Commonwealth Consolidated Regulations

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AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 

- made under the Agricultural and Veterinary Chemicals Code Act 1994

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

           Division 1.1A--Name and commencement

   1.      Name of Regulations  

           Division 1.1B--Orders

   2.      Orders  

           Division 1.1--Definitions

   3.      Interpretation  
   3AA.    Definition of minor use  
   3A.     Meaning of reference active constituent  
   3B.     Meaning of reference chemical product  
   3BA.    Definition of timeshift application  
   3C.     Definition of confidential commercial information-- section 3 of the Code  
   4.      Definition of date - controlled chemical product-- section 3 of the Code  
   5A.     Meaning of lodged  
   7.      Definition of agricultural chemical product-- section 4 of the Code  
   8.      Definition of veterinary chemical product-- section 5 of the Code  
   8AA.    Safety criteria--active constituents  
   8AB.    Safety criteria--chemical products  
   8AD.    Trade criteria  
   8AE.    Labelling criteria  
   8AF.    Standards made by APVMA  

           Division 1.2--General provisions about applications

   8AFA.   Application requirements--chemical product registration renewal applications  
   8AG.    Application requirements--timeshift applications  
   8AH.    Application requirements--copies of applications  
   8AHAA.  When other information may be taken into account in determining applications  

           Division 1.3--General provisions about notices

   8AHA.   Published notice of approvals of labels and variations of relevant particulars or conditions of approvals  
   8AK.    Information to be given in notice to holder  
   8AL.    Information to be given on refusal of application to vary prescribed relevant particular  
   8AM.    Publication requirements--approvals and variations of approvals of active constituents  
   8AN.    Publication requirements--registrations, variations of registrations and approval of labels  
   8AO.    Matters for notice following preliminary assessment  
   8AP.    Matters for notice--applications for technical assessments etc.  
   8AQ.    Matters for notice in relation to extension of permit  

           Division 1.6--Listed chemical products

   8AR.    Listed chemical products  

   PART 2--APPROVALS--AND REGISTRATION

           Division 2.1A--Pre-application assessments and assistance

   8AS.    APVMA may provide technical assessments  
   8AT.    APVMA may provide pre - application assistance  

           Division 2.1--Granting or refusing approvals and registrations

              Subdivision 2.1.1--Preliminary applications--summaries of applications

   8B.     Summaries of applications for active constituents for chemical products  
   8D.     Summaries of applications for chemical products that are not the same as a registered chemical product  
   8E.     Summaries of applications for chemical products that are the same as a registered chemical product  

              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

   17C.    Conditions of approval or registration--active constituents and chemical products  
   18.     Conditions of registration of chemical products--containers  

              Subdivision 2.1.6--Conditions of approval--labels

   18B.    Prescribed conditions for approval of 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  
   18J.    Identifying information recorded for holder and nominated agent  

              Subdivision 2.1.6A--Incorrect particulars and conditions

   18K.    Incorrect particulars and conditions APVMA must correct  

           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

   19AD.   Summaries of applications for variation for chemical products  

              Subdivision 2.2.2--Interchangeable constituent determinations

   19AEA.  Interchangeable constituent determinations  
   19AEB.  Applying for an interchangeable constituent determination  
   19AEC.  Limits on information that may be used for interchangeable constituent determinations  

           Division 2.3--Reconsideration of approval or registration

   20.     Reconsideration work plan  
   21.     Period for giving information, reports, results or samples  
   22.     Notice of decision on reconsideration  
   22AA.   Reconsideration by APVMA of approval of label  

           Division 2.6--Late applications

   23.     Late applications for renewal of registration of chemical product  

           Division 2.7--Renewal of registration

   23A.    When renewed registration ends  

   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 3.1--Notices

   24.     Prescribed information--notice to primary holder  
   25.     Prescribed information--notice to secondary holder  

           Division 3.2--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 parties notice of hearing  
   32.     Arbitrator's powers if holder does not attend 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 information  
   37.     Arbitrator's costs  
   38.     Holders' cost of arbitration  
   39.     Arbitrator exonerated from liability  

   PART 4--CONTROL--OF CHEMICAL PRODUCTS

           Division 4.1--General

   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  
   42A.    Substances and chemical products exempted from section 88 of the Code  
   43.     When statements about chemical products can be made or reported  
   43A.    Division 3 of Part 4 of the Code does not apply to listed chemical products or reserved chemical products  
   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 4.2--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  
   55A.    Prescribed standards for supplied substances  
   56.     Analysis at an accredited laboratory  

