Issue 77 - February 2008
The Essential Technical & Regulatory E-News - Australian & International

Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

• RFA news
• Medicines
• TGA news
• Foods
• FSANZ update
• International news
• Conferences and meetings
• Industry classifieds

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Training Courses
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. This means that the course can look at highly confidential product issues that could not otherwise be discussed if a competitor company was also attending.
Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for detailed information about the course content and availability. Our most requested courses are:

Food/therapeutic/cosmetic overview4 hour
Food Standards CodeFull day
Cosmetic RegulationFull day
Advertising Code and Levels of EvidenceFull day
Complementary medicines
Preparing a listing application
Full day
Finished product specifications4 hour

COMET database
For companies marketing complementary medicines in New Zealand it is suggested that you continue to list your products on the COMET database. RFA can assist with listing your products on the database. Read more …

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Revised general requirements for tablets and capsules
TGO 56 (Therapeutic Goods Order No 56 General Standard for tablets, pills and capsules) specifies the current Australian general requirements for tablets and capsules. The Therapeutic Goods Committee has recommended that a draft new Therapeutic Goods Order should be released for stakeholder consultation - TGO 78 – Therapeutic Goods Order 78 General Requirements for tablets and capsules. TGO 78 (draft) incorporates an approximately two year transition period for products to comply with the revised requirements. Comment on TGO 78 (draft) is sought by Friday 7 March 2008. Read more …

Therapeutic Goods Order No 77 – Microbiological standards for medicines
Comments from stakeholders are being sought on the adoption of the draft Therapeutic Goods Order on microbiological standards for medicines. The closing date for comments is Friday 7 March 2008. Read more …

Development of a best practice guideline on non-reclosable packaging
The TGA invites submissions from interested parties that will help inform the development of a best practice guideline on non-reclosable packaging. The guideline is intended to assist sponsors of therapeutic goods improve the effectiveness of blister or foil strip packaging as a barrier to children and thereby reduce the potential for accidental childhood poisoning from medicines packaged in this way. The closing date for submissions is Friday 14 March 2008. Read more …

Guidance on the GMP clearance of overseas medicine manufacturers
A sponsor applying to the TGA for registration or listing of a therapeutic good manufactured outside Australia, must provide an acceptable form of evidence to show that the manufacture of the goods is of an acceptable standard. This is referred to as Good Manufacturing Practice (GMP) clearance of overseas manufacturers. This guidance document is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. Read more …

Intention to amend TGO 69 general requirements for labels for medicines
This notice advises of the intention to amend the definition of 'Required Advisory Statements for Medicine Labels' included in clause 2 'Interpretation' of TGO 69. The intended amendment will update the version of the publication to which the definition refers. The effect of the intended amendment to TGO 69 will be to give legislative force to those additions and other changes made to advisory statements included in RASML through Update 1 (June 2005) and Update 2 (April 2006). It is intended that an Order amending TGO 69 will be made in March 2008, with the Order commencing to have effect three months later. Read more …

Interaction between glucosamine and warfarin
The TGA has received 12 reports suggesting an interaction between warfarin and glucosamine. Most of the cases described changes in the international normalised ratio (INR) after patients previously stable on warfarin began taking glucosamine. The potentiating effect of glucosamine on warfarin activity has been highlighted in a report of 22 cases to the WHO Collaborating Centre for Drug Monitoring (which includes 9 of the Australian reports) and also by the UK's Medical and Healthcare products Regulatory Agency which described 7 cases of INR increases in patients commencing glucosamine when previously stable on warfarin. Patients taking warfarin should be advised to consider the potential for interactions with other medicines, including complementary medicines and herbal remedies. ADRAC recommends patients taking warfarin should have their INR assessed within a few days and no later than two weeks after commencing or changing the dose of a complementary medicine. Read more …

Therapeutic Goods Committee 31st meeting
The TGC 31st meeting was held on 29 November recommendations were made to the TGA in the following areas:
• Adoption of British Pharmacopoeia 2008
• Revision of Therapeutic Goods Order No 65 Child-resistant packaging for therapeutic goods (TGO 65)
• Development of a best practice guideline for non-reclosable forms of child-resistant packaging
• Update to edition of required advisory statements for medicine labels (RASML) referenced in Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)
• Labelling requirements for medicines - revision of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)
• Standards for tablets and capsules - Revision of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56)
• Microbiological standards for medicines
• Proposal to establish a subcommittee to advise on standards for biologicals
• Review of the Code of Practice for the Tamper-Evident Packaging (TEP) of therapeutic goods
• Transfer of packaging requirements from Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
• Proposal to establish a subcommittee to advise on packaging matters relating to therapeutic goods Read more …

