1 Final decisions made pursuant to regulation 42ZCZR - proposals referred to the November 209 Advisory Committee on Medicines Schedule (ACMS #28)
Note
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1.5. Final decision in relation to Paracetamol (liquid formulations)
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to paracetamol (liquid formulations) as follows:
Schedule 3 - Amend Entry*
PARACETAMOL:
a. when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
b. in modified release tablets or capsules containing 665 mg or less paracetamol; or
c. in liquid preparations for oral use except when in Schedule 2.
*The proposed amended Schedule 3 entry for paracetamol as written includes the final decision[15] for modified paracetamol that will be implemented 1 June 2020.
Schedule 2 - Amend Entry
PARACETAMOL for therapeutic use:
a. in liquid preparations for oral use containing a maximum of 10 g of paracetamol per container; or
b. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
c. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
d. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
e. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
f. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
g. in other preparations except:
- when included in Schedule 3 or 4; or
- in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
- enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
- compliant with the requirements of the Required Advisory Statements for Medicine Labels,
- not labelled for the treatment of children 6 years of age or less, and
- not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
- in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
- packed in blister or strip packaging or in a container with a child-resistant closure,
- in a primary pack containing not more than 20 tablets or capsules,
- compliant with the requirements of the Required Advisory Statements for Medicine Labels,
- not labelled for the treatment of children 6 years of age or less, and
- not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.
Reasons for the final decision (including findings on material questions of fact)
I confirm the reasons for my final decision to schedule paracetamol in liquid preparations for oral use in Schedule 3 except when in Schedule 2 as liquid preparations for oral use containing a maximum of 10 g of paracetamol per container, are as detailed in my interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the two submissions received before the second closing date in response to the call for further submissions published on 6 February 2020 under regulation 42ZCZP of the Regulations. Though not material to my decision, both submissions supported the interim decision and I acknowledge the concerns also expressed regarding the ambiguity of the initial scheduling proposal.
Summary of public submissions on the interim decision
In response to the interim decision, two (2) submissions were received. Both submissions supported the interim decision.
The main points provided in support of the interim decision were:
- The scheduling proposal in the Delegate's interim decision takes into consideration the appropriate balance between patient access to medicines and safety.
- The Delegate's interim decision on paracetamol (liquid formulations) is supported to the extent that current marketed products will not be affected by the decision.
Additional comment:
- One submission expressed their disappointment with the wording of the initial scheduling proposal due to ambiguity in the scheduling amendment as proposed which included both a concentration cut-off (50 mg/mL) and two different weight cut-offs (5 g and 50 g).
Date of effect of the decision
1 June 2020