Issue 82 - July 2008
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

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• Medicines
     • News flash
     • Reminders
     • TGA news
• Foods
     • FSANZ update
• Cosmetics
• Association news
• International news
• Conferences and meetings
• RFA training courses

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The Therapeutic Goods Administration (TGA) Regulatory Reform for Complementary Medicines – Workshop held in Canberra on the 30th July aimed to give an overview of the direction the new government intends to take post Trans-Tasman. The CHC attended the Workshop – for a summary of the event, see the ASSOCIATION NEWS section of this newsletter or click here.

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Sugar cane wax alcohols
The TGA is conducting a targeted review of products (including labelling, packaging and supporting evidence for claims) containing sugar cane wax alcohols. This review was prompted due to some sponsors making claims for serious haematological conditions.

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Product recalls
On 3 July Clexane 80 mg and 100mg were issued a recall on four additional batches of the anticoagulant (blood-thinning) medicine which were found to contain the contaminant over-sulphated chondroitin sulphate (OSCS). This is in addition to seven batches of the product recalled previously on April 22nd, May 27th and June 17th. (Sponsor – Sanofi-aventis Australia) Read more …

Therapeutic goods (listing) notice
Arabinogalactan - Larix, is now permitted as an active ingredient in listed medicines provided it complies with the following requirements:
• it is derived from Larix occidentalis or Larix larcinia;
• the concentration of polysaccharides is greater than or equal to 85 percent; and
• the maximum recommended daily dose of the ingredient is not to exceed 15 grams.
Read more …

TGA eBusiness services (eBS)
The TGA is releasing an upgraded version of the Online Services Internet site that will replace the current multi-point access online interface (SIME). It amalgamates draft applications into the one ‘filterable’ view; facilitates their final submission to the TGA and provides easier access for sponsors seeking information about their entries on the ARTG and TGA approved terminology. Read more …

CMEC 66th meeting
The Complementary Medicines Evaluation Committee 66th Meeting on April 18, made the following recommendations to the TGA:
- Ligusticum lucidum is not suitable for use as an ingredient in Listed medicines.
- the current label warning statement for products containing from 50 to 200 mg vitamin B6 (pyridoxine, pyridoxal, pyridoxamine) per recommended daily dose be amended as follows: for single ingredient products: "WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible." For multi-ingredient products:
"WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6."
- the use of Caesalpinia sappan as an ingredient in Listed medicines should be limited to traditional preparations of the heartwood.
- only an essential oil preparation of the wood of Cedrus atlantica, when administered topically or via inhalation, is suitable for use in Listed medicines.
- the use of Selaginella tamariscina as an ingredient in Listed medicines should be limited to traditional preparations of the herb.
- the use of Psoralea corylifolia as an ingredient in Listed medicines should be limited to preparations of the fruit/seed containing less than 1.1 per cent psoralen per recommended daily dose. Also an advisory statement, informing consumers of the photosensitizing potential of psoralen, is recommended to be included on any product containing preparations of Psoralea corylifolia. Read more …

CMEC 67th meeting
The Complementary Medicines Evaluation Committee 67th Meeting on June 20, made the following recommendations to the TGA:
- only the stir-fried burs of Xanthium sibiricum and Xanthium strumarium, prepared according to the monograph for 'Fructus Xanthii (stir-baked)' in the Pharmacopoeia of the People's Republic of China (2005), are suitable for use as an active ingredient in Listed medicines, at a maximum recommended daily dose of 9 g.
- only preparations of the rhizome of Ligusticum wallichii are suitable for use as an ingredient in Listed medicines.
- only preparations of the root and rhizome of Ligusticum sinense are suitable for use as an ingredient in Listed medicines. Read more ...

Guidance on changes to ELF 3
Following the inclusion of a product as a Listed medicine in the ARTG, sponsors may wish to change certain details previously advised to the TGA. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry is necessary and the regulatory impact that making certain changes to currently Listed products may have.Read more ...

Required advisory statements for medicine labels - proposed changes
A consultation document is available to advise stakeholders of the proposed changes to the Required Advisory Statements for Medicine Labels dated April 2008 (RASML). These changes include pregnancy related advisory statements on aspirin containing products and a new advisory statement for anticholinergic products. Comment is requested by 31 July. Read more ...

