Tasmanian Numbered Regulations

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POISONS LIST AMENDMENT ORDER (NO. 3) 2006 (S.R. 2006, NO. 30) - REG 5

Schedule 2 amended (Medicinal Poisons)
Schedule 2 to the Principal Order is amended as follows:
(a) by omitting item 2008 and substituting the following:

2008. 

Aspirin except –

 

(a) when included in Schedule 4 , 5 or 6 ; or

 

(b) in individually wrapped powders or sachets of granules each containing 650mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when –

 

(i) enclosed in a primary pack that contains not more than 12 such powders or sachets of granules; and

 

(ii) compliant with the Required Advisory Statements for Medicine Labels; or

 

(c) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when –

 

(i) packed in blister or strip-packaging or in a container with a child-resistant closure; and

 

(ii) in a primary pack of not more than 25 tablets or capsules, each containing 325mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500mg or less of aspirin; and

 

(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

 

(d) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when –

 

(i) packed in blister or strip-packaging or in a container with a child-resistant closure; and

 

(ii) in a primary pack containing not more than 100 tablets or capsules, each containing 100mg or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and

 

(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

(b) by omitting item 2054 and substituting the following:

2054. 

Fluorides for human use (except in preparations containing 15mg/kg or 15mg/L or less of fluoride ion) –

 

(a) as sodium fluoride, in preparations for ingestion containing 2.2mg or less of sodium fluoride per dosage unit; or

 

(b) in preparations for topical use containing 2.5% or less of fluoride ion except –

 

(i) pastes, powders or gels for the cleaning of teeth, included in Schedule 3 ; or

 

(ii) pastes, powders or gels for the cleaning of teeth, containing 1 000mg/kg or less of fluoride ion; or

 

(iii) other dental hygiene products that are therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure, when compliant with the Required Advisory Statements for Medicine Labels; or

 

(iv) other dental hygiene products, that are not therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure and labelled with warnings to the following effect:

 

(A)  Do not swallow;

 

(B)  Do not use [this product / name of product] in children 6 years of age or less.

(c) 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 4g 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 of not more than 25 dosage units; and

 

(iv) compliant with the Required Advisory Statements for Medicine Labels.

(d) by omitting item 2094 and substituting the following:

2094. 

Miconazole for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

(e) by omitting item 2104 and substituting the following:

2104. 

Paracetamol for therapeutic use except –

 

(a) when included in Schedule 4 ; or

 

(b) in individually wrapped powders or sachets of granules each containing 1 000mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents, when –

 

(i) enclosed in a primary pack containing not more than 12 such powders or sachets; and

 

(ii) compliant with the Required Advisory Statements for Medicine Labels; and

 

(iii) not labelled for the treatment of children 6 years of age or less; or

 

(c) in tablets or capsules each containing 500mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents, when –

 

(i) packed in blister or strip-packaging or in a container with a child-resistant closure; and

 

(ii) in a primary pack containing not more than 25 such tablets or capsules; and

 

(iii) compliant with the Required Advisory Statements for Medicine Labels; and

 

(iv) not labelled for the treatment of children 6 years of age or less.

(f) by omitting item 2111 and substituting the following:

2111. 

Phenylephrine except –

 

(a) when included in Schedule 4 ; or

 

(b) in oral preparations containing 50mg or less of phenylephrine per recommended daily dose in packs containing 250mg or less of phenylephrine; or

 

(c) in topical eye or nasal preparations containing 1% or less of phenylephrine.

(g) by omitting item 2124 and substituting the following:

2124. 

Pyrithione zinc for human therapeutic use, except –

 

(a) in semi-solid hair preparations; or

 

(b) in shampoos containing 2% or less of pyrithione zinc when compliant with the Required Advisory Statements for Medicine Labels.

(h) by omitting item 2127 and substituting the following:

2127. 

Silver for therapeutic use except –

 

(a) in chewing gum each containing 5% or less of silver per dosage unit when compliant with the Required Advisory Statements for Medicine Labels; or

 

(b) in solutions for human oral use containing 0.3% or less of silver when compliant with the Required Advisory Statements for Medicine Labels; or

 

(c) in other preparations containing 1% or less of silver.



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