Technical Alerts

The Quarantine Fees and Charging Guidelines (incorporating relevant Imported Food fees) have been revised and a
final draft is attached  for comment. Comments can be sent to the Regulatory Affairs team at technical@chc.org.au
 by COB Friday 3rd February 2012.

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As advised in this months Technical Update, the OCM has made available a draft internal guidance document and
internal evaluation form relevant to the assessment of Active Herbal Extract Applications.

The Office of Complementary Medicines has been working to update the botanical names of a number of herbal
ingredients available for use in Listed medicines on the Australian Register of Therapeutic Goods (ARTG). This work
has largely been undertaken with industry via the Office of Complimentary Medicines / Industry Consultation Group.

Sponsors of affected medicines will soon be contacted by the OCM with further information.

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The OCM added the term “Multiple Sclerosis” to the list of Prohibited and Restricted words
contained within the validation rules of the Electronic Listing Facility (ELF). To assist members the CHC has
attached a comprehensive list of words that are Prohibited or Restricted in the ELF.

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Please note,  the OCM have made corrections to the Electronic Listing Facility with regard to Aconitum spp.

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The National Health and Medical Research Council (NHMRC) have released the draft Australian Dietary
Guidelines for public consultation. And the Department of Health and Ageing, in consultation with the New Zealand
Ministry of Health, has engaged Nous Group and Baker IDI to investigate the validity and scope for undertaking a
review of NRVs for Australia and New Zealand. A summary of findings from recent stakeholder consultation is
provided.

To read more click here.

Australian and New Zealand ministers responsible for the regulation of food met in Melbourne on 9th
December 2011 to consider their response to the recommendations in the Blewett Report, Labelling
Logic.

A summary of the main recommendations are outlined, including detail on recommendation 23:-That a consistent,
seamless regulatory approach for nutrition, health and related claims be adopted for food, complementary
medicines and dietary supplements.

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The NZ Natural Health Products Bill received support from both sides of the House after its first
reading in Parliament recently. The NZ Natural Health Products Bill is intended to regulate
“therapeutic type dietary supplements” (as opposed to food-type, which are now covered by a Food
Standard).

The main reforms under the Bill include....

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The Parliamentary Secretary for Health and Ageing, the Hon. Catherine King MP, yesterday released the
report entitled TGA reforms: A blueprint for TGA’s future, a comprehensive package of reforms for TGA to
ensure the regulation of medicines and medical devices is more effective and transparent.

In response to the release the CHC welcomed the announcement, noting the real test will be in the
implementation of the recommendations.

A summary of the main points outlined in the ‘blueprint’ are provided below. The full report has also been
attached.

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IADSA recently provided the CHC with EU Food Supplement Alerts covering data on food and food supplements
over a 6 month period (May-August 2011). A summary of this data, provided by the Council of Responsible Nutrition
in the UK, is available at....

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