Therapeutic excluded goods order No 1
The Therapeutic Goods Order No 1 was gazetted in June and outlines goods declared not to be therapeutic goods. A new category of product has been added – these were previously regulated as therapeutic goods and are now regulated as cosmetics: ‘Goods that are not therapeutic goods, with allowable limited therapeutic use when advertised, represented or presented for supply in a particular way’. Read more ...

Declaration of low volume low value turnover therapeutic goods
An application form is available for declaring products with turnover of low volume and low value for 07/08 and 08/09. Read more ...

2008/09 Fees
Annual charges invoices for the 2008/09 financial year should have been received by sponsors by July 11, 3 weeks earlier than in the previous year which allows sponsors more time to review all their ARTG listings. Sponsors will have more than two months to review the product range listed in the invoice and identify products which should be cancelled (where supply ceased before 1 July 2008) and products for which an LVLV exemption will be sought. The due date for payment of the invoice will be 1 October 2008. Read more ...

Recall coordinators' contact details (updated June 2008)

TGA business plan 2008-2009

Advice from TGA on Gardasil (Human papillomavirus vaccine)

TGA open day – 24 August

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FSANZ changes to food code
Amendment 100 was gazetted on 10 July 2008 in Australia and published in the New Zealand Gazette on the same day. The Applications and Proposal which is covered by Amendment 100 are:
• Application A592 - Food derived from Glyphosate-tolerant Soybean MON89788
• Application A606 - Asparaginase as a Processing Aid (Enzyme)
• Proposal P272 - Labelling Requirements for Food for Catering Purposes & Retail Sale
Read more ...

Amendment 99 was gazetted on 26 June 2008 in Australia and published in the New Zealand Gazette on the same day. The Proposal which is covered by Amendment 99 is:
• Proposal P1006 - Remove Commencement Provision for Certain Special Purpose Infant Formula
Read more ...

New head for FSANZ board
Philippa Smith AM, former Commonwealth Ombudsman, has been appointed the new Chair of the FSANZ Board and Dianne Yates a new Board member. Read more ...

Review of nutrition, health and related claims requested Australia New Zealand Food Ministerial Council has asked for a review of the proposed Nutrition, Health and Related Claim standard put forward by FSANZ under proposal P293.

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NICNAS Gazette
The Chemical Gazette is a monthly publication containing information regarding changes to NICNAS legislation, newly assessed chemicals and the Register of Industrial Chemical Introducers. It is published on the NICNAS website on the first Tuesday of each month.
Read more ...

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TGA Regulatory Reform Workshop - Canberra, July 08
The CHC attended the Regulatory Reform for Complementary Medicines Workshop on the 30th July 2008 in Canberra to get an overview of the direction the new government intends to take post Trans-Tasman. A copy of the TGA presentation will become available on the TGA website. Five areas identified for regulatory reform discussed at the workshop include:
1. Reducing regulatory burden:
• The addition of the European Pharmacopeia (EP) and the United States Pharmacopeia-National Formulary (USP) is moving ahead. It is anticipated that this will be amended in the Act this year.
• A revised tablets and capsules TGO is anticipated to be finalised by October 2008 (it is currently in the editorial phase).
• A revised Grouping TGO will permit small changes to be made to listed complementary medicine products.
• A new definition of a complementary medicine should have no impact on products currently on the market. It is anticipated that the amendment to the Act will occur by March/April 2009. ‘Essences’ (e.g. flower essences) were to be a component of the definition under TTH however may not be included with the amendment but may be considered at a later date following further consultation with industry.
• Guidelines around the changes to exporting requirements will be released for public consultation by October/November 2008.
• There will be further public consultation on GMP fees and charges later this year. It is anticipated that the pay per inspection visit per manufacturing site, rather than pay annual fees, should help in reducing the costs to companies.
2. Greater transparency:
• The list of herbal ingredients currently available for use in complementary medicines will be listed in the regulations for clarity.
• The TGA is reviewing the current administrative process for registrations of complementary medicines including meeting with a sponsor before submitting application to identify areas of concern.
3. Deferred legislative amendments:
• The Complementary Medicines Evaluation Committee (CMEC) to now include an expert in complementary medicine manufacture and an epidemiologist and the ability to establish expert working groups to advise them.
• Compositional guidelines are moving towards being more formalised; a compositional monograph.
• The current administration of the Low Volume Low Value fee will become a legislative change.
4. Enhanced post-market monitoring:
• The main changes relating to post-market monitoring will mean that product registration may be ‘suspended’ instead of ‘cancelled’ from the ARTG whilst a problem is being investigated. Currently, cancelling a listing on the ARTG is only available under legislation to the TGA.
5. Future directions:
• The Levels of Evidence to support indications and claims document will be reviewed and have legal underpinning.
• The TGA aims to conduct audits of clinical trials (most likely only 1-2 per cent of those being carried out).
• PILs (the so-called "white list" of ingredients permitted by New Zealand) – The status of this list was raised. These ingredients will not be automatically accepted by the TGA. Applications will need to be submitted as per current new substance applications. The TGA noted that the TTH evaluations (at various states of completion), although now dated, are publicly available and may be a basis for an application.

