MCC 63: Harmonisation of the New Zealand and Australian
schedules
8
Harmonisation of the New Zealand and Australian schedules
8.1
out of
e
scope
8.1.1
out of
scope
8.1.2
out of scope
8.1.3
out of
scope
8.1.4
out of scope
8.1.5
out of
scope
8.1.6
out of scope
out of scope
8.1.7
out of scope
8.1.8
out of scope
8.2
Decisions by the Secretary to the Department of Health and Aging in
Australia (or the Secretary’s Delegate)
8.2.1
Decisions by the Delegate – 6 June 2019
TGA extract
3_TGAfinal-decisions-
matters-referred-marc
8.2.1.a Alkyl nitrites
A new group entry for alkyl nitrites was created in Schedule 4 (prescription)
except when specified elsewhere in the schedules.
The Schedule 4 (prescription) entry for amyl nitrite was down-scheduled to
Schedule 3 (Restricted) when in preparations for human therapeutic use and
packaged in containers with child-resistant closures.
The Schedule 4 (prescription) entries for isoamyl nitrite, butyl nitrite, isobutyl
nitrite and octyl nitrite remained unchanged.
New Schedule 10 (prohibited) entries were created for isopropyl nitrite and n-
propyl nitrite.
The implementation date for the delegate’s decision is 1 February 2020, in
view of the fact that there are new Schedule 10 entries and the incorporation
of a group alkyl nitrite entry in Schedule 4 which captures previously
unscheduled substances.
Schedule 1 of the Medicines Regulations currently does not contain a group
entry for alkyl nitrites.
Amyl nitrite is currently classified as a prescription medicine except when sold
to a person who holds a control ed substances licence (issued under section
95B of the Hazardous Substances and New Organisms Act 1996) authorising
the person to possess cyanide; except when sold to an exempt laboratory
covered by a Hazardous Substances and New Organisms Act 1996 approved
code of practice.
Isoamyl nitrite, butyl nitrite, isobutyl nitrite and octyl nitrite are currently
classified as prescription medicines.
Potential impact on products in the New Zealand market:
There are no products currently approved or pending containing these
specified substances.