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THERAPEUTIC GOODS REGULATIONS 1990

- made under the Therapeutic Goods Act 1989

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Name of Regulations  
   2.      Interpretation  
   2A.     Authorised officers  
   3.      Corresponding State law  
   3AA.    Unacceptable presentation of therapeutic goods--prescribed class of medicine  
   3A.     Unacceptable presentations  
   3B.     Definitions relating to goods comprising etc. human cells and tissues  
   3C.     Classes of biologicals  

   PART 2--ADVERTISEMENTS

           Division 1--Application of Part

   4.      Application of Part 2  
   4A.     Interpretation  

           Division 3--General provisions about advertising therapeutic goods

   6AA.    Prescribed committees  
   6B.     Prohibited and required representations  
   7.      Prescribed goods for advertising offence and civil penalty  
   7A.     Publisher exception for civil penalty provisions  

           Division 4--Generic information about ingredients or components of therapeutic goods

   8.      Compliance with the Code  

   PART 2A--PATIENT--INFORMATION

   9A.     Information about certain therapeutic goods to be supplied  
   9B.     Information about therapeutic goods manufactured using human embryos  

   PART 2C--AUSTRALIAN--REGISTER OF THERAPEUTIC GOODS

           Division 2C.1--Registered and listed therapeutic goods

   10.     Goods to be included in parts of the Register (Act s 9A)  
   10AAA.  Variation of entries in Register--registered complementary medicines and registered OTC medicines  
   10AAB.  Variation of entries in Register--prescription medicines other than biological medicines  
   10AAC.  Variation of entries in Register--biological medicines  
   10AAD.  Variation of entries in Register--biologicals  
   10AA.   Prescribed requests for variations of entries in Register  
   10AB.   Change of person in whose name goods are listed or registered  
   10AC.   Change of name of person  
   10B.    Transfers within the Register  
   10C.    Re - assignment of registration or listing numbers  
   10D.    Notice of reassignment of registration or listing numbers  

           Division 2C.2--Medical devices included in the Register under Chapter 4

   10E.    Goods to be included in part of the Register for medical devices (Act s 9A)  
   10F.    Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act  
   10FA.   Change of name of person  

           Division 2C.3--Biologicals included in the Register

   10G.    Goods to be included in the part of the Register for biologicals  
   10H.    Change of person for whom a biological is included in the Register under Part 3 - 2A of the Act  
   10HA.   Change of name of person  
   10I.    Re - assignment of biological numbers  
   10J.    Notice of reassignment of biological numbers  

   PART 2CA--PROHIBITION--ON IMPORT, EXPORT OR MANUFACTURE OF CERTAIN THERAPEUTIC GOODS--INTERNATIONAL AGREEMENTS

           Division 1--Prescribed international agreements

   10JA.   Prescribed international agreements  

           Division 2--Prohibition on importation of mercury

   10JB.   Importation of a therapeutic good that is mercury from a non - party to the Minamata Convention is prohibited unless approved by the Secretary before importation  

           Division 3--Prohibition on export of mercury

   10JC.   Export of a therapeutic good that is mercury is prohibited unless approved by the Secretary before exportation  

           Division 4--Applications to import or export mercury

   10JD.   Applications to import or export mercury  
   10JE.   When approval may be granted--importation  
   10JF.   When approval may be granted--export  

           Division 5--Mercury-added products

   10JG.   Import, export and manufacture of therapeutic goods that are mercury - added products  
   10JH.   Manufacture of therapeutic goods containing mercury - added products  

   PART 2D--PROVISIONAL--DETERMINATIONS FOR MEDICINE

   10K.    Applications for provisional determinations  
   10L.    Provisional determinations  

   PART 2E--SCIENTIFIC--ADVICE ABOUT ASPECTS OF QUALITY, SAFETY OR EFFICACY OF MEDICINE

   10M.    Scientific advice about aspects of quality, safety or efficacy of medicine  

   PART 2F--VAPING--GOODS

   10N.    Commercial quantity of vaping goods  
   10P.    Unit of vaping goods  
   10Q.    Permitted quantity  

