Federal Register of Legislation - Australian Government

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Poisons Standard 2010

Authoritative Version
Standards/Other as made
This Standard substitutes the Poisons Standard 2009 and provides the Uniform Scheduling of Medicines and Poisons No. 1, as set out in Schedule 1.
Administered by: Health
General Comments: See subsection 3(2) for entries of 7 substances commencing on 1 January 2011.
Registered 27 Aug 2010
Tabling HistoryDate
Tabled HR28-Sep-2010
Tabled Senate28-Sep-2010
Date ceased to have effect 09 Aug 2011
Ceased by Poisons Standard 2011
Ceasing Comments This Standard was superseded by Poisons Standard 2011

 

EXPLANATORY STATEMENT

 

 Subject:           Therapeutic Goods Act 1989

 

Poisons Standard 2010

 

 

The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.

 

Subsection 52D(2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the current Poisons Standard or prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.  This authority had previously been provided to an independent statutory committee established under the TG Act, the National Drugs and Poisons Schedule Committee (NDPSC), which no longer exists due to the implementation of amendments to the TG Act that commenced on 1 July 2010.

 

Part 6-3 of the TG Act provides for the basis for a uniform system of access controls for goods containing scheduled substances.  The scheduling of substances allows restrictions to be placed on their supply to the public, in the interest of public health and safety.  The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse and abuse of, scheduled substances.  The TG Act also establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (section 52B) and the Advisory Committee on Chemicals Scheduling (section 52C).  These statutory committees provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions and in relation to any other matters referred to them by the Secretary.  Part 6-3 of the TG Act also provides for the constitution of those committees and other administrative arrangements in relation to the carrying out of their functions in accordance with the regulations.   

 

The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of drugs and poisons into nine different Schedules signifying the degree of risk and the degree of control recommended to be exercised over their availability to the public.  

 

The purpose of this instrument is to prepare a new Poisons Standard (cited as Poisons Standard 2010) in substitution for the previous Poisons Standard.  The previous Poisons Standard that is being substituted is the Poisons Standard 2009 (registered on FRLI on 6 August 2009), together with the three subsequent amendments: Poisons Standard Amendment No.2 of 2009; Poisons Standard Amendment No.3 of 2009; and Poisons Standard Amendment No.1 of 2010.  The previous Poisons Standard consisted of decisions of the NDPSC.

 

The Poisons Standard 2010 is a consolidation of the Poisons Standard 2009 with its three amendments, together with additional scheduling decisions made by the delegate of the Secretary after 1 July 2010.  It is the first instrument made by the delegate of the Secretary after the commencement of the new scheduling arrangements. 

 

·        Poisons Standard 2009

 

The amendments to the Poisons Standard 2009 set out in Poisons Standard Amendment No.2 of 2009 consist of decisions made by the NDPSC at its February 2009 meeting and confirmed at its June 2009 meeting.  These amendments commenced on 1 September 2009.

 

The amendments to the Poisons Standard 2009 set out in Poisons Standard Amendment No.3 of 2009 consist of decisions made by the NDPSC at its June 2009 meeting and confirmed at its October 2009 meeting.  These amendments commenced on 1 January 2009.

 

The amendments to the Poisons Standard 2009 set out in Poisons Standard Amendment No.1 of 2010 consist of decisions made by the NDPSC at its October 2009 meeting and confirmed at its February 2010 meeting.  These amendments commenced on 1 May 2009.

 

The NDPSC, in making the above decisions, was required to undergo a consultation process that involved inviting and considering public submissions before making a decision in relation to the scheduling of drugs and poisons.  These requirements included inviting persons who made a valid public submission, before the amendment was made, to make a further submission, and a requirement that the NDPSC must consider any such further submissions before determining whether to confirm, vary or set aside the amendment to the Poisons Standard.

 

·        Decisions made by the NDPSC on or after 1 January 2010

 

The NDPSC also made scheduling decisions at the February 2010 and June 2010 meetings.  Item 13 of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the Amendment Act) in relation to the new scheduling framework sets out the relevant provision on how amendments proposed by the NDPSC on or after 1 January 2010 are to be dealt with.  Item 13 provides that the Secretary, or a delegate of the Secretary, in relation to the making of the first instrument under subsection 52D(2) of the TG Act on or after 1 July 2010, must have regard to any amendments to the current Poisons Standard by the NDPSC after 1 January 2010 which have not been implemented in the current Poisons Standard before 1 July 2010. 

 

The delegate of the Secretary confirmed the scheduling decisions made by the NDPSC at the February and June 2010 NDPSC meetings and have been implemented by the Poisons Standard 2010.  The NDPSC recommended that all such decisions from the February 2010 meeting, and most of those from the June 2010 meeting, be implemented on 1 September 2010.  Some June 2010 decisions had a recommended implementation date of 1 January 2011, to minimise any impact to industry.

