TGC meeting 36, 11 August 2010

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 36th Meeting held on 11 August 2010. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be available in the form of an edited Report following ratification of the Minutes by the Committee.

Minutes of the 35th meeting of the TGC

The Therapeutic Goods Committee (TGC) NOTES that:

1. The Resolutions and Minutes of the 35th Meeting of the TGC, held on 14 October 2009, were ratified out-of-session as a true and accurate record of that Meeting; and
2. The documents Summary of Key Resolutions and Information for Stakeholders – Report on Meeting were published on the TGA website in December 2009 respectively, in accordance with usual practice.

Proposed Amendments to Schedule 1 to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines

1. The Therapeutic Goods Committee (TGC) NOTES:
   1. the consultation with interested parties undertaken by the Therapeutic Goods Administration on the paper "Proposed amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80)";
   2. the proposals for amendment to TGO 80 that were included in the consultation paper;
   3. the responses provided by interested parties; and
   4. relevant information including toxicity, availability in the community, poisoning incidents, patient needs, and technical feasibility.
2. On the basis of the criteria described in section 4 to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80), the TGC RECOMMENDS that Schedule 1 to TGO 80 be amended in the following manner:
   1. Include, in Part 1 to Schedule 1, a class entry for ANGIOTENSIN II ANTAGONISTS, with the following substances given as examples:
      1. Candesartan,
      2. Eprosartan,
      3. Irbesartan,
      4. Losartan,
      5. Olmesartan,
      6. Telmisartan, and
      7. Valsartan;
   2. Include, in Part 1 to Schedule 1, the following additional examples of substances that are captured by classes already specified:

      Existing Class of Substance	Additional examples of substances to be included
      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 Rivaroxaban
      BETA BLOCKING AGENTS	Nebivolol
      ORAL BLOOD GLUCOSE LOWERING AGENTS	Sitagliptin

   3. Re-name the current class entry "BENZODIAZEPINE DERIVATIVES" included in Part 1 to Schedule 1 of TGO 80 as "BENZODIAZEPINE DERIVATIVES AND BENZODIAZEPINE RELATED DRUGS" and include the following substances as examples of additional substances now captured by this class:
      1. Zolpidem,
      2. Zopiclone, and
      3. Zaleplon;
   4. Include in Part 2 to Schedule 1 of TGO 80 the following new entries:
      1. Aliskiren,
      2. Ambrisentan,
      3. Azadirachta indica (Neem), in a preparation for human dermal use containing more than 1 per cent of cold pressed neem seed oil,
      4. Bosentan,
      5. Chloral hydrate,
      6. Cilostazol,
      7. Deferasirox,
      8. Ivabradine,
      9. Lanthanum,
      10. Lenalidomide,
      11. Sitaxentan, and
      12. Varenicline; and
   5. Replace the current entry for "METHYL SALICYLATE" included in Part 2 to Schedule 1 to TGO 80 with the following entry:
   6. "METHYL SALICYLATE, in a liquid preparation, containing 5 per cent or more of methyl salicylate".
3. The TGC RECOMMENDS that these amendments to TGO 80 be made at the earliest time, with a period of 12 months being permitted for compliance for all affected products.
4. The TGC:
   1. RECOMMENDS that the exemptions currently included under subsections 7(c), (d) and (g) of TGO 80, which apply respectively to semi-solid preparations for application to the skin or mucous membranes, liquid or semi-solid preparations intended for application to the eye, ear or mucous membranes, and liquid preparations in spray presentation, be retained in TGO 80 for the present time;
   2. REQUESTS that the TGA maintain a watching brief on the availability of suitable child-resistant packaging for these types of preparations and return the matter for further consideration by the TGC at an appropriate time; and
   3. RECOMMENDS that the following substances and types of preparations be considered in the next review of Schedule 1 to TGO 80:
      1. fluoride salts,
      2. mercurochrome/merbromin,
      3. podophyllum/podophyllotoxin,
      4. eucalyptus oil,
      5. melaleuca oil,
      6. camphor, and
      7. substances of high toxicity which may be included in topical preparations or preparations presented in small volume containers.

