Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990

- made under the Therapeutic Goods Act 1989

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Name of Regulations [see Note 1]  
   2.      Interpretation  
   2A.     Authorised officers  
   3.      Corresponding State law  
   3AA.    Unacceptable presentation of therapeutic goods -- prescribed class of medicine  
   3A.     Unacceptable presentations  

   PART 2--ADVERTISEMENTS

           Division 1--Application of Part

   4.      Application of Part 2  
   4A.     Interpretation  

           Division 2--Advertisements for which approval is needed

   5B.     Interpretation  
   5BA.    Means that are not broadcast media  
   5C.     Application of Division  
   5F.     Applications for approval of advertisements  
   5G.     Approval of advertisements  
   5H.     Notice of approval or refusal to approve an advertisement  
   5J.     Distinguishing numbers for approved advertisements  
   5K.     Variation of conditions of approval  
   5L.     Withdrawal of approval  
   5M.     Review by Minister of decisions of the Secretary  
   5N.     Notice of Minister's decisions  
   5P.     Review by Tribunal of decisions of the Minister  
   5Q.     Delegations  

           Division 3--General provisions about advertising therapeutic goods

   6.      Restricted representations  
   6AA.    Prescribed committees  
   6A.     Approval of use of restricted representation -- public interest criteria  
   6B.     Prohibited and required representations  
   7.      Exempt goods and exempt devices  

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

   8.      Compliance with the Code  
   8A.     Publication of generic information  

           Division 5--General

   9.      Orders about advertisements or generic information  

   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)  
   10A.    Change of person in whose name goods are listed or registered  
   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  

           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  
   10I.    Re-assignment of biological numbers  
   10J.    Notice of reassignment of biological numbers  

   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 special and experimental uses -- medicines  
   12C.    Exemptions for special and experimental uses -- biologicals  
   15.     Application of registration or listing number to goods  
   15A.    Conditions of registration of therapeutic goods  
   16.     Listing of Therapeutic Goods  
   16AA.   Documents and other information that may be required (Act subs 31 (2))  
   16AB.   Specified periods  

   PART 3A--APPLICATIONS FOR EVALUATION

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

   16A.    Interpretation -- working day  
   16B.    Notification of acceptance or rejection of application  
   16C.    Periods within which certain evaluations must be made  
   16D.    Periods within which certain applications must be decided  
   16E.    Failure to decide an application within specified time  
   16F.    Applications under subsection 9D (3) of the Act -- periods within which certain decisions must be made  
   16G.    Shorter evaluation period in certain cases  

           Division 2--Applications for evaluation of substances

   16GA.   Evaluation other than evaluation under subsection 9D (1), (2) or (3) or 24 (1) of the Act  

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

   16GB.   Notification of acceptance or rejection of application  
   16GC.   Periods within which certain evaluations must be made  
   16GD.   Periods 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 32DD of the Act  

   PART 3B--ORPHAN DRUGS

   16H.    Orphan drug  
   16I.    Application for orphan drug designation  
   16J.    Orphan drug designation  

   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.     Official analysts  
   26.     Taking of samples for testing  
   26A.    Receiving samples for testing  
   27.     Examination and testing of sample  
   28.     Relevant tests  
   29.     Certificate of official analyst  
   30.     Review of findings of official analyst  
   31.     Payment for samples  
   32.     Offences relating to analysis etc  
   33.     Identity cards  

   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 1--Therapeutic Goods Committee

   34.     Establishment  
   34A.    Functions  
   34B.    Membership  

           Division 1A--Advisory Committee on Prescription Medicines

   35.     Establishment  
   35A.    Functions  
   35B.    Membership  

           Division 1B--Advisory Committee on Non-prescription Medicines

   36.     Establishment  
   36A.    Functions  
   36B.    Membership  

           Division 1C--Advisory Committee on the Safety of Medicines

   37.     Establishment  
   37A.    Functions  
   37B.    Membership  

           Division 1D--Advisory Committee on Medical Devices

   38.     Establishment  
   38A.    Functions  
   38B.    Membership  

           Division 1DA--Advisory Committee on the Safety of Medical Devices

   38C.    Establishment  
   38D.    Functions  
   38E.    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 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 2--Therapeutic Goods Advertising Code Council

   42A.    Therapeutic Goods Advertising Code Council  
   42B.    Functions of the Council  
   42C.    Membership of the Council  
   42D.    Term of office of Council members  
   42E.    Chairperson of the Council  
   42F.    Resignation  
   42G.    Cessation of membership  
   42H.    Alternate members  
   42J.    Observers to Council  
   42K.    Quorum  
   42L.    Meetings  
   42M.    Effect of vacancy  
   42N.    Disclosure of interest  
   42P.    Procedure generally  
   42Q.    Annual report  

           Division 3--Complaints Resolution Panel

              Subdivision 1--General

   42R.    Complaints Resolution Panel  
   42S.    Function of the Panel  
   42T.    Membership of the Panel  
   42U.    Term of office of Panel members  
   42V.    Cessation of office  
   42W.    Alternate members  
   42X.    Observers to Panel  
   42Y.    Quorum  
   42Z.    Meetings  
   42ZA.   Effect of vacancy  
   42ZB.   Disclosure of interest  
   42ZC.   Reports to Council  

              Subdivision 2--Procedure -- Complaints about advertisements and generic information

   42ZCAA. Definitions for Subdivision 2  
   42ZCAB. Complaints about advertisements or generic information  
   42ZCAC. Procedure on receipt of a complaint  
   42ZCAD. Dealing with complaint  
   42ZCAE. Powers of Panel  
   42ZCAF. Withdrawal of complaint  
   42ZCAG. Dealing with subject matter despite withdrawal of complaint  
   42ZCAGA.Panel may refer complaint to another authority  
   42ZCAH. Dealing with matters not specified in complaint  
   42ZCAI. Action that Panel may take  
   42ZCAJ. Panel not to deal with complaint if court proceedings begun  
   42ZCAK. Procedure generally  
   42ZCAL. Register of complaints  

           Division 3A--Advisory Committee on Medicines 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--Charges for registration, listing and inclusion of medical devices and biologicals

   43AAA.  Time for payment of charge  

              Subdivision 2--Low value turnover

   43AAB.  Definitions  
   43AAC.  Application requirements  
   43AAD.  Decision by the Secretary -- exemption application  
   43AAE.  Actual turnover -- new entries in the Register  
   43AAF.  Decision based on actual turnover  
   43AAG.  Requests by Secretary for additional information  
   43AAH.  Decision by the Secretary -- new information  
   43AAI.  Appeal to AAT  

              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  
   44.     Testing of samples -- recovery of costs  
   45.     Waiver or reduction of fees  
   45AA.   Payment of fees in instalments  
   45A.    Limit on application fees -- low value turnover  

   PART 7A--INFRINGEMENT NOTICES

   45B.    Purpose and effect of Part  

   PART 8--MISCELLANEOUS

   46A.    Delegation under the Act  
   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  
   48.     Review of decisions  
           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 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 the operation of Parts 3-2 and 3-2A of the Act subject to conditions
           SCHEDULE 5B Disposal of unused emergency goods and unused emergency biologicals
           SCHEDULE 6 Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act
           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 Patient information documents
           SCHEDULE 13 Patient information documents
           SCHEDULE 14 Designated active ingredients
           SCHEDULE 15 Infringement notices
           SCHEDULE 16 Classes of biologicals