2.1--Granting or refusing approvals and registrations

              Subdivision 2.1.1--Preliminary applications -- summaries of applications

   8A.     Summaries of applications for active constituents for companion animal products  
   8B.     Summaries of applications for active constituents for chemical products that are not companion animal products  
   8C.     Summaries of applications for companion animal products  
   8D.     Summaries of applications for chemical products that are not companion animal products or repacks  
   8E.     Summaries of applications for registered chemical products with new brand names  

              Subdivision 2.1.2--Grant or refusal of applications

   9.      Certain agricultural products must contain dye or pigment  
   11.     Labels to contain certain information  
   12.     Labels to contain additional instructions  
   13.     Assessment of use of active constituent as an undue hazard  
   14.     Assessment of use of chemical product as an undue hazard  

              Subdivision 2.1.3--Particulars for approvals, registrations and labelling

   15.     Particulars of approved active constituents to be recorded  
   16.     Particulars of registered chemical products to be recorded  
   17.     Particulars for label  

              Subdivision 2.1.4--Conditions of approval -- active constituents and chemical products

   18.     Containers for the supply of registered chemical products  

              Subdivision 2.1.5--Labelling standard

   18A.    Labelling standard  

              Subdivision 2.1.6--Conditions of approval -- labels

   18B.    Prescribed conditions for labels  
   18C.    Label must be attached to containers for chemical products  
   18D.    Information on label  
   18E.    Labelling standards and requirements  
   18F.    Requirements for information on labels  
   18G.    Requirements about claims inconsistent with labels  
   18H.    Retention of label and information about label  
   18I.    Providing label and information about label to APVMA  

              Subdivision 2.1.7--Notice of approval or registration

   19.     Information to be given in notice to approved person  

           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

   19AA.   Summaries of applications for variation of approvals for active constituents for companion animal products  
   19AB.   Summaries of applications for variation for active constituents other than for companion animal products  
   19AC.   Summaries of applications for variation for companion animal products  
   19AD.   Summaries of applications for variation for chemical products other than companion animal products  
   19A.    Variation of relevant particulars or conditions of approval or registration  

           Division 2.3--Reconsideration of approval or registration

   20.     Continued approval of an active constituent  
   21.     Continued registration of a chemical product  
   22.     Requirements for continued approval of label  
   22AA.   Reconsideration by APVMA of approval of label  

           Division 2.4--Limits on use of information

   22A.    Prescribed uses (Code, s 34F (5))  

           Division 2.5--Summaries of advice on applications

   22B.    Summaries of advice on applications for active constituents  
   22C.    Summaries of advice on applications for chemical products  

           Division 2.6--Late applications

   23.     Late applications for renewal of registration of chemical product  

   PART 2A--LISTABLE CHEMICAL PRODUCTS

   23A.    Listing Schedule  
   23AB.   Preparation of standards -- prescribed matters  
   23B.    Particulars of registered listed chemical products to be recorded  
   23C.    Containers for the supply of registered listed chemical products  
   23D.    Information to be given in notice to approved person  
   23E.    Continued listed registration of chemical product  
   23F.    Late applications for renewal of listed registration of chemical product  

   PART 2B--RESERVED CHEMICAL PRODUCTS

   23G.    Reserved Schedule  
   23H.    Conditions for dealing with reserved chemical product -- containers for supply  
   23I.    Conditions for dealing with reserved chemical product -- labels  

   PART 3--COMPENSATION FOR PROVIDER OF CERTAIN INFORMATION IN RESPECT OF CONTINUED REGISTRATION OF CERTAIN CHEMICAL PRODUCTS

           Division 1--Notices

   24.     Protected registered information -- notice to primary applicant  
   25.     Protected registered information -- notice to secondary applicant  

           Division 2--Conduct of arbitration

   26.     Rules governing the conduct of an arbitration  
   27.     Notice of appointment of arbitrator  
   28.     Parties to give information to arbitrator  
   29.     Mediator to submit report  
   30.     Arbitrator to conduct a hearing  
   31.     Arbitrator to give the applicants notice of the hearing  
   32.     Arbitrator's powers if applicant does not attend the hearing  
   33.     Procedure at the hearing  
   34.     Representation at the hearing  
   35.     Arbitrator may require information etc  
   36.     Fair proportion of cost of providing protected registration information  
   37.     Arbitrator's costs  
   38.     Applicants' costs of arbitration  
   39.     Arbitrator exonerated from liability  

