Medicines, Poisons and Therapeutic Goods Amendment Regulation 2013 (No 2) (ACT)

Case

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2013 (No 2)

Subordinate Law SL2013-28

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

Dated 24 October 2013.

Katy Gallagher

Minister

Andrew Barr

Minister

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2013 (No 2)

Subordinate Law SL2013-28

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

Contents

Page

1            Name of regulation  1

2            Commencement  1

3            Legislation amended  1

4            New section 11 (2) (ea)  1

5            Section 31 (b) (ii)  1

6            New section 31 (b) (iia)  2

7           New section 31 (2)  2

8            New section 41 (2A)  2

9            New section 100 (ba)  3

10          Section 120 (3), definition of completed, new paragraph (c)                  3

11          Section 124 (2) (a)  3

12          Section 124 (3) (a)  3

13          New part 4.3A  4

14          Section 752  5

15          Section 752, new note  6

16          Section 863  6

17          Dictionary, note 2  7

18          Dictionary, new definitions  7

  1. Name of regulation

    This regulation is the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2013 (No 2).

  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 section 11 (2) (ea)

    insert

    (ea)section 255 (which is about authorisation of approved pharmacists to supply certain medicines without prescription);

  5. Section 31 (b) (ii)

    after 1st mention of

    prescription

    insert

    (other than a national residential medication chart prescription)

  1. New section 31 (b) (iia)

    insert

    (iia)if the prescription is a national residential medication chart prescription in a national residential medication chart––the chart includes the particulars mentioned in section 41; and

  2. New section 31 (2)

    insert

    (2)In this section:

    national residential medication chart means a residential medication chart within the meaning of the National Health (Pharmaceutical Benefits) Regulations 1960 (Cwlth), section 19AA (6) (Item in residential medication chart is prescription), as in force from time to time.

    NoteThe National Health (Pharmaceutical Benefits) Regulations 1960 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

  3. New section 41 (2A)

    after the notes, insert

    (2A)Also, if the prescription is a national residential medication chart prescription, the prescription need not include either of the following:

    (a)the prescriber’s professional qualifications;

    (b)the quantity of the medicine to be dispensed or administered under the prescription.

  4. New section 100 (ba)

    insert

    (ba)section 255 (which is about authorisation of approved pharmacists to supply certain medicines without prescription);

  5. Section 120 (3), definition of completed, new paragraph (c)

    insert

    (c)for a national residential medication chart prescription––the prescription is dispensed for the last time.

  6. Section 124 (2) (a)

    substitute

    (a)if the prescription is a single prescription, the last repeat of a repeat prescription, or a national residential medication chart prescription dispensed for the last time––the word ‘cancelled’ on the front of the prescription; and

  7. Section 124 (3) (a)

    substitute

    (a)if the prescription is a single prescription, the last repeat of a repeat prescription, or a national residential medication chart prescription dispensed for the last time––the word ‘cancelled’; and

  8. New part 4.3A

    insert

Part 4.3AAuthorisation to supply certain medicines without prescription—continued dispensing

  1. Authorisation to supply certain medicines without prescription by approved pharmacist––Act, s 185 (1) (g)

    An approved pharmacist is authorised to supply a medicine to a person without prescription if––

    (a)the medicine is listed as a pharmaceutical benefit under a continued dispensing determination; and

    (b)the pharmacist supplies the medicine to the person in accordance with the determination.

  2. Labelling certain medicines supplied without prescription by approved pharmacist––Act, s 185 (1) (j)

    The medicine supplied to a person under section 255 must have a label that includes the following:

    (a)the name of the person to whom the medicine is supplied;

    (b)the date the medicine is supplied;

    (c)the name, business address and telephone number of the pharmacy from which the medicine is supplied;

    (d)the initials or other identification of the pharmacist supplying the medicine;

    (e)the medicine’s approved name and brand name;

    NoteApproved name––see the medicines and poisons standard, par 1 (1).

    (f)the form, strength and quantity of the medicine;

    (g)if the package of the supplied medicine is not a manufacturer’s pack—the relevant expiry date for the medicine;

    (h)a number that is different from the number given to any prescription dispensed at the pharmacy;

    (i)directions about the use of the medicine that are adequate to allow the medicine to be taken or administered safely, including any warning statement in the medicines and poisons standard, appendix K (Drugs required to be labelled with a sedation warning) applying to the medicine;

    (j)words to the effect of ‘keep out of reach of children’.

    Example—pars (e) and (f)

    Microlut 28 tablets (Levonorgestrel)     30mcg    3

    NoteAn example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

  3. Section 752

    omit

    AS/NZS ISO 8124.3:2003 (Safety of toys – Migration of certain elements)

    substitute

    AS/NZS ISO 8124.3 (Safety of toys – Migration of certain elements)

  4. Section 752, new note

    insert

    NoteAS/NZS ISO 8124:3 does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863). The standard may be purchased at >

    Section 863

    substitute

  5. Disapplication of Legislation Act, s 47 (6)

    The Legislation Act, section 47 (6) does not apply to the following:

    (a)AS/NZS ISO 8124.3 (Safety of toys – Migration of certain elements);

    (b)the Optometry Endorsement Scheduled Medicines Registration Standard;

    (c)the National Health Act 1953 (Cwlth);

    (d)the National Health (Pharmaceutical Benefits) Regulations 1960 (Cwlth);

    (e)a continued dispensing determination.

    Note 1An instrument and a law of another jurisdiction mentioned in this section do not need to be notified under the Legislation Act because s 47 (6) does not apply (see Legislation Act, s 47 (7)).

    Note 2A reference to an Act includes a reference to the statutory instruments made or in force under the Act, including any regulation (see Legislation Act, s 104).

    Note 3AS/NZS ISO 8124.3 may be purchased at 4The Optometry Endorsement Scheduled Medicines Registration Standard is accessible at 5A law of another jurisdiction mentioned in this section is accessible at >

    Dictionary, note 2

    insert

    ·     AS/NZS (see s 164 (2))

  6. Dictionary, new definitions

    insert

    approved pharmacist––see the National Health Act 1953 (Cwlth), section 84 (1), as in force from time to time.

    NoteThe National Health Act 1953 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

    continued dispensing determination means a determination made by the Minister under the National Health Act 1953 (Cwlth), section 89A (When pharmaceutical benefits may be supplied by approved pharmacists without prescription), as in force from time to time, about the supply of a pharmaceutical benefit to a person by an approved pharmacist without a prescription.

    NoteSee the National Health (Continued Dispensing) Determination 2012 (Cwlth). The determination does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

    national residential medication chart prescription means a medication chart prescription within the meaning of the National Health (Pharmaceutical Benefits) Regulations 1960 (Cwlth), section 19AA (Item in residential medication chart is prescription), as in force from time to time.

    NoteThe National Health (Pharmaceutical Benefits) Regulations 1960 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

    pharmaceutical benefit—see the National Health Act 1953 (Cwlth), section 84 (1), as in force from time to time.

    NoteThe National Health Act 1953 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

Endnotes

  1. Notification

    Notified under the Legislation Act on 4 November 2013.

  2. Republications of amended laws

    For the latest republication of amended laws, see align="center">© Australian Capital Territory 2013

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