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MEDICINES, POISONS AND THERAPEUTIC GOODS AMENDMENT REGULATION 2014 (NO 1) (NO 23 OF 2014)
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2014 (No 1)
Subordinate law SL2014–23
made under the
Medicines, Poisons and Therapeutic Goods Act 2008, s184 (Regulation-making power)
EXPLANATORY STATEMENT
Overview
The
Therapeutic Goods Administration (TGA) administers the Standard for the Uniform
Scheduling of Medicines and Poisons (the SUSMP), which classes medicines and
poisons into schedules. The ACT adopts the SUSMP under the Medicines,
Poisons and Therapeutic Goods Act 2008 (the MPTG Act) to
regulate the supply of scheduled medicines in the ACT. The SUSMP also contains
appendices which subject some substances listed in the schedules to additional
exceptions or restrictions.
The objective of the MPTG Act is to promote
and protect public health and safety by minimising medicinal misadventure with,
and diversion of, regulated substances, and the manufacture of regulated
substances that are subject to abuse. The MPTG Act also has the purpose of
ensuring that consumers of prescription and non-prescription medicines have
adequate information to allow them to use medicines safely and effectively. The
MPTG Act outlines a range of offences relating to dealings with regulated
substances according to their listing in the SUSMP.
The Medicines,
Poisons and Therapeutic Goods Regulation 2008 (the MPTG Regulation) provides the
detail for the regulatory framework established by the MPTG Act. The MPTG
Regulation sets out which health professionals are able to prescribe, administer
and dispense medicine, and conditions relating to such dealings. Some
provisions of the MPTG Regulation prescribe additional information required for
licences or authorisations, whereas other provisions impose statutory licence
conditions. There are also provisions of the Regulation specifying requirements
for activities such as labelling or packaging.
The TGA announced that
sodium oxybate will be scheduled as a schedule 8 and Appendix D medicine under
the SUSMP from 1 October 2014. Sodium oxybate is a salt derivative of gamma
hydroxybutyrate and is indicated for the treatment of severe narcolepsy, sleep
fragmentation and cataplexy. The change will allow specialists practicing in
the areas of paediatrics, neurology and sleep medicine to prescribe sodium
oxybate.
While changes to the SUSMP are adopted under the MPTG Act,
local prescriber restrictions for Appendix D medicines under the MPTG Regulation
require amendment to give specialist prescribers authority to prescribe sodium
oxybate.
An additional change to the MPTG Regulation is also required to
substitute reference to the
Australian Code of Good Wholesaling Practice
for Therapeutic Goods for Human Use with the Australian Code of Good
Wholesaling Practice for Medicines in Schedules 2, 3, 4 & 8. This update
will help ensure that ACT medicine wholesalers act in accordance with best
practice guidelines.
Details
A detailed explanation of
each clause of the Regulation follows.
Clauses
Clause 1 Name of Regulation
The first clause of the
Regulation declares the name of the Regulation to be the Medicines, Poisons and
Therapeutic Goods Amendment Regulation 2014 (No 1).
Clause 2 Commencement
Pursuant to this provision, the Regulation is to commence the day after
notification with exception to section 11. Section 11 is to commence on 1
October 2014.
Due to the operation of section 75(1) of the
Legislation Act 2001 (the Legislation Act) the naming and
commencement provisions of this Regulation, clauses 1 and 2, commence
automatically on the day the Regulation is notified. A note to that effect is
included in the provision.
Clause 3 Legislation amended
This provision alerts the reader that this Regulation amends the MPTG
Regulation.
Upon commencement, this Regulation will alter the MPTG
Regulation in accordance with the provisions that this Regulation contains.
This Regulation will then be immediately repealed.
Consequentially,
from the date that this Regulation commences a new republication of the MPTG
Regulation will be available. That new republication will feature the
alterations made by this Regulation.
Clause 4 Section 270 (a)(i)
Section 270 of the MPTG Regulation specifies conditions for wholesalers
supplying medicines under corresponding laws.
