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Amendments to the regulations, 2010

23 June 2010

As part of the regulatory reform program a number of amendments have been made to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002, both made under the Therapeutic Goods Act 1989.

The principal amendments:

In addition, information on proposed regulation changes to give effect to a new biologicals regulatory framework is also available below.

Revised fees and charges

The Therapeutic Goods Amendment Regulations 2010 (No.3), the Therapeutic Goods (Charges) Amendment Regulations 2010 (No.1) and the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No.2) were made by the Governor General on 15 June 2010 in order to increase most TGA fees and charges by 2.4%. In applying the 2.4% increase, fees and charges have been rounded to the nearest $10 for items under $10,000 and to the nearest $100 for items $10,000 or more. Due to rounding, certain items, which are currently $200 or below will remain unchanged.

The revised fees and charges will take effect from 1 July 2010 and will apply to all TGA fees and charges for the 2010-11 financial year.

The revised fees and charges schedule will be placed on this website.

Revised scheduling arrangements - regulation changes

The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. This is aimed at minimising the risks of poisoning from, and the misuse and abuse of, scheduled substances.

The Therapeutic Goods Amendment (2009 Measures No 2) Act 2009 amended the Therapeutic Goods Act 1989 (the Act) in a number of ways including to implement revised arrangements for the scheduling of medicines and chemicals. The revised arrangements are to commence on 1 July 2010 and can be viewed on the ComLaw website.

Details of the revised arrangements are set out in the Therapeutic Goods Amendment Regulations 2010 (No.2). These regulations were made by the Governor General on 15 June 2010.

Consultation on the Scheduling Policy Framework (SPF) and the Poisons Standard were conducted from 11 April to 29 May 2009. In line with the Government's commitment to conduct further consultation on the details of the arrangements related to implementation of the new framework, the draft regulations were previously provided for public comment.

Together with the SPF, the amending regulations will provide support to the provisions within the amending Act and in doing so provide guidance to applicants, committees and decision-makers within the new framework.

Further information on the draft regulations to implement the revised scheduling framework can be viewed at: Consultation: Draft regulations to implement the revised scheduling framework.

New in-vitro diagnostic devices (IVDs) framework

The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No.1) (the MD Amendment Regulations) and the Therapeutic Goods Amendment Regulations 2010 (No.1) (the TG Amendment Regulations), taken together, establish a new, specialised regulatory framework for in-vitro diagnostic medical devices (IVDs) and set out transitional arrangements for moving from the current regulatory framework to the new requirements under Chapter 4 of the Act.

The MD Amendment Regulations and the TGA Amendment Regulations were both registered on FRLI on 3 March 2010 and both commence on 1 July 2010.

The new regulatory framework for IVDs sets out more comprehensive and consistent requirements for IVDs, and harmonises Australia's regulation of IVDs with those recommended by the Global Harmonisation Task Force formed to develop guidelines for a global model of regulation for medical devices (whose members include the United States, Europe, Canada, Japan and Australia).

The MD Amendment Regulations set out a number of important measures concerning the regulation of IVDs including:

  • regarding IVDs as medical devices,
  • classifying IVDs according to their intended purpose and the public health and personal risks associated with their use, and
  • setting out the conformity assessment procedures and essential principles applying in relation to them.

The TG Amendment Regulations and the MD Amendment Regulations provide for the transitioning, over a 4 year period, from the current regulatory framework for IVDs under Chapter 3 of the Act to the new regulatory framework under Chapter 4 of the Act. They also set out a number of amendments that are consequential on the establishment of the new framework under the Therapeutic Goods (Medical Devices) Regulations 2002.

Under the new framework, Class 1, Class 2 and Class 3 in-house IVDs are not required to be included in the Register. An in-house IVD is an IVD that is developed within the confines and scope of an Australian medical laboratory or network of laboratories and not supplied for use outside that laboratory or network.

The TG Amendment Regulations also make a small number of minor changes to the Therapeutic Goods Regulations 1990 not related to IVDs, such as updating old references to Branches of the TGA.

Further information on the new IVD framework can be found on the IVD web page.

Advisory committees

The Therapeutic Goods Amendment Regulations 2009 No. 6 (the Regulations) amend the Therapeutic Goods Regulations 1990 to provide for the new advisory committee arrangements. Most of the changes introduced by the Regulations commenced on 1 January 2010, with the exception of the changes dealing with the establishment of and arrangements regarding the new Advisory Committee on Complementary Medicines, which commenced on 25 January 2010.