   PART 4--CONTROL OF CHEMICAL PRODUCTS

           Division 1--General

   40A.    Exemption of existing use active constituents  
   40.     Supply of substances for research etc for chemical products  
   41.     Supply etc of substances with constituents differing from registered particulars  
   42.     Prescribed standards for chemical products  
   43.     When statements about chemical products can be made or reported  
   44.     Record of manufacture or import of date-controlled chemical product  
   45.     Restricted chemical products  
   46.     Supply of chemical product -- batch number or record of supply  

           Division 2--Supply of hormonal growth promotants

   47.     Notice of intention to supply hormonal growth promotant  
   47A.    Notification number may be replaced or withdrawn  
   47AB.   Review of decision withdrawing assigned notification number  
   47B.    Notification number to be renewed annually  
   47C.    Hormonal growth promotant not to be supplied etc  
   48.     Supply of hormonal growth promotant -- purchaser's declaration  
   49.     Record of supply of hormonal growth promotant -- manufacturer and supplier  
   50.     Record of supply of hormonal growth promotant -- importer and supplier  
   51.     Record of supply of hormonal growth promotant -- other suppliers  
   52.     Record of supply of hormonal growth promotant -- general requirements  
   53.     Copy of records to be given to APVMA  
   54.     Copy of records etc to be kept  

   PART 5--ANALYSIS

   55.     Analysis of chemical products -- tests  
   56.     Analysis at an accredited laboratory  

   PART 6--PERMITS

   57.     Additional requirement for the issue of a permit  

   PART 7--MANUFACTURE OF CHEMICAL PRODUCTS

   58.     Coming into force of section 121 of the Code  
   59.     Manufacture of chemical products -- exempt products  
   59A.    Manufacture of chemical products -- exempt persons -- single step  
   59B.    Manufacture of chemical products -- exempt persons -- chemical product that ceases to be exempt  
   59C.    Manufacture of chemical products -- exempt persons -- legal personal representative etc of licence holder  
   59D.    Manufacture of chemical products -- exempt persons -- person that acquires business including transfer of licence  
   60.     Licence condition -- holder to give information about manufacture  
   61.     Licence conditions -- general  
   62.     Licence condition -- naming persons in control of production etc  

   PART 8--ENFORCEMENT

   63.     Method of securing samples  
   64.     Form of search warrant  

   PART 9--MISCELLANEOUS

   65.     Prescribed authorities that may require further information  
   66.     Disclosure of confidential commercial information about toxicity etc  
   67.     Disclosure of confidential commercial information about chemical products not yet registered etc  
   68.     Disclosure of confidential commercial information to international organisations  
   69.     Disclosure of confidential commercial information -- records  
   70.     Fees for applications  
   70A.    Fees in respect of existing use active constituents  
   71.     Modular assessment fee  
   71A.    Annual fees for continued registration of chemical product  
   72.     Remission of fees for applications  
   72A.    Fee for issue of licence  
   73.     Fees for copies and extracts  
   74.     Payment of fees  
   75.     Notification that application has been received  
   76.     Period within which APVMA is to determine application  
   77.     Modular assessment period  
   78.     Commencement of period for determining applications made under section 10 of the Code  
   78A.    Commencement of period for determining other applications  
   79.     Logo of the APVMA  
           SCHEDULE 1 Date-controlled agricultural chemical products
           SCHEDULE 2 Protected registration information -- allocated points
           SCHEDULE 3 Definition of agricultural chemical product
           SCHEDULE 3AA Definition of veterinary chemical product
           SCHEDULE 3A Prescribed uses (Code, s 34F (5))
           SCHEDULE 3B Listing Schedule
           SCHEDULE 3C Reserved Schedule
           SCHEDULE 4 Restricted chemical products
           SCHEDULE 5 AGVET Code -- Search warrant under subsection 133 (2)
           SCHEDULE 6 Applications -- fees and assessment periods
           SCHEDULE 7 Table of fees and periods for completion of modules, levels and types of assessments
           SCHEDULE 8 Logo of the Australian Pesticides and Veterinary Medicines Authority (APVMA)