Victorian Consolidated Legislation

THERAPEUTIC GOODS (VICTORIA) ACT 1994

No. 79 of 1994
Version incorporating amendments as at 25 January 2008

TABLE OF PROVISIONS

           Section Page

   PART 1-PRELIMINARY

   1.      Purpose
   2.      Commencement
   3.      Definitions
   4.      Definitions in Commonwealth Act
   5.      Interpretation
   6.      Act to bind Crown
   7.      Authorised persons
   8.      Secretary may approve or authorise the supply of certain therapeutic goods
   9.      Power of Minister to exempt
   10.     Kits
   11.     Power to obtain information with respect to therapeutic
           goods

   PART 2-STANDARDS

   12.     Compliance with standards
   13.     Consent may be subject to conditions etc.

   PART 3-AUSTRALIAN REGISTER OF THERAPEUTIC
   GOODS

           Division 1-Preliminary

   14.     Offences by sponsors
   15.     Offence relating to supply of unregistered or unlisted goods
   16.     Hawking of therapeutic goods
   17.     Supply by vending machine
   18.     General offences relating to this Part
   19.     False statements in applications for registration

           Division 2-Registration and listing

   20.     Applications generally
   21.     Applications for registration
   22.     When evaluation fee due for payment
   23.     Payment of evaluation fee by instalments
   24.     Recovery of evaluation fee
   25.     Reduction of evaluation fee where evaluation not
           completed within prescribed period
   26.     Deemed refusal of application
   27.     Evaluation of therapeutic goods
   28.     Listing of therapeutic goods
   29.     Registration or listing number
   30.     Conditions on registration or listing
   31.     Duration of registration or listing
   32.     Notification of adverse effects etc. of goods
   33.     Notification of adverse effects etc. where application
           withdrawn or lapses
   34.     Cancellation of registration or listing
   34A.    Consultation with Gene Technology Regulator
   34B.    Secretary may seek advice about classes of GM products
   34C.    Secretary to take advice into account

           Division 3-General

   35.     Secretary may require information
   36.     Inspection and variation of entries in Register
   37.     Publication of list of goods on Register

   PART 4-MANUFACTURING OF THERAPEUTIC GOODS

   38.     Offences relating to manufacturing and licences
   39.     Application for licence
   40.     Grant of licence
   41.     Term of licence
   42.     Conditions of licences
   43.     Revocation and suspension of licences
   44.     Publication of list of manufacturers etc.

   PART 5-CODES OF PRACTICE

   45.     Codes of Practice
   46.     Status of a Code of Practice
   47.     Procedure for making or adopting Codes of Practice
   48.     Commencement of Code of Practice
   49.     Availability of Codes of Practice
   50.     Tabling in Parliament
   51.     Conviction of offence under Code of Practice
   52.     Requirement to comply with Code of Practice
   53.     Repealed

   PART 6-PAYMENT OF CHARGES

   54.     By whom charges payable
   55.     Time for payment of charges
   56.     Recovery of charges

   PART 7-MISCELLANEOUS

   57.     Monitoring compliance with Act
   58.     Entry and search of premises-evidence of offences
   59.     General powers of authorised persons in relation to premises
   60.     Monitoring warrants
   61.     Offence related warrants
   62.     Identity cards
   63.     Offences
   64.     Evidentiary certificate of Victorian Secretary
   65.     Evidentiary certificates of the Secretary
   66.     Conduct by directors, servants and agents
   67.     Judicial notice
   68.     Delegation
   69.     Offences under this Act and the Commonwealth Act
   70.     Review of decisions excluding decisions under Part 5.
   71.     Review by Victorian Civil and Administrative Tribunal
   72.     Regulations

   PART 8-CONSEQUENTIAL AMENDMENTS AND TRANSITIONAL PROVISIONS

   73.     Amendments to the Health Act 1958.
   74.     Consequential amendment to the Food Act 1984.
   75.     Transitional arrangements for Part 4.
   76.     Repealed
   77.     Transitional arrangements for goods required to be registered
           or listed
           ---------------
           ENDNOTES
           1. General Information
           2. Table of Amendments
           3. Explanatory Details