The Regulations were registered on the Federal Register of Legislative Instruments (FRLI) on 16 December 2009, and can be viewed on the ComLaw website.

The Regulations establish the following advisory committees:

The Therapeutic Goods Committee will retain its existing name, however, membership arrangements have changed.

The primary purpose of the regulation amendments is to increase transparency and to provide for consistency across committee operations. Arrangements for transition across to the new arrangements have been put in place.

Further information on each committee is available by clicking on the committee names, above.

Infringement notices

The Therapeutic Goods Amendment Regulations 2009 (No.5) (the Regulations) enabled the issuing of infringement notices.

The Regulations were registered on FRLI on 10 September 2009, and commenced on 11 September 2009. The Regulations can be viewed on the ComLaw website.

The Regulations amended the Therapeutic Goods Regulations 1990 to give effect to sections 42YJ and 42YK of the Act by setting out the details of the infringement notices scheme established under those provisions.

The Regulations allow an issuing officer (the National Manager of the TGA, or an Assistant Secretary of a Branch or Office of the TGA) to give a person alleged to have committed a strict liability offence or contravened a civil penalty provision of the Act the option of addressing that matter by paying a penalty specified in an infringement notice, as an alternative to being taken to court.

A person issued with an infringement notice is under no compulsion to pay the penalty stated in the notice, and may elect instead to have the matter dealt with by a court. If a person issued with a notice does pay the penalty in accordance with the Regulations, the person's liability for the offence or contravention will be discharged in full, and no further action may be taken against the person for the offence or contravention.

The Regulations also introduced measures permitting persons issued with an infringement notice to apply for an extension of time of up to 28 days in which to pay the penalty specified in the notice, or for approval to pay that penalty in instalments over a period of up to 6 months.

Further details regarding the infringement notices scheme, including in relation to maximum possible levels of penalties that may be specified in infringement notices, can be found in the document "Enforcement guidelines Therapeutic Goods Amendment Act (No. 1) 2006 Implementation - General Principles".

Important minor amendments

  • Enabling medical devices to be transferred to another person. This change was introduced by the Therapeutic Goods Amendment Regulations 2009 (No. 2), which commenced on 26 June 2009. Prior to this change, kinds of medical devices entered in the Australian Register of Therapeutic Goods (the Register) were not able to be transferred if the sponsor of the device changed.

    This change introduced new subregulation 10F(4A) to enable such a transfer to occur, so that the Register may be amended when a person, in relation to whom a kind of medical device is included in the Register, transfers or assigns his or her business or interest to another person.
  • Provide details for a low value, low volume exemption for goods in the Register from the requirement to pay annual charges. Amendments were made by the Therapeutic Goods Amendment Regulations 2009 (No. 3) to set out when the annual charge is payable for a new registration, listing or the inclusion of a kind of medical device in the Register. The changes introduced by these regulations also include the setting out of criteria and requirements applying to the granting of an exemption from the requirement to pay an annual charge for a person whose turnover of therapeutic goods entered in the Register is of low value. The exemption commenced on 1 July 2009. Information on seeking a low value exemption and the current thresholds is available at: Guidance on applying for low value turnover exemption from annual charges.

Biologicals regulatory framework - proposed regulation changes

The Therapeutic Goods (2009 Measures No. 3) Act 2010 (the Measures No.3 Act) introduced a number of amendments to the Therapeutic Goods Act 1989 (the Act), including the implementation of a new regulatory framework for biological therapeutic goods. The Measures No. 3 Act was given Royal Assent on 31 May 2010.

The Measures No.3 Act provides that details of the new framework are to be given effect for through amendments to the Therapeutic Goods Regulations 1990 and other subordinate legislation. The provisions of the Measures No.3 Act dealing with biological therapeutic goods are set out in Schedule 1 to that Act, which is to commence on a day to be Proclaimed within 12 months of Royal Assent.

The Measures No.3 Act can be viewed on the ComLaw website and information on the Act can be viewed at: Fourth Act to enhance the Therapeutic Goods Act 1989 given Royal Assent. Information on the proposed regulation changes is available at: Biologicals framework implementation.