Poisons List Amendment Order (No. 2) 2011 (TAS)

Poisons List Amendment Order (No. 2) 2011

I make the following order under section 15(1) of the Poisons Act 1971 .30 August 2011

MICHELLE O’BYRNE

Minister for Health

1Short titleThis order may be cited as the Poisons List Amendment Order (No. 2) 2011 . 2CommencementThis order takes effect on the day on which its making is notified in the Gazette. 3Principal OrderIn this order, the Poisons List Order 2001 is referred to as the Principal Order. 4Schedule 2 amended (Medicinal Poisons) Schedule 2 to the Principal Order is amended as follows: (a) by omitting item 2053 and substituting the following:

2053.	Fexofenadine in preparations for oral use except in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when –
(a) in a primary pack containing 10 dosage units or less; and
(b) labelled with a recommended daily dose not exceeding 120mg of fexofenadine.

(b) by omitting item 2068 and substituting the following:

2068.	Ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1 200mg or less of ibuprofen –
(a) in liquid preparations when sold in the manufacturer’s original pack containing 8g or less of ibuprofen; or
(b) in divided preparations, each containing 200mg or less of ibuprofen, in packs of not more than 100 dosage units, except when –
(i) present as the only therapeutically active constituent other than an effervescent agent; and
(ii) packed in blister or strip-packaging or in a container with a child-resistant closure; and
(iii) in a primary pack containing not more than 25 dosage units; and
(iv) not labelled for the treatment of children 6 years of age or less; and
(v) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

(c) by omitting item 2089 and substituting the following:

2089.  Mercurochrome in preparations for external use containing 2% or less of mercurochrome, except when included in Schedule 6 .

5Schedule 3 amended (Potent Substances) Schedule 3 to the Principal Order is amended by inserting after item 3059X the following item:

3059Z.  Paracetamol when combined with ibuprofen in a primary pack containing 30 dosage units or less.

6Schedule 4 amended (Restricted Substances) Schedule 4 to the Principal Order is amended as follows: (a) by inserting after item 40113 the following:

40113M.  Apixaban.

(b) by inserting after item 40243 the following:

40243M.  Canakinumab.

(c) by omitting item 40503 and substituting the following:

40503.	Dimethyl sulfoxide (excluding dimethyl sulfone) for therapeutic use, except –
(a) when included in Schedule 6 ; or
(b) in in-vitro test kits.

(d) by inserting after item 40554 the following:

40554M.  Eculizumab.

(e) by omitting item 40639 and substituting the following:

40639.	Fexofenadine except –
(a) when included in Schedule 2 ; or
(b) in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when –
(i) in a primary pack containing 10 dosage units or less; and
(ii) labelled with a recommended daily dose not exceeding 120mg of fexofenadine.

(f) by inserting after item 40642 the following:

40642F.  Fingolimod.

(g) by inserting after item 40894R the following:

40894V.  Mavacoxib.

(h) by omitting item 41158 and substituting the following:

41158.	Paracetamol –
(a) when combined with aspirin or salicylamide or any derivative of these substances, except when separately specified in these Schedules; or
(b) when combined with ibuprofen in a primary pack containing more than 30 dosage units; or
(c) in slow-release tablets or capsules containing more than 665mg of paracetamol; or
(d) in non-slow-release tablets or capsules containing more than 500mg of paracetamol; or
(e) in individually wrapped powders or sachets of granules each containing more than 1 000mg of paracetamol; or
(f) for injection.

(i) by inserting after item 41518 the following:

41518M.  Ticagrelor.

(j) by inserting after item 41536 the following:

41536E.  Toceranib.

(k) by inserting after item 41616 the following:

41616M.  Vernakalant.

7Schedule 5 amended (Domestic Poisons) Schedule 5 to the Principal Order is amended as follows: (a) by inserting after item 5033 the following:

5033M.  Bispyribac except in preparations containing 10% or less of bispyribac.

(b) by omitting item 5117M and substituting the following:

5117M.	Emodepside in preparations –
(a) for external treatment of animals containing 2.5% or less of emodepside; or
(b) for oral treatment of animals containing 30mg or less of emodepside per dosage unit.

8Schedule 6 amended (Agricultural and Industrial Poisons) Schedule 6 to the Principal Order is amended as follows: (a) by omitting item 6144 and substituting the following:

6144.	Dimethyl sulfoxide (excluding dimethyl sulfone) –
(a) when not for therapeutic use; or
(b) for the treatment of animals –
(i) when combined with no other therapeutic substance(s); or
(ii) in liquid preparations containing copper salicylate and 1% or less of methyl salicylate as the only other therapeutic substances; or
(iii) in clay poultices containing 2% or less of dimethyl sulfoxide.

(b) by inserting after item 6198 the following:

6198M.  Flumioxazin when contained in water-soluble bags individually packed in sealed sachets.

(c) by inserting after item 6347 the following:

6347E.  Proquinazid.

9Schedule 7 amended (Dangerous Poisons) Schedule 7 to the Principal Order is amended by omitting item 7117M from Part 1 and substituting:

7117M.  Flumioxazin except when included in Schedule 6 .

Displayed and numbered in accordance with the Rules Publication Act 1953.

Notified in the Gazette on 7 September 2011

This order is administered in the Department of Health and Human Services.

EXPLANATORY NOTE

(This note is not part of the order) This order amends the