ACT Numbered Regulations - Explanatory Statements

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MEDICINES, POISONS AND THERAPEUTIC GOODS AMENDMENT REGULATION 2016 (NO 1) (NO 5 OF 2016)

Australian Capital Territory

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2016 (No 1)

Subordinate law SL2016–5

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 seeks to authorise pharmacists and intern pharmacists to administer vaccines without a prescription in accordance with a direction of the Chief Health Officer. A Chief Health Officer direction made by disallowable instrument will ensure that administering pharmacists will comply with minimum training standards, premises and record keeping requirements.

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 2016 (No 1).

Clause 2 Commencement

Pursuant to this provision, the Regulation is to commence the day after notification.
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 This Regulation will then be immediately repealed.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 New section 11 (1) (ea)
This clause allows for the inclusion of section 352 (which is about authorisation of pharmacists and intern pharmacists to administer vaccines without prescription) as a recognised medicines authorisation under this Regulation.

Clause 5 New section 352
This provision specifies that in accordance with a direction of the Chief Health Officer, pharmacists and intern pharmacists (under the direct supervision of an authorised pharmacist) are authorised to administer a vaccine to an adult without prescription. This clause also provides a definition of a vaccine, based upon the Standards for the Uniform Scheduling of Medicines and Poisons vaccine definition.