   PART 3--REGISTRATION--, INCLUSION, LISTING AND EXEMPTION OF THERAPEUTIC GOODS

   11.     Characteristics that separate and distinguish certain medicines from other therapeutic goods  
   11A.    Characteristics that separate and distinguish certain biologicals from other biologicals  
   12.     Exempt goods  
   12A.    Unapproved medicines and biological--exemption in life - threatening cases  
   12AAB.  Disposal of unused emergency goods and unused emergency biologicals  
   12AA.   Applications for special and experimental uses  
   12AB.   Goods imported etc for experimental uses  
   12AC.   Powers of authorised officers in relation to goods imported etc for experimental uses  
   12AD.   Use of goods for experimental purposes--specified conditions  
   12B.    Exemptions for certain uses--medicines  
   12BA.   Authorities for certain uses--therapeutic vaping substances that are not medicines  
   12C.    Exemptions for health practitioners--biologicals  
   15.     Application of registration or listing number to goods  
   15AA.   Clinical trial registries  
   15A.    Conditions of registration and listing of medicines  
   16AA.   Information or documents that Secretary may require  
   16AB.   Specified periods  

   PART 3A--APPLICATIONS--FOR EVALUATION

           Division 1--Preliminary

   16A.    Interpretation-- working day  

           Division 1A--Goods mentioned in Part 1 of Schedule 10

   16C.    Applications for registration--notification of effectiveness and period for completing evaluations--general  
   16D.    Applications for variations--notification of effectiveness and period for deciding applications--general  
   16DA.   Conditions for periods for regulations 16C and 16D  
   16E.    Applications for variations--effect of failure to decide applications within specified period  
   16F.    Applications for variations--shorter period for deciding applications  
   16G.    Applications for registration--shorter period for completing evaluations  

           Division 2--Applications for evaluation of substances

   16GA.   Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act  

           Division 3--Class 2, Class 3 and Class 4 biologicals

   16GC.   Notification of preliminary assessment of applications and periods within which certain evaluations must be made  
   16GD.   Notification of effective request and period within which certain applications must be decided  
   16GE.   Failure to decide an application within specified time  
   16GF.   Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act  

           Division 4--Complementary medicines and certain other listed medicines

   16GG.   Variation of certain entries in the Register--notification of effective requests and period within which decisions must be made  
   16GH.   Registration and listing of certain medicines--notification of preliminary assessment of applications and period within which evaluations must be completed  
   16GI.   Registration and listing of certain medicines--notification of preliminary assessment of applications and period within which decisions on recommendations must be made  
   16GIA.  Period for paying evaluation fee for application under subsection 26BD(1) of the Act  
   16GJ.   Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications  

   PART 3B--DESIGNATED--ORPHAN DRUGS

   16H.    Application to designate medicine as orphan drug  
   16J.    Designation of medicine as orphan drug  
   16K.    Period during which designation is in force  
   16L.    Extension of designation  
   16M.    Revocation of designation  

   PART 3C--THERAPEUTIC--GOODS (PRIORITY APPLICANT) DETERMINATIONS

   16P.    Application of Part  
   16Q.    Application for therapeutic goods (priority applicant) determination  
   16R.    Making of therapeutic goods (priority applicant) determination  
   16S.    Period during which therapeutic goods (priority applicant) determination is in force  
   16T.    Revocation of therapeutic goods (priority applicant) determination  

   PART 3D--BIOLOGICALS--(PRIORITY APPLICANT) DETERMINATIONS

   16U.    Application of Part  
   16V.    Application for biologicals (priority applicant) determination  
   16W.    Making of biologicals (priority applicant) determination  
   16X.    Period during which biologicals (priority applicant) determination is in force  
   16Y.    Revocation of biologicals (priority applicant) determination  

   PART 4--LICENSING--OF MANUFACTURERS

   17.     Exempt goods for the purposes of subsection 34(1) of the Act  
   18.     Exempt Persons  
   19.     Requirements for licence holders  
   20.     Conditions of licences  
   21.     Persons having control of production etc to be named  
   22.     Transfer of licences  

   PART 5--EXAMINATION--, TESTING AND ANALYSIS OF GOODS

   23.     Interpretation  
   24.     Authorised officer--powers and duties  
   25.     Appointment of analysts and official analysts and powers of official analysts  
   26.     Taking of samples for testing  
   26A.    Receiving samples for testing  
   27.     Examination and testing of sample  
   28.     Tests for determining conformity with a standard or compliance with essential principles  
   29.     Certificate of responsible analyst  
   30.     Review of results of examination and analysis  
   31.     Payment for samples  
   32.     Offences relating to analysis etc  
   33.     Production of identity card  