   PART 5A--RECALL--NOTICES

   56A.    When a notice of recall is not required to be published  

   PART 6--PERMITS

   57.     Requirements for issue of permit on application  
   57A.    Requirements for issue of permit on APVMA's own initiative  
   57B.    Duration of permit--extension for further period  

   PART 7--MANUFACTURE--OF CHEMICAL PRODUCTS

   59.     Part 8 of the Code does not apply to listed chemical products, reserved chemical products and certain other products  
   59A.    Manufacture of chemical products--exempt persons--single step  
   59B.    Manufacture of chemical products--exempt persons--chemical product that ceases to be prescribed  
   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  
   59E.    Requirements for issue of licence  
   60.     Licence condition--holder to give information about manufacture  
   61.     Licence conditions--general  
   61A.    Determination following GMP audit  
   62.     Licence condition--naming persons in control of production etc  

   PART 8--ENFORCEMENT

   63.     Method of securing samples  
   64.     Infringement notices  

   PART 9--MISCELLANEOUS

           Division 9.1--Information

   65.     Information that must be given electronically  
   65A.    Period for giving additional information, report or sample--applications  
   65B.    Period for giving additional information, report or sample--suspensions and cancellations  
   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  
   69AAA.  Disclosure of information given with applications under these Regulations  

           Division 9.2--Fees

   69A.    Payment of fees  
   69AA.   Prescribed fee for notices of notifiable variations  
   69B.    Fees for pre - application assistance  
   70.     Fees for applications  
   70A.    Modular assessment fees  
   70B.    Recategorised applications  
   71A.    Fees for continued registration of chemical product  
   71B.    Overseas GMP compliance assessment  
   71C.    Fees for applications relating to holder or nominated agent  
   72.     Remission and waiver of fees for applications  
   72A.    Fees for licences  
   73.     Fees for copies and extracts  
   73A.    Fees for converting information and documents into electronic form  

           Division 9.3--Notification, assessment periods and review

   75.     Notification that application has been received  
   76.     Period within which APVMA is to determine application  
   76A.    Extended assessment periods  
   76B.    Extension of assessment period or extended assessment period for recategorised applications  
   77.     Meaning of modular assessment period  
   78.     Commencement of assessment period  
   78A.    Period for determining applications relating to holders and nominated agents  
   78AA.   Period for determining applications for renewal of registration  
   78B.    Period within which APVMA is to conclude reconsiderations  
   78C.    Review of decisions by Administrative Appeals Tribunal  

           Division 9.4--Logo of APVMA

   79.     Logo of the APVMA  

   PART 10--TRANSITIONAL--AND APPLICATION PROVISIONS

           Division 10.1--Transitional provisions for Agricultural and Veterinary Chemicals Legislation Amendment Act 2013

   80.     Definitions  
   82.     Continuation of old Code requirements for old Code applications  
   83.     Preliminary notices issued under old Code  
   84.     Assessment periods for old Code applications  
   85.     Reconsiderations commenced under old Code  

           Division 10.2--Amendments made by the Agricultural and Veterinary Chemicals Legislation Amendment Regulation 2014

   86.     Operation of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment Regulation 2014  

           Division 10.3--Application of amendments made by the Agricultural and Veterinary Chemicals Code Amendment (Removal of Re-approvals and Re-registrations) Regulation 2014

   87.     Application of amendments in relation to existing approvals of labels  

           Division 10.4--Amendments made by the Agricultural and Veterinary Chemicals Legislation Amendment (Timeshift Applications and Other Measures) Regulations 2019

   88.     Definitions  
   89.     Applications  
   90.     Exemption from operation of section 88 of the Code  

           Division 10.5--Amendments made by the Agricultural and Veterinary Chemicals Code Amendment (Cost Recovery) Regulations 2020

   91.     Notices of intention to supply hormonal growth promotant  
   92.     Applications  

           Division 10.6--Amendments made by the Agricultural and Veterinary Chemicals Code Amendment (Miscellaneous Measures) Regulations 2021

   93.     Minor use  

           Division 10.7--Amendments made by the Agricultural and Veterinary Chemicals Legislation Amendment (Improvements) Regulations 2021

   94.     Applications for variation for chemical products  

           Division 10.8--Amendments made by the Agricultural and Veterinary Chemicals Code Amendment (Cost Recovery and Other Measures) Regulations 2022

   95.     Application of amendments  
           SCHEDULE 1 Date-controlled agricultural chemical products
           SCHEDULE 3 Definition of agricultural chemical product
           SCHEDULE 3AA Definition of veterinary chemical product
           SCHEDULE 3B Listed chemical products
           SCHEDULE 3C Reserved Schedule
           SCHEDULE 4 Restricted chemical products
           SCHEDULE 5A Infringement notices
           SCHEDULE 6 Application 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)

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