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Codex adopts 35 international food standards
Thirty-five new international food standards were adopted during the last session of the Codex Alimentarius Commission, including guidelines on the use of flavourings and gluten-free products. In the first recommendations on flavourings, Codex defined the term and advised that they be used minimally, and in regards to gluten-free products, the body dramatically reduced the approved level of gluten allowed. Read more ...

Colourings to come with a warning
The European Parliament has adopted a legislative package that will see products containing any of six artificial colours labelled with a health warning for children. Foods containing tartrazine (E102), quinoline yellow (E104), sunset yellow (E110), carmoisine (E122), ponceau 4R (E124) and allura red (E129), will have to be labelled "may have an adverse effect on activity and attention in children". Read more ...

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Natural Therapies & Natural Health Expo
August 21 – 22, Wharf 8, Sydney
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WFDSA World Congress XIII (World Federation of Direct Selling Associations)
October 8 – 10, Raffles City Convention Centre, Singapore
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Blackmores Research Symposium 08
October 10-11, Amora Hotel, Jamison Sydney Australia
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Natural Products Expo East
October 15 – 18, Boston Convention & Exhibition Centre, Boston USA
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Organic Products Expo – BioFach America
October16 –18, Boston Convention & Exhibition Centre, Boston USA
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CAMEXPO (The complementary, natural and integrated healthcare show)
October 25 – 26, Earls Court London
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Complementary Healthcare Council AGM
October 29 – Amora Jamison Hotel, Sydney
Further information - contact Madelyn on or phone 02 6260 4022

Complementary Healthcare Council Annual Industry Awards
October 30, Dockside Darling Harbour, Sydney
Further information - contact Madelyn on or phone 02 6260 4022

Natural Therapies & Natural Health Expo
October 30 – 31, Camberwell Centre, Melbourne
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ASMI Annual Conference & AGM
November 19, Australian Technology Park, Redfern Sydney
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Integrity in Advertising Therapeutic Goods to consumers
TGACC advertising training seminars 2008 schedule
Read more

TGA International Training Calendar
Available for staff of overseas government regulatory organisations only
Read more

GMP Management Course
ASMI in partnership with the Advanced Manufacturing Centre and the University of NSW has created a course on GMP management which culminates in a graduate certificate. This course is open to members and non-members of ASMI.
Read more

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Robert Forbes & Associates regularly conducts training courses for clients in our Glebe office meeting room. Courses are conducted with up to five people from only one client at a time. Courses can be tailored to suit your needs, based on your product types and to address any regulatory issues you may be facing.

Half day (4 hour) courses
   • Overview of the Food/therapeutic/cosmetic interface
   • Cosmetic regulation
   • Advertising code
   • Researching levels of evidence for product claims and indications
   • TGA online applications
   • Finished product specifications

Full day courses
   • Food Standards

Contact for more information.

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Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants
Phone: 61 2 96608027 - Fax: 612 96608106 Postal: PO Box 123, Annandale NSW 2038 AUSTRALIA
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Disclaimer: Whilst Robert Forbes & Associates has made every effort to be accurate, errors may appear and are inadvertent.