   PART 5A--EXCEPTIONAL--RELEASE

   33A.    Prescribed circumstances under which biologicals may be imported, exported or supplied  
   33B.    Conditions for supply of biologicals  
   33C.    Report on release of nonconforming biological  

   PART 6--COMMITTEES

           Division 1A--Advisory Committee on Medicines

   35.     Establishment  
   35A.    Functions  
   35B.    Membership  

           Division 1D--Advisory Committee on Medical Devices

   38.     Establishment  
   38A.    Functions  
   38B.    Membership  

           Division 1E--Advisory Committee on Complementary Medicines

   39.     Establishment  
   39A.    Functions  
   39B.    Membership  

           Division 1EA--Advisory Committee on Biologicals

   39C.    Establishment  
   39D.    Functions  
   39E.    Membership  

           Division 1EB--Advisory Committee on Vaccines

   39F.    Establishment  
   39G.    Functions  
   39H.    Membership  

           Division 1F--General

   40.     Application of this Division  
   41.     Appointment of members  
   41A.    Appointment of the chair  
   41B.    Resignation or vacancy  
   41C.    Termination of appointment  
   41D.    Leave of absence  
   41E.    Acting members  
   41F.    Committee procedures  
   41G.    Meetings  
   41H.    Presiding member  
   41I.    Quorum  
   41J.    Voting  
   42.     Miscellaneous  

           Division 3A--Advisory Committee on edicines Scheduling

              Subdivision 3A.1--Preliminary

   42ZCA.  Definitions for Division 3A  

              Subdivision 3A.2--Constitution of Committee

   42ZCB.  Membership of Committee  
   42ZCC.  Committee members  
   42ZCD.  Appointed members  
   42ZCE.  Nominated members  
   42ZCF.  Appointment of the Chair and acting Chair  
   42ZCG.  Resignation or vacancy  
   42ZCH.  Termination of appointment  
   42ZCI.  Leave of absence  
   42ZCJ.  Acting members  

              Subdivision 3A.3--Committee meetings

   42ZCK.  Committee meetings  
   42ZCL.  Meeting procedure  
   42ZCM.  Presiding member  
   42ZCN.  Quorum  
   42ZCO.  Voting  
   42ZCP.  Miscellaneous  

           Division 3B--Advisory Committee on Chemicals Scheduling

              Subdivision 3B.1--Preliminary

   42ZCQ.  Definitions for Division 3B  

              Subdivision 3B.2--Constitution of Committee

   42ZCR.  Membership of Committee  
   42ZCS.  Committee members  
   42ZCT.  Appointed members  
   42ZCU.  Nominated members  
   42ZCV.  Appointment of the Chair and acting Chair  
   42ZCW.  Resignation or vacancy  
   42ZCX.  Termination of appointment  
   42ZCY.  Leave of absence  
   42ZCZ.  Acting members  

              Subdivision 3B.3--Committee meetings

   42ZCZA. Committee meetings  
   42ZCZB. Meeting procedure--general  
   42ZCZC. Presiding member  
   42ZCZD. Quorum  
   42ZCZE. Voting  
   42ZCZF. Miscellaneous  

           Division 3C--Joint meetings

   42ZCZG. Joint meetings  
   42ZCZH. Procedure for joint meetings  

           Division 3D--Procedure for amending the current Poisons Standard

              Subdivision 3D.1--Preliminary

   42ZCZI. Definitions for Division 3D  

              Subdivision 3D.2--Procedure if proposed amendment referred to expert advisory committee

   42ZCZJ. Application  
   42ZCZK. Proposed amendment to be referred to expert advisory committee  
   42ZCZL. Consideration of public submissions  
   42ZCZM. Committee to advise Secretary  
   42ZCZN. Interim decision of Secretary  
   42ZCZO. Secretary may make final decision if no interim decision required  
   42ZCZP. Call for further submissions  
   42ZCZQ. Reconsideration of interim decision  
   42ZCZR. Final decision if there is an interim decision  
   42ZCZS. Publication of final decision  

              Subdivision 3D.3--Procedure if proposed amendments not referred to expert advisory committee

