1Short titleThis regulation may be cited as the Medicines and Poisons (Medicines) Amendment Regulation (No. 2) 2023.2CommencementThis regulation commences on 1 July 2023.3Regulation amendedThis regulation amends the Medicines and Poisons (Medicines) Regulation 2021.4Insertion of new s 6AAfter section 6—insert—6AExemption for S3 naloxone treatment programs—Act, s 7(1)For section 7(1) of the Act, each of the following activities with the following substances is prescribed—

(a)supplying, by wholesale, stock of S3 naloxone for a naloxone treatment program;

(b)giving 1 or more doses of S3 naloxone obtained under a naloxone treatment program to a person;

(c)administering S3 naloxone obtained under a naloxone treatment program to a person.

(2)However, subsection (3) applies to an activity mentioned in subsection (1)(b) carried out by a person performing a function under a naloxone treatment program.(3)The activity is prescribed only to the extent—

(a)the person is appropriately qualified; and

(b)the person, when carrying out the activity, gives instructions about—

(i)how to recognise signs and symptoms of suspected opioid overdose; and

(ii)how to administer the S3 naloxone.

(4)In this section—naloxone treatment program means a program set up by an entity of the State or Commonwealth to make S3 naloxone widely available for treating opioid overdose.S3 naloxone means naloxone in a manufacturer’s pack for the treatment of opioid overdose, other than naloxone that is an S4 medicine.5Amendment of s 161 (Selling S3 medicine with instructions for use)Section 161(3), example, from ‘naloxone’—omit, insert—an adrenaline (epinephrine) autoinjector to treat an anaphylactic reaction.6Amendment of sch 1 (Extended practice authorities and departmental standards)(1)Schedule 1, part 1, entry for Registered nurses, ‘2’—omit, insert—3(2)Schedule 1, part 2, entry for Secure storage of S8 medicines, ‘1’—omit, insert—27Amendment of sch 2 (Categories of medicines)Schedule 2, part 1, division 1—insert—

alefacept

follitropin delta

MDMA

psilocybine

sitaxentan

8Amendment of sch 6 (Medical practitioners and assistants)(1)Schedule 6, section 20, items 1 to 4, ‘macitentan or riociguat’—omit, insert—macitentan, riociguat or sitaxentan(2)Schedule 6, section 22, items 1 to 4, before ‘bexarotene’—insert—alefacept,(3)Schedule 6, section 26, items 1 to 4, before ‘luteinising hormone’—insert—follitropin delta,(4)Schedule 6, section 30, items 1 to 4, before ‘luteinising hormone’—insert—follitropin delta,(5)Schedule 6, section 50, items 1, 4 and 5, ‘clozapine’—omit, insert—clozapine, MDMA or psilocybine(6)Schedule 6, section 50, item 6, ‘clozapine, amfetamine or methylphenidate’—omit, insert—a medicine mentioned in this column(7)Schedule 6, section 52, items 1 to 4, ‘riociguat’—omit, insert—riociguat, sitaxentan(8)Schedule 6, section 54, items 1 to 4, ‘riociguat’—omit, insert—riociguat, sitaxentan(9)Schedule 6, section 58, items 1 to 4, before ‘teriparatide’—insert—sitaxentan,9Amendment of sch 12 (Other health practitioners)Schedule 12, section 12, ‘Public Service Act 2008, section 24’—omit, insert—Public Sector Act 2022, section 27610Amendment of sch 22 (Dictionary)Schedule 22—insert—MDMA means the substance N, α-dimethyl-3,4-(methylenedioxy)phenylethylamine.