 

 

 

 

·        Decisions made by the delegate on or after 1 July 2010

 

The delegate has also made a number of scheduling decisions that would amend the Poisons Standard 2009 and has subsequently been implemented in the Poisons Standard 2010.  These decisions were in regard to a number of new chemical substances that are the active ingredients of new prescription only medicines which have been recently granted registration under the TG Act.  These new chemical substances have not been previously included in the Poisons Standard (i.e. scheduled) but which the delegate of the Secretary decided did not require referral to an expert advisory committee.  The statutory procedures set out under the TG Act and the Therapeutic Goods Regulations 1990 (the Regulations) allow the delegate to consider applications under section 52EAA of the TG Act to amend the current Poisons Standard, or to initiate an amendment or the making of a new document to substitute the current Poisons Standard on the Secretary’s (or a delegate of the Secretary) own initiative (see subsection 52D(3) of the TG Act).  Regulation 42ZCZU of the Regulations allows the Secretary, or her delegate, to make a final scheduling decision in response to an application under section 52EAA to amend the current Poisons Standard, if the decision aligns with the proposal in the application and without referring the matter for consideration by an expert advisory committee.

 

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).  However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).

 

The Schedules of poisons and drugs contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes.  The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act.  For example, the TG Act and Regulations prohibit the publication of advertisements about prescription medicines (included in Schedule 4 of the Poisons Standard), over the counter medicines (included in Schedule 3 and not included in Appendix H of the Poisons Standard) and medicines included in Schedule 8 or 9, or captured by Appendix C of the Poisons Standard in specified media such as magazines, newspapers, television, radio, cinematograph films and certain displays.

 

The process for the making of scheduling decisions that were implemented in the Poisons Standard 2009 (including amendments that commence on 1 September 2009, 1 January 2010 and 1 May 2010) involved significant NDPSC consultation with industry stakeholders and, as such, they are already aware of these amendments (as detailed above) which have been implemented by States and Territories. 

 

The amendments made by the delegate of the Secretary and which were implemented in the Poisons Standard 2010 relate to the considerations of substances for human therapeutic use which had not previously been scheduled and which had been determined to have very low likelihood of broader regulatory impact.  These decisions involved active ingredients of registered medicines which were considered “new chemical entities” as they have never been entered in the Australian Register of Therapeutic Goods for their lawful supply in Australia.  

 

The amendments resulting from the NDPSC decisions made on or after 1 January 2010 have undergone consultation processes as set out in the repealed provisions in the Regulations in relation scheduling.  Decisions arising from the February 2010 NDPSC meeting have undergone the full consultation process, while those decisions that have arisen from the June 2010 NDPSC meeting had undergone the pre-meeting consultation process, but not the subsequent post-meeting consultation process.  Under the NDPSC process, if an interested party made a valid public submission in response to the pre-meeting notice about matters which were to be considered for scheduling, they were invited to make further submissions on any consequential decision which would have resulted in an amendment to the current Poisons Standard.  As a consequence of the new scheduling arrangements which commenced on 1 July 2010 there was no avenue for allowing any such further submissions on June 2010 decisions. 

 

While the need for consultations such as those prescribed in the repealed provisions in the Regulations are not specifically described in the transitional provisions set out in the Amendment Act it was agreed by the NDPSC that where practical, only those June 2010 NDPSC decisions which would not normally be expected to give rise to further submissions should be finalised.  In general this approach was followed.  There were some few items where the NDPSC pragmatically agreed that the decision was largely aligned with the spirit of the interested parties, even if not to every last detail, and that the decision could still be recommended for inclusion in SUSMP 1.  In addition, other proposed amendments required to change the current SUSDP 24 (and its three amendments) for incorporation into the SUSMP 1 were considered at the June 2010 NDPSC meeting.  Members recognised that it was a practical necessity for transitioning to the new arrangements that the NDPSC make a decision on this matter for consideration by the delegate for inclusion into SUSMP 1, regardless of whether these changes were disputed in pre-meeting comments (pre-meeting comments, as was always the case, were taken into consideration by the June 2010 meeting in reaching its decision on these matters).  These proposed amendments had been developed by the National Co-ordinating Committee on Therapeutic Goods (NCCTG) (as the committee which oversees scheduling policy).  This process included public consultation.  In addition, unlike many matters going before NDPSC, these proposed amendments, and a summary of reasons for these changes, were made available on the NDPSC website which was referenced in the June 2010 pre-meeting notice.

 

The Poisons Standard 2010 consists of the following provisions.

 

Section 1 of this instrument provides that the name of the instrument is the Poisons Standard 2010. 

 

Section 2 of this instrument provides that the Poisons Standard 2010 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No.1 as set out in Schedule 1.

 

Section 3 of this instrument provides the commencement date of this instrument at 1 September 2010 except for those specified amendments relating to entries of substances in the SUSMP in specified Parts, Schedules or Appendices which have a commencement date of 1 January 2011.