Poisons and Therapeutic Goods Amendment (Methadone and Buprenorphine) Regulation 2006 (NSW)

2006 No 368

New South Wales

Poisons and Therapeutic Goods

Amendment (Methadone and

Buprenorphine) Regulation 2006

under the

Poisons and Therapeutic Goods Act 1966

Her Excellency the Governor, with the advice of the Executive Council, has made the following Regulation under the Poisons and Therapeutic Goods Act 1966.

JOHN HATZISTERGOS, M.L.C.,

Minister for Health

Explanatory note
Methadone and buprenorphine are classified as drugs of addiction under the Poisons and Therapeutic Goods Act 1966, because they are specified in Schedule Eight of the Poisons List proclaimed under that Act.
At present, a person may be licensed by the Director-General of the Department of Health to supply methadone and buprenorphine or other drugs of addiction (see Division 3 of Part 8 of the Poisons and Therapeutic Goods Regulation 2002).
The object of this Regulation is to provide that, after this Regulation commences, no further licences may be issued for the supply of methadone or buprenorphine to drug dependent persons under the New South Wales Opioid Treatment Program. This change will not affect the validity or operation of existing licences, and provision is made for the issue of replacement licences if there is a change of ownership of licensed premises.

This Regulation is made under the Poisons and Therapeutic Goods Act 1966, including section 45C (the general regulation-making power).

Published in Gazette No 84 of 30 June 2006, page 4853	Page 1
2006 No 368	Poisons and Therapeutic Goods Amendment (Methadone and
Clause 1	Buprenorphine) Regulation 2006

Poisons and Therapeutic Goods Amendment

(Methadone and Buprenorphine) Regulation 2006

under the

Poisons and Therapeutic Goods Act 1966

1      Name of Regulation

This Regulation is the Poisons and Therapeutic Goods Amendment
(Methadone and Buprenorphine) Regulation 2006.

2 Amendment of Poisons and Therapeutic Goods Regulation 2002

The Poisons and Therapeutic Goods Regulation 2002 is amended as set out in Schedule 1.

Poisons and Therapeutic Goods Amendment (Methadone and	2006 No 368
Buprenorphine) Regulation 2006
Amendment	Schedule 1
Schedule 1	Amendment

(Clause 2)

[1]      Clause 162 Consideration of applications

Insert after clause 162 (3):

(3A) On and from the commencement of this subclause, the Director-General is not empowered to issue a licence under this Division for the supply, under the program known as the New South Wales Opioid Treatment Program, of methadone or buprenorphine to drug dependent persons (as defined in section 27 of the Act) unless it is a replacement licence.

(3B)

To avoid doubt:

(a)	subclause (3A) does not affect the validity or operation of any licence to supply methadone or buprenorphine that was in force immediately before the commencement of that subclause, and
(b)	the Director-General may, after the commencement of subclause (3A):

(i)      add conditions to, or vary or revoke the conditions of, such a licence, or

(ii)      vary the premises to which such a licence relates, on the application of the licensee, and

(c) the Director-General must refuse any application for the issue of a licence referred to in subclause (3A) made, but not finally determined, before the commencement of that subclause.

[2]      Clause 162 (5)

Insert after clause 162 (4):

(5) In this clause:
replacement licence means a licence to supply methadone or
buprenorphine from premises from which a person was
previously licensed under this Division to supply methadone or
buprenorphine.

BY AUTHORITY