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Packaging of cough and cold medicines

1. The Therapeutic Goods Committee (TGC) NOTES:
   1. the actions taken by the Therapeutic Goods Administration (TGA) in 2008-2010 to review the safety and efficacy of cough and cold medicines used in the treatment of children;
   2. the consultation with interested parties undertaken by the TGA in October - December 2009 through the paper "Labelling and packaging of cough and cold medicines – proposed changes to requirements";
   3. the proposal included in the consultation paper that all over-the-counter cough and cold medicines should be marketed in containers with child-resistant closures;
   4. the responses provided by interested parties to that specific proposal;
   5. the actions taken by overseas regulatory authorities following similar reviews of medicines for the treatment of coughs and colds in children; and
   6. relevant information including toxicity, availability in the community, poisoning incidents, patient needs, and technical feasibility.
2. On the basis of the criteria described in section 4 to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80), the TGC RECOMMENDS that the following substances be added to Schedule 1 of TGO 80:
   1. Bromhexine,
   2. Dextromethorphan,
   3. Guaiphenesin (Guaifenesin),
   4. Ipecacuanha,
   5. Oxymetazoline,
   6. Pentoxyverine,
   7. Pholcodine,
   8. Senega, and
   9. Xylometazoline.
3. The TGC RECOMMENDS that these amendments to TGO 80 be made as soon as possible, but not later than 31 May 2012.

Proposed Therapeutic Goods Order for Heparin

1. The Therapeutic Goods Committee (TGC) NOTES:
   1. the rationale for development of a draft Therapeutic Goods Order to specify the required standard for heparin when present in therapeutic goods, and in particular the need to control the presence of the contaminant over-sulfated chondroitin sulphate (OSCS);
   2. the consultation with interested parties undertaken by the Therapeutic Goods Administration in September-October 2009 on the paper "Proposed New Therapeutic Goods Order: Standard for Heparin";
   3. the responses to the consultation provided by interested parties;
   4. the revised monographs for heparin sodium and heparin calcium contained in the United States Pharmacopeia which became official on 1 October 2009;
   5. the revised monographs of the European Pharmacopoeia for heparin sodium and heparin calcium which became official on 1 August 2010 and were also adopted into the British Pharmacopoeia on the same date; and
   6. that the heparin monographs contained the British Pharmacopoeia, the European Pharmacopoeia and the United States Pharmacopeia now adequately control for the presence of OSCS and related contaminants and do not need to be supplemented by a Therapeutic Goods Order containing additional requirements.
2. The TGC RECOMMENDS that progression of the proposed Therapeutic Goods Order intended to specify the required standard for heparin when present in therapeutic goods is no longer necessary.

Proposed Therapeutic Goods Order for human albumin

1. The Therapeutic Goods Committee (TGC) NOTES:
   1. the rationale for development of a draft Therapeutic Goods Order to specify the required standard for human albumin when present in therapeutic goods;
   2. the consultation with interested parties undertaken by the Therapeutic Goods Administration in September 2009; and
   3. the responses to the consultation provided by interested parties.
2. The TGC ADVISES that the monographs of the British Pharmacopoeia and the European Pharmacopoeia for human albumin specify the standard that should apply to human albumin when present in therapeutic goods supplied in Australia, and that the monograph of the United States Pharmacopeia is not an appropriate standard.
3. The TGC RECOMMENDS that:
   1. the draft Therapeutic Goods Order "Standard for human albumin" should be amended to reflect that personal importation of medicines containing human albumin would be subject to the Order;
   2. the Order should be finalised under section 10 of the Therapeutic Goods Act 1989; and
   3. the new Order should take effect from its date of entry onto the Federal Register of Legislative Instruments.

Proposed Therapeutic Goods Order for water for injection for parenteral medicines

1. The Therapeutic Goods Committee (TGC) NOTES:
   1. the rationale for development of a draft Therapeutic Goods Order to specify the required standard for water for injection for parenteral medicines;
   2. the consultation with interested parties undertaken by the Therapeutic Goods Administration in September 2009; and
   3. the responses to the consultation provided by interested parties.
2. The TGC ADVISES that the monographs of the British Pharmacopoeia and the European Pharmacopoeia for water for injection specify the standard that should apply to water for injection when present in parenteral medicines supplied in Australia, and that the monograph of the United States Pharmacopeia is not an appropriate standard.
3. The TGC RECOMMENDS that:
   1. the draft Therapeutic Goods Order "Standard for water for injection for parenteral medicines" should be finalised under section 10 of the Therapeutic Goods Act 1989; and
   2. the new Order should take effect from the its date of entry onto the Federal Register of Legislative Instruments.

Proposed Order under Section 3C(1) of the Therapeutic Goods Act 1989

1. The Therapeutic Goods Committee (TGC) NOTES:
   1. the rationale for development of a draft Order to exempt specified monographs of the United States Pharmacopeia from being a 'standard' under the Therapeutic Goods Act 1989 (the Act);
   2. the consultation with interested parties undertaken by the Therapeutic Goods Administration in September 2009; and
   3. the responses to the consultation provided by interested parties.
2. The TGC RECOMMENDS that:
   1. the monographs of the United States Pharmacopeia specified in the draft Order of September 2009 should be exempted from the definition of 'standard' under the Act;
   2. the draft "Order under section 3C(1)" that reflects the above should be finalised and adopted; and
   3. the new Order should take effect from its date of entry onto the Federal Register of Legislative Instruments.

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