This clause substitutes
reference to the Australian Code of Good Wholesaling Practice for Therapeutic
Goods for Human Use with the updated Australian Code of Good Wholesaling
Practice for Medicines in Schedules 2, 3, 4 & 8. This update is
required in order to reference the most recent medicine wholesaler’s code
and promote best practice guidelines for ACT medicines wholesale.
Clause 5 Section 270 (a), note
This clause substitutes the
note under section 270 of the MPTG Regulation in-line with earlier
amendments.
Clause 6 Section 461 (b) (i)
Section 461 of the MPTG Regulation specifies authorisation conditions for
medicines wholesalers licences as issued under section 44 of the Medicines,
Poisons and Therapeutic Goods Act 2008.
This clause substitutes
reference to the Australian Code of Good Wholesaling Practice for Therapeutic
Goods for Human Use with the updated Australian Code of Good Wholesaling
Practice for Medicines in Schedules 2, 3, 4 & 8. This update applies the
most recent medicines wholesaler code as an authorisation condition for
wholesaler licences in line with best practice guidelines.
Clause 7 Section 461 (b), note
This clause
substitutes the note under section 461 (b) of the MPTG Regulation in-line with
amendments made by Clause 6 of this Regulation.
Clause 8 Section 650, note
This clause updates the note under
section 650 of the MPTG Regulation to provide the reader with clearer
information about where the referenced document can be accessed.
Clause 9 New section 863 (aa) and (ab)
Section 863 of the MPTG Regulation displaces the operation of section 47(6)
of the Legislation Act 2001 in regard to a range of publications
made by a government or agency other than the ACT Government. Displacing the
operation of section 47(6) of the Legislation Act 2001 removes the
requirement that the applied documents be a notifiable instrument under the MPTG
Regulation.
This clause inserts subsections 863 (aa) and 863 (ab) in order to
list the Australian Code of Good Wholesaling Practice for Medicines in
Schedules 2, 3, 4 & 8 and Medicines Australia Code of Conduct as
documents for which section 47(6) of the Legislation Act 2001 does not
apply.
Clause 10 Section 863, new notes
This clause inserts new notes
3A and 3B under section 863 of the MPTG Regulation to inform the reader that the
Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3,
4 & 8 is accessible at www.tga.gov.au
and the Medicines Australia Code of Conduct is accessible at www.medicinesaustralia.com.au
.
Clause 11 Schedule 3, part 3.2, new item 6
The focus of
Schedule 3 is standing approvals for designated Appendix D medicines. The
Schedule consists of two Parts. Part 3.1 of the Schedule defines the four
different approval conditions that are then placed upon certain specialist
doctors by Part 3.2. Appendix D medicines are listed in the SUSMP.
This
provision inserts a new item 6 into Part 2.3 of Schedule 3. The effect of item 6
is to authorise specialists practising in the specialist area of neurology,
paediatrics or sleep medicine, to prescribe sodium oxybate; the medicine listed
in column 3. Column 4 is left empty, reflecting that no special conditions are
imposed on the prescribing of sodium oxybate. Sodium oxybate is a salt
derivative of gamma hydroxybutyrate and is used to treat patients with severe
narcolepsy, cataplexy and sleep fragmentation.
Clause 12 Dictionary, new definition of Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8
This clause substitutes the current dictionary definition for the
Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human
Use with the Australian Code of Good Wholesaling Practice for Medicines
in Schedules 2, 3, 4 & 8 in-line with earlier amendments. The
dictionary update informs the reader that that the new code has been prepared by
the National Coordinating Committee on Therapeutic Goods, as in force from time
to time.
The amendment also inserts a note to inform the reader that the
Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3,
4 & 8 is accessible at www.tga.gov.au
.
Clause 13 Dictionary, definition of Australian Code of Good
Wholesaling Practice for Therapeutic Goods for Human Use
This clause
omits the current dictionary definition of the Australian Code of Good
Wholesaling Practice for Therapeutic Goods for Human Use as substituted by
Clause 12 of this Regulation.
Clause 14 Dictionary, definition of medicines Australia
code of conduct , note
This clause updates the note under the MPTG
Regulation’s dictionary definition of medicines Australia code of
conduct to provide the reader with clearer information about where the
Medicines Australia Code of Conduct can be accessed.