   42ZCZT. Application  
   42ZCZU. Final decision without interim decision  
   42ZCZV. Interim decision required if Secretary decides not to amend as requested  
   42ZCZW. Final decision if there is interim decision  
   42ZCZX. Publication of final decision  

   PART 7--CHARGES--FOR REGISTRATION, LISTING AND INCLUSION, LICENCES, EXEMPTIONS, COSTS AND FEES

           Division 1--Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences

              Subdivision 1--Preliminary

   43AAA.  Meaning of turnover and when turnover is of low value  

              Subdivision 1A--Time for payment of certain annual charges

   43AAB.  Time for payment of certain annual charges  

              Subdivision 2--Exemption from liability to pay certain annual charges--therapeutic goods other than IVD devices

   43AAAA. Application  
   43AABA. Purpose of this Subdivision  
   43AABB. Exemption from liability to pay certain annual charges--2014 - 15 financial year--goods entered on Register on or after 1 May 2015 and on or before 30 June 2015  
   43AAC.  Exemption from liability to pay certain annual charges--2015 - 16 financial year  
   43AAD.  Exemption from liability to pay certain annual charges--financial years commencing on or after 1 July 2016  
   43AAE.  Exemption from liability to pay certain annual charges--late notice that turnover was of low value  
   43AAF.  Person may notify Secretary that turnover of goods for financial year will not be of low value  
   43AAG.  Secretary may notify person that annual charge is payable if turnover is not of low value  

              Subdivision 2A--Exemption from liability to pay annual charge--IVD devices

   43AAGA. Purpose of this Subdivision  
   43AAGB. Exemption from liability to pay annual charge--2017 - 18 financial year  
   43AAGC. Exemption from liability to pay annual charge--financial years commencing on or after 1 July 2018  
   43AAGD. Exemption from liability to pay annual charge--late notice that turnover was of low value  
   43AAGE. Person may notify Secretary that turnover of IVD device for financial year will not be of low value  
   43AAGF. Secretary may notify person that annual charge is payable if turnover is not of low value  

              Subdivision 2B--Waiver of certain annual charges

   43AAGG. Purpose of Subdivision  
   43AAH.  Waiver of certain annual charges  

              Subdivision 3--Charges for licensing

   43AAJ.  Licensing charge--reduction in certain circumstances  

           Division 2--Fees and costs

   43.     Fees  
   43A.    When is no application fee payable?  
   43AA.   Fee for evaluation--refund in certain circumstances  
   43AB.   Circumstances in which inspection fee covered by annual charge  
   43AC.   Refund of fees where no evaluation undertaken--registered OTC medicines  
   43ACA.  Refund of fees where no evaluation undertaken--certain registered and listed medicines  
   43AD.   Fee for therapeutic goods (priority applicant) determination application--refund in certain circumstances  
   43AE.   Fee for application for provisional determination relating to medicine--refund in certain circumstances  
   43AF.   Fee for request for variation of certain registered and listed medicines--refund in certain circumstances  
   44.     Testing of samples--recovery of costs  
   45.     Waiver or reduction of fees  
   45AA.   Payment of fees in instalments  

   PART 8--MISCELLANEOUS

   46AA.   Identity cards for authorised officers  
   46A.    Delegation under the Act  
   46B.    Protected persons  
   46.     Release of information  
   47.     Delegation--powers and functions under these Regulations  
   47A.     Delegation--powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act  
   47B.    Provision of information concerning medicines, biologicals and medical devices  
   47C.    Enforceable directions  
   48.     Review of decisions  

   PART 9--TRANSITIONAL

           Division 1--Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1)

   48A.    Definitions  
   48B.    Application of 2010 Amendment Regulations  

           Division 2--Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3)

   49.     Transitional  

           Division 3--Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015

   50.     Application  

           Division 4--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016

   51.     Application  

           Division 5--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017

   52.     Definitions  
   53.     Transitional--continuing application of evaluation fees for variations of permissible ingredients determinations  
   54.     Transitional--existing orphan drug designations  
   55.     Transitional--pending orphan drug designation applications  
   56.     Transitional--fee waivers in relation to certain designations  

           Division 6--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017

   57.     Definitions  
   58.     Application--statements in relation to unapproved medicines and biologicals  
   59.     Transitional--approval of form for statements  

