Federal Register of Legislation - Australian Government

Primary content

Orders/Other as made
This order amends the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines to introduce new mandatory warning statements on the labels of medicines that contain neuromuscular blocking agents.
Administered by: Health
Registered 18 Jun 2018
Tabling HistoryDate
Tabled HR19-Jun-2018
Tabled Senate20-Jun-2018
Date of repeal 03 Jul 2018
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

 

 

 

 

Therapeutic Goods Order No. 91B - Therapeutic Goods Order No. 91 (Standard for labels of prescription and related medicines) Amendment Order 2018

I, LARRY KELLY, a delegate of the Minister for Health, make this order under section 10 of the Therapeutic Goods Act 1989.

 

Dated 15 June 2018

 

(signed by)

LARRY KELLY

Delegate of the Minister for Health


Contents

1             Name............................................................................................................................. 3

2             Commencement............................................................................................................. 3

3             Authority....................................................................................................................... 3

4             Schedules...................................................................................................................... 3

Schedule 1—Amendments                                                                                           4

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines      4

 


1        Name

This instrument is the Therapeutic Goods Order No. 91B - Therapeutic Goods Order No. 91 (Standard for labels of prescription and related medicines) Amendment Order 2018.

2        Commencement

This instrument commences on 2 July 2018.

3        Authority

This instrument is made under section 10 of the Therapeutic Goods Act 1989.

4        Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.


Schedule 1Amendments

  

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

1          Section 6       Interpretation

Insert:

neuromuscular blocking agent means, for the purposes of this Order, any of the ingredients (or salts thereof) specified in Schedule 3 to this Order;

 

2          After subsection 9(3)

Insert:

 

(3A) Where medicines are supplied as part of a composite pack, the names of each active ingredient, together with its quantity or proportion, must be provided separately in relation to each medicine’s formulation, on the main label of the composite pack.

 

3          Subsection 9(8)

Repeal the subsection, substitute:

(8)   For subsection 9(6), where medicines are supplied as part of a composite pack:

(a)     the total number of active ingredients in all of the medicines in the composite pack are to be counted; and

(b)     if the same active ingredient is contained in two or more medicines in the composite pack, each of those active ingredients is to be counted separately;

for the purposes of determining if subsection 9(6) applies to the composite pack; and

(c)     the required information under subsection 9(6) must be provided separately in relation to the formulation of each   medicine in the composite pack.

 

4          Before subsection 10(9)

Insert:

(8A) Neuromuscular blocking agent-containing medicines

In addition to the requirements of sections 8 and 9, and the requirements in subsections 10(3), (4), (5) and (15) as applicable, if a medicine contains a neuromuscular blocking agent, then:

(a)     the label on the primary pack must include the warning statement ‘Warning: Paralysing agent’ in black text on a fluorescent red or warm red background; and

(b)     the label on the container must include the warning statement ‘Warning: Paralysing agent’ in black text on a fluorescent red or warm red background, except:

(i)            where subsection 10(5) applies, in which case this warning statement may be shortened to ‘Warning: Paralyser’ or ‘Paralyser’; or

(ii)          where subsection 10(15) applies, in which case this warning statement must be on the label of each ampoule, and may be shortened to ‘Warning: Paralyser’ or ‘Paralyser’, and may be in any colour text with no background colour.

 

5          Title of Section 11(6)

Omit “inclusion”, substitute “Inclusion”.

 

6          After Schedule 2

Insert:

Schedule 3 – Specified neuromuscular blocking agents (or salts thereof)

alcuronium

atracurium 

cisatracurium 

dimethyltubocurarine

doxacurium

fazadinium

gallamine

hexafluronium

mivacurium

pancuronium 

pipecuronium

rocuronium

suxamethonium

tubocurarine

vecuronium