European Union Guidelines – newly published Read more …

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Food derived from cloned animals and their offspring
Cloned animals and their products have been the subject of recent and increasing attention and discussion among government policymakers, research scientists, media and the general public in some countries. In January 2008 the US Food and Drug Administration (FDA) released its final risk assessment report and the European Food Safety Agency released for public comment a draft opinion that the meat and milk from cloned animals is safe.

In Australia and New Zealand, the cloning of livestock animals is still in the experimental stages and is restricted to small numbers of elite breeding stock, predominantly in dairy and beef cattle (less than 100 in Australia), and also in small numbers of sheep.

Food Standards Australia New Zealand (FSANZ) has liaised closely with Australian and New Zealand leading researchers and industry in the livestock cloning area for several years now. FSANZ has been informed by those researchers that cloned animals produced by them are currently confined to the research environment under a voluntary moratorium and do not enter the food chain. Read more ...

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US and China sign for food safety in exports
The US and China have signed agreements aimed at improving the safety of food following a spate of contamination cases involving Chinese exports. Under the agreement, Chinese food and ingredient producers will have to register with local authorities, who will in turn be required to share data with the Department of Health and Human Services. The Chinese government is pledging to adopt quality-assurance methods throughout the supply chain. Read more …

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Natural Products Expo West
March 13 – 16, 2008, Anaheim Convention Centre, Anaheim USA
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The 3rd International Congress of CM Research 2008
March 29 – 31, 2008, Sydney Convention Centre, Darling Harbour Sydney
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Nutracon Europe
June 14 – 15, One Whitehall Place, London UK
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Healthy Foods International
June 18 – 19, Dallas Convention Centre, Dallas, Texas USA
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Natural Products Expo Asia
June 26 – 28, 2008, Hong Kong Convention and Exhibition Centre, Hong Kong
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Organic Products Expo – BioFach America
September 26 – 29, 2008, Baltimore Convention Centre, Baltimore USA
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Natural Products Expo East
October 15 – 18, 2008, Boston Convention & Exhibition Centre, Boston USA
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Integrity in Advertising Therapeutic Goods to consumers
– TGACC advertising training seminars 2008 schedule

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TGA International Training Calendar
Available for staff of overseas government regulatory organisations only
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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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Technical & Regulatory Affairs Manager
• Our ‘Champion of Brand Integrity’
• $90 - $100k Package (neg)

A newly created and key role reporting directly to the Managing Director provides you with the opportunity to join a Sydney based Australian owned company and exclusive distributor of a range of herbal products, vitamins, minerals and other complementary health care products, which are sourced both locally and internationally.

You will be responsible for managing all technical and regulatory aspects for the range of products, which includes: working with the TGA and all relevant regulatory bodies and ongoing regular contact with our suppliers both nationally and internationally. You will be the protector and champion of brand integrity and as a key member of the management team, have input into product research and development.

To succeed in the role you will possess scientific and/or naturopathic qualifications and background, have a current and sound ‘hands on’ working knowledge of all aspects of Australian therapeutic legislation. With at least 5 -10 years experience working in the complementary medicines or allied health care arena, you will also be an effective communicator, with a keen eye for detail and excellent written skills.

Please forward your detailed resume by no later than Wednesday March 12, 2008 to the attention of Ann Cattelan, Director of HealthWorks Pty Ltd at This email address is being protected from spambots. You need JavaScript enabled to view it.. You will be contacted within one week of the application close off date.

If you have a listing you would like to run in the Industry classifieds section of this newsletter please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for details about cost, word count and deadlines.

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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
Office: 335 -341 Glebe Point Road (Entrance Ferry Rd - Level 1), Glebe SYDNEY, NSW AUSTRALIA

Copyright 2008 Robert Forbes & Associates Pty Ltd. All rights reserved.

Disclaimer: Whilst Robert Forbes & Associates has made every effort to be accurate, errors may appear and are inadvertent.


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