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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

Book pagination

1.1 Diclofenac

Part A: Amendments to the Poisons Standard referred to an expert advisory committee

1. Advisory Committee on Medicines Scheduling (ACMS #23)

1.1 Diclofenac

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedule 2 entry for diclofenac in the Poisons Standard to read as follows:

Schedule 2 - Amend Entry

DICLOFENAC when:

  1. in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac; or
  2. in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 2 per cent or less of diclofenac or for the treatment of solar keratosis; or
  3. in transdermal preparations for topical use containing 140 mg or less of diclofenac.
Implementation date: 1 October 2018
Reasons:

As no new evidence has been received to alter the interim decision for diclofenac, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.

Public submissions on the interim decision

No public submissions were received before the second closing date in response to an invitation published on 7 June 2018 under regulation 42ZCKP of the Regulations.

Interim decision

The interim decision for diclofenac was published on the TGA website on 7 June 2018 at Publication of interim decisions amending, or not amending, the current Poisons Standard, June 2018 - 1.1 Diclofenac.

Scheduling proposal

The pre-meeting scheduling proposal for diclofenac was published on the TGA website on 21 December 2017 at Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018.

Book pagination