Therapeutic Goods Order No. 80a - Amendments to Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (Cth)

Therapeutic Goods Order No. 80A Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines

Therapeutic Goods Act 1989

I, JOHN SKERRITT, a delegate of the Minister for Health for the purposes of the exercise of the Minister’s powers under section 10 of the Therapeutic Goods Act 1989 (the Act) and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the Act, hereby AMEND Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines, made on 27 August 2008, in the manner set out in Schedules 1, 2 and 3.

Dated September 17 2012

(signed by)

JOHN SKERRITT

Delegate of the Minister for Health

1     Name of Order

This Order is the Therapeutic Goods Order No. 80A Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines.

2     Commencement

This Order commences on and from 1 October 2013.

Schedule 1  Amendments to Part 1 of Schedule 1 of TGO 80

This Schedule sets out the following amendments to Part 1 of Schedule 1 of Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80):

1. ADD a new class of substances to the table in Part 1: ‘ANGIOTENSIN II ANTAGONISTS’; and

   
   
   

   ADD the following examples for this class of substances in that table: ‘Candesartan’, ‘Eprosartan’, ‘Irbesartan’, ‘Losartan’, ‘Olmesartan’, ‘Telmisartan’ and ‘Valsartan’.

   
   
   

2. ADD the following examples under the following existing classes of substances in the table in Part 1:

Existing Class of Substance	Additional examples
ANTICHOLINERGICS	Solifenacin
ANTIDEPRESSANTS	Desvenlafaxine Duloxetine
ANTIEPILEPTICS	Lacosamide Zonisamide
ANTIHISTAMINES	Levocetirazine
ANTINEOPLASTIC AGENTS	Dasatinib Erlotinib Lapatinib Nilotinib Sorafenib Sunitinib
ANTI-PARKINSON DRUGS	Rotigotine
ANTIPSYCHOTICS	Paliperidone
ANTITHROMBOTIC AGENTS	Dabigatran Prasugrel Rivaroxaban
BETA  BLOCKING AGENTS	Nebivolol
ORAL BLOOD GLUCOSE LOWERING AGENTS	Sitagliptin

1. AMEND the reference in the table in Part 1 to ‘BENZODIAZEPINE DERIVATIVES’ to refer instead to ‘BENZODIAZEPINE DERIVATIVES and BENZODIAZEPINE RELATED DRUGS’; and

   
   
   

   ADD the following additional examples for this class of substance: ‘Zolpidem’, ‘Zopiclone’ and ‘Zaleplon’.

1. AMEND the reference in the table in Part 1 to ‘OPIOIDS, excluding pholcodine’ to refer instead to ‘OPIOIDS’.

Schedule 2  Amendments to Part 2 of Schedule 1 of TGO 80

This Schedule sets out the following amendments to Part 2 of Schedule 1 of TGO 80:

1. ADD the following entries:

   ALISKIREN.

   AMBRISENTAN.

   AZADIRACHTA INDICA (NEEM), in a preparation for human dermal use containing more than 1 per cent of cold pressed neem seed oil.

   BOSENTAN.

   BROMHEXINE.

   CARAPICHEA IPECACUANHA (IPECACUANHA).

   CHLORAL HYDRATE.

   CILOSTAZOL.

   DEFERASIROX.

   DEXTROMETHORPHAN.

   GUAIPHENESIN; GUAIFENESIN.

   IVABRADINE.

   LANTHANUM.

   LENALIDOMIDE.

   OXYMETAZOLINE.

   PENTOXYVERINE.

   PHOLCODINE.

   POLYGALA SENEGA (SENEGA).

   VARENICLINE.

   XYLOMETAZOLINE.

2. REPLACE the entry ‘METHYL SALICYLATE, in a liquid preparation containing 25 per cent or more of methyl salicylate’ with:

‘METHYL SALICYLATE, in a liquid preparation containing 5 per cent or more of methyl salicylate’.

Schedule 3  Amendments to Part 3 of Schedule 1 of TGO 80

This Schedule sets out the following amendments to Part 3 of Schedule 1 of TGO 80:

1. ADD the following entries:

   Aliskiren.

   Ambrisentan.

   ANGIOTENSIN II ANTAGONISTS

   Azadirachta indica (Neem), in a preparation for human dermal use containing more than 1 per cent of cold pressed neem seed oil.

   BENZODIAZEPINE RELATED DRUGS

   Bosentan.

   Bromhexine.

   Candesartan (Angiotensin II Antagonists).

   Carapichea ipecacuanha (Ipecacuanha).

   Chloral hydrate.

   Cilostazol.

   Dabigatran (Antithrombotic Agents).

   Dasatinib (Antineoplastic Agents).

   Deferasirox.

   Desvenlafaxine (Antidepressants).

   Dextromethorphan.

   Duloxetine (Antidepressants).

   Eprosartan (Angiotensin II Antagonists).

   Erlotinib (Antineoplastic Agents).

   Guaiphenesin; Guaifenesin.

   Irbesartan (Angiotensin II Antagonists).

   Ivabradine.

   Lacosamide (Antiepileptics).

   Lanthanum.

   Lapatinib (Antineoplastic Agents).

   Lenalidomide.

   Levocetirazine (Antihistamines).

   Losartan (Angiotensin II Antagonists).

   Nebivolol (Beta Blocking Agents).

   Nilotinib (Antineoplastic Agents).

   Olmesartan (Angiotensin II Antagonists).

   Oxymetazoline.

   Paliperidone (Antipsychotics).

   Pentoxyverine.

   Pholcodine.

   Polygala senega (Senega).

   Prasugrel (Antithrombotic Agents).

   Rivaroxaban (Antithrombotic Agents).

   Rotigotine (Anti-Parkinson Drugs).

   Sitagliptin (Oral Blood Glucose Lowering Agents).

   Solifenacin (Anticholinergics).

   Sorafenib (Antineoplastic Agents).

   Sunitinib (Antineoplastic Agents).

   Telmisartan (Angiotensin II Antagonists).

   Valsartan (Angiotensin II Antagonists).

   Varenicline.

   Xylometazoline.

   Zaleplon (Benzodiazepine Derivatives and Benzodiazepine Related Drugs).

   Zolpidem (Benzodiazepine Derivatives and Benzodiazepine Related Drugs).

   Zonisamide (Antiepileptics).

   Zopiclone (Benzodiazepine Derivatives and Benzodiazepine Related Drugs).

2. REPLACE the reference to ‘METHYL SALICYLATE, in a liquid preparation containing 25 per cent or more of methyl salicylate’ with:

‘METHYL SALICYLATE, in a liquid preparation containing 5 per cent or more of methyl salicylate’.

1. AMEND the reference to ‘OPIOIDS, excluding pholcodine’ to refer instead to ‘OPIOIDS’.