Agri-Vet Chemicals Code Regulations 1995 (Superseded Version, 01 Mar 2016 - 31 May 2016)

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Agricultural and Veterinary Chemicals Code Regulations 1995 Citation change

In force Administered by
- Department of Agriculture, Fisheries and Forestry
This item is authorised by the following title:

• Agricultural and Veterinary Chemicals Code Act 1994 Superseded version View latest version View as made version F2016C00203 C36 01 March 2016 - 31 May 2016 This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003

View document Legislative instrument Filter active Table of contents
- Part 1—Preliminary
- Division 1.1A—Name and commencement
- 1 Name of Regulations
- 2 Commencement
- Division 1.1—Definitions
- 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
- 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
- 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 for technical assessment
- 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—Notifiable variations
- 19AE Notifiable variations
- Subdivision 2.2.3—Prescribed variations
- 19AF Prescribed variations
- 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 Protected registered information—notice to primary holder
- 25 Protected registered 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 registration 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
- 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 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 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 9A—Review of prescribed matters
- 80A Purpose of Part 9A
- 80B Definitions for Part 9A
- 80C Repeal of Part 9A
- 80D Reconsideration participation review
- 80E Work health and safety duplication review
- 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 (Animal Feed Reform and Other Measures) Regulation 2015
- 88 Inclusion of excluded stockfood non-active constituents in first ingredient determination
- 89 Repeal of this Division
- Division 10.5—Amendments made by the Agricultural and Veterinary Chemicals Legislation Amendment (Simplified Formulation Variations and Other Measures) Regulation 2015
- 90 Operation of amendments to applications for the renewal of the registration of a chemical product
- 91 Repeal of this Division
- Schedule 1—Date-controlled agricultural chemical products
- Schedule 3—Definition of agricultural chemical product
- Part 1—Preliminary
- 1 Definitions
- Part 2—Substances or mixtures declared to be agricultural chemical products
- Part 3—Substances or mixtures declared not to be agricultural chemical products
- Schedule 3AA—Definition of veterinary chemical product
- Part 1—Preliminary
- 1 Definitions
- Part 2—Substances or mixtures declared to be veterinary chemical products
- 2 Substances or mixtures declared to be veterinary chemical products
- Part 3—Substances or mixtures declared not to be veterinary chemical products
- Division 3.1—Substances or mixtures declared not to be veterinary chemical products—general
- 3 Substances or mixtures declared not to be veterinary chemical products
- Division 3.2—Excluded nutritional or digestive products
- 4 Excluded nutritional or digestive products
- 5 Ingredient requirements for excluded nutritional or digestive products
- 6 Claims requirements for excluded nutritional or digestive products
- 7 Labelling requirements for excluded nutritional or digestive products
- 8 Manufacturing requirements for excluded nutritional or digestive products
- Division 3.3—Ingredient determinations
- 9 Ingredient determinations
- 10 Applying for ingredient determinations
- 11 Information that may be used for ingredient determinations
- Schedule 3B—Listed chemical products
- Part 1—Preliminary
- 1 Particulars of listed chemical products
- 2 Active constituents in listed chemical products
- Part 2—Listed chemical products
- Part 3—Active constituents in listed chemical products
- Division 3.1—Agricultural chemical products
- Subdivision 3.1.1 Home swimming pool and spa products
- Division 3.2—Veterinary chemical products
- Subdivision 3.2.1 Joint health products for dogs and horses
- Schedule 3C—Reserved Schedule
- Part 1—Preliminary
- 1 Definitions
- 2 Particulars of reserved chemical products
- 3 Active constituents in reserved chemical products
- Part 2—Reserved chemical products
- Part 3—Active constituents in reserved chemical products
- Division 3.1—Agricultural chemical products
- Subdivision 3.1.1 Disinfectants
- Division 3.2—Veterinary chemical products
- Schedule 4—Restricted chemical products
- Schedule 5A—Infringement notices
- Schedule 6—Application fees and assessment periods
- Part 1—Preliminary
- 1.1 Definitions
- 1.2 When chemical products are closely similar
- 1.3 When chemical products are similar
- 1.4 When chemical products are the same
- 1.5 Meaning of protected information
- 1.6 Effect of Part 2 where information is protected information
- 1.7 Fee when application for registration preceded by application for permit
- Part 2—Table of 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)
- Endnotes
- Endnote 1—About the endnotes
- Endnote 2—Abbreviation key
- Endnote 3—Legislation history
- Endnote 4—Amendment history