Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1) (ACT)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1)

Subordinate Law SL2021-19

The Australian Capital Territory Executive makes the following regulation under the Medicines, Poisons and Therapeutic Goods Act 2008.

Dated 17 August 2021.

Andrew Barr

Chief Minister

Rachel Stephen-Smith

Minister

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1)

Subordinate Law SL2021-19

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

1. Name of regulation

   This regulation is the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1).

2. Commencement

   This regulation commences on the day after its notification day.

   NoteThe naming and commencement provisions automatically commence on the notification day (see Legislation Act, s 75 (1)).

3. Legislation amended

   This regulation amends the Medicines, Poisons and Therapeutic Goods Regulation 2008.

4. New part 9.7

   insert

Part 9.7Authorisations for dealing with COVID‑19 vaccines

1. Authorisation for dealing with COVID-19 vaccine during public health emergency—Act, s 20 (1) (c)

   (1)A person is authorised to deal with a COVID-19 vaccine if—

   (a)the person is approved under this section to deal with a COVID‑19 vaccine; and

   (b)the dealing is consistent with any condition mentioned in the approval for the dealing of a COVID‑19 vaccine; and

   (c)for the supply of a COVID‑19 vaccine to another person—the other person is authorised to possess a COVID-19 vaccine.

   (2)The chief health officer may approve a person to deal with a COVID‑19 vaccine—

   (a) if the chief health officer is satisfied that the person is suitable to deal with a COVID-19 vaccine; and

   (b)subject to any conditions the chief health officer considers appropriate.

   Examples—par (a)

   ·     health practitioner not already authorised under sch 1

   ·     non-registered health practitioner

   ·     student of a health profession

   ·     Australian Defence Force medical technician

   NotePower to make an approval includes power to make different provision in relation to different matters or different classes of matters  and to make an approval that applies differently by reference to stated exceptions or factors (see Legislation Act, s 48).

   (3)An approval is a notifiable instrument.

   (4)Nothing in this section affects an authorisation of a person otherwise under the Act to deal with a COVID-19 vaccine.

   (5)In this section:

   COVID-19 means the coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2.

   COVID-19 emergency means—

   (a)a state of emergency declared under the Emergencies Act 2004, section 156 because of COVID-19; or

   (b)an emergency declared under the Public Health Act 1997, section 119 (including any extension or further extension) because of COVID-19.

   COVID-19 vaccine means SARS-COV-2 (COVID-19) vaccine listed in the medicines and poisons standard, schedule 4.

   deal, with a COVID-19 vaccine, means—

   (a)administer a COVID-19 vaccine; or

   (b)obtain a COVID-19 vaccine; or

   (c)possess a COVID-19 vaccine; or

   (d)supply a COVID-19 vaccine.

2. Expiry—pt 9.7

   (1)This part expires at the end of a 12-month period during which no COVID-19 emergency has been in force.

   (2)In this section:

   COVID-19 emergency—see section 491 (5).

Endnotes

1. Notification

   Notified under the Legislation Act on 17 August 2021.

2. Republications of amended laws

   For the latest republication of amended laws, see align="center">© Australian Capital Territory 2021