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MEDICINES, POISONS AND THERAPEUTIC GOODS (CONTROLLED MEDICINES) AMENDMENT REGULATION 2016 (NO 1) (NO 16 OF 2016)
Medicines, Poisons and Therapeutic Goods (Controlled Medicines) Amendment Regulation 2016 (No 1)
Subordinate law SL2016–16
made under the
Medicines, Poisons and Therapeutic Goods Act 2008, Section 184 (Regulation-making power)
EXPLANATORY STATEMENT
Overview
The objective of the Medicines, Poisons and Therapeutic Goods Act 2008 (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 Medicines, Poisons and Therapeutic Goods Regulation 2008 (MPTG Regulation) provides the detail for the regulatory framework established by the MPTG Act.
This MPTG Regulation amendment will support increased clinical flexibility
for prescribers when prescribing certain controlled medicines for their patients
within predetermined therapeutic limits for up to three years. The Chief Health
Officer (CHO) will determine therapeutic limits and specific categories of
approval which will be notified by notifiable
instrument.
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 (Controlled Medicines) Amendment Regulation 2016 (No
1).
Clause 2 Commencement
Pursuant to this provision, the Regulation is to commence one month after its notification day.
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This Regulation will then be immediately repealed.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 41 (1) (g) (i)
Clause 5 Section 41 (2) (b)
These provisions remove the
requirement for prescriptions to include ‘relevant approval
particulars’ for controlled medicines.
Clause 6 Section 41 (4), definition of relevant approval particulars
This provision substitutes the meaning ‘relevant approval
particulars’ to remove reference to an approval under section 556 of the
MPTG Regulation requiring the words ‘standing short-term approval’,
an approval under section 557 of the MPTG Regulation requiring the words
‘standing opioid dependency treatment approval’, and an approval
under Division 13.1.13 of the MPTG Regulation requiring the words ‘CHO
approval number’ followed by the approval’s identifying
number.
The requirement for prescriptions for designated Appendix D medicines
to include the words ‘standing approval’ with further details when
prescribed under section 591 of the MPTG Regulation remains in place.
The
requirement for prescriptions for designated Appendix D medicines to include the
words ‘CHO approval number’ followed by the approval’s
identifying number under section 593 of the MPTG Regulation also remains in
place.
Clause 7 Section 561 (1) (c) and (d)
Clause 11 Section 571 (1) (b) and (c)
These provisions establish increased flexibility when prescribers apply for CHO controlled medicines approvals. In addition to applying for the form, strength and quantity of the medicine, these clauses also provide for an application to be made for an approved category. This category approval determination is made under the new section 575 of the MPTG Regulation.
Clause 12 Section 571 (1) (e)
This provision removes the requirements for a CHO controlled medicines approval to include an identifying number for the approval.
Clause 8 Section 561 (2)
Clause 9 Section 563 (b)
Clause 13 Section 571 (2)
These provisions remove reference to provisions relating to a person with a terminal illness. Under the previous legislation, a person with a terminal illness was only permitted to apply for morphine or oxycodone all forms, strengths and quantities for pain management.
Clause 10 Section 564
This provision establishes increased flexibility when prescribers apply for CHO controlled medicines approvals by increasing the validity of approvals from 1 year to 3 years.
Clause 14 New section 575
This new provision enables the CHO to
determine the circumstances relating to a category approval determination. This
category approval determination must be made by notifiable instrument and
supports the establishment of increased flexibility when prescribers apply for
CHO controlled medicines approvals. This provision provides examples of
approval categories, although these examples are not exhaustive. One example is
that there may be an approval category to allow prescribing of all forms,
strengths and quantities of certain controlled medicines (anticipated to include
more than morphine and oxycodone) for people with terminal illness.