           Division 7--Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018

   60.     Application provisions  
   61.     Operation of Schedule 2--complementary medicines  
   62.     Saving provision  

           Division 8--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

   63.     Application of amendments  

           Division 9--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

   64.     Definitions  
   65.     Transitional provisions--exemptions from Parts 3 - 2 and 3 - 2A of the Act  
   66.     Transitional provisions--exemptions from Part 3 - 3 of the Act  

           Division 10--Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018

   67.     Application  

           Division 11--Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019

   68.     Application and transitional provisions  

           Division 12--Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

              Subdivision A--Definitions

   69.     Definitions  

              Subdivision B--Faecal microbiota transplant products

           70. Faecal microbiota transplant products--Division 4 of Part 3 - 2A of the Act  

   71.     Faecal microbiota transplant products--Part 3 - 3 of the Act  

              Subdivision C--Consumer medicine information documents

   72.     Consumer medicine information documents  

              Subdivision D--Handling and testing of samples

   73.     Handling and testing of samples  

              Subdivision E--Fee waivers and refunds for certain requests relating to prescription opioids

   74.     Fee waivers and refunds for certain requests relating to prescription opioids  

              Subdivision F--Clinical trials

   75.     Clinical trials  

           Division 13--Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

   76.     Approving supply of therapeutic goods under authorised prescriber scheme  
   77.     Preliminary assessment of applications for variation of permissible ingredients determination  

           Division 15--Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021

   79.     Application of amendments made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021  

           Division 16--Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021

   81.     Access to medicines in emergency situations  
   82.     Consumer medicine information documents  
   83.     Approving supply of therapeutic goods under authorised prescriber scheme  

           Division 17--Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

   84.     Amendments made by Division 1 of Part 2 of Schedule 1  
   85.     Amendments made by Division 2 of Part 2 of Schedule 1  

           Division 18--Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

   86.     Extemporaneously - compounded medicinal cannabis products  

           Division 19--Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022

   87.     Reconsideration of decisions  

           Division 20--Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022

   88.     Exempt goods  
   89.     Fee for requests to vary entries in Register  

           Division 21--Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023

   90.     Clinical trials  

           Division 22--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023

   91.     Clinical trials  
   92.     Removal of exemptions for sunscreen preparations  

           Division 23--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023

   93.     Definitions  
   94.     Approving supply of therapeutic goods under authorised prescriber scheme  
   95.     Goods to be included in parts of the Register  
   96.     Exempt goods  
   97.     Transitional vaping manufacturers--exemption from Part 3 - 3 of the Act  

           Division 24--Application provision relating to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024

   98.     Exempt goods  

           Division 25--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024

   99.     Definitions  
   100.    Fee waivers in relation to the Medicines Repurposing Program  
   101.    Examination, testing and analysis of goods  
   102.    Identity cards  
   103.    Sunscreen preparations  

           Division 26--Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024

   104.    Definitions  
   105.    Authorities for therapeutic vaping substances that are not medicines  
   106.    Therapeutic vaping packs  
   107.    Exempt goods  
   108.    Transitional vaping goods--exemption from Part 3 - 2 of the Act  
           SCHEDULE 1 Part 2 does not apply to members of an Australian branch of one of these bodies
           SCHEDULE 2 Prohibited and required representations
           SCHEDULE 3 Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods
           SCHEDULE 4 Therapeutic goods required to be included in the part of the Register for listed goods
           SCHEDULE 5 Therapeutic goods exempt from the operation of Parts 3-2 and 3-2A of the Act
           SCHEDULE 5A Therapeutic goods exempt from operation of Parts 3-2 and 3-2A of Act subject to conditions
           SCHEDULE 5B Disposal of unused emergency goods and unused emergency biologicals
           SCHEDULE 7 Therapeutic goods exempt from the operation of Part 3-3 of the Act unless supplied as pharmaceutical benefits
           SCHEDULE 8 Persons exempt from the operation of Part 3-3 of the Act
           SCHEDULE 9 Fees--therapeutic goods other than biologicals
           SCHEDULE 9A Fees--biologicals
           SCHEDULE 10 Therapeutic goods for evaluation
           SCHEDULE 12 Consumer medicine information documents
           SCHEDULE 13 Consumer medicine information documents
           SCHEDULE 14 Designated active ingredients
           SCHEDULE 16 Classes of biologicals


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