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Issue 88 - February 2009
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants


This issue of Current Affairs is proudly sponsored by
the Baker Dillon Group

The BAKER DILLON GROUP is an award-winning marketing and communications firm providing insightful thinking to transform company and product marketing into relevant brand experiences. Read more ...

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• RFA News
• Medicines
     • TGA news
• Foods
     • FSANZ update
• Association news
• Information on our Sponsor for this issue
• Conferences and meetings
• RFA training courses

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RFA news

How will new Therapeutic Goods Orders affect your product(s)
As you are aware, the TGA has recently released two new Therapeutic Goods Orders:
•    TGO 77 Microbiological Standards for Medicines
http://www.tga.gov.au/legis/tgo/tgo77.pdf become law from 1 Nov 2010; and
•    TGO 78 Standard for Tablets and Capsules
http://www.tga.gov.au/legis/tgo/tgo78guide.pdf become law from 1 Jan 2010.
The new Therapeutic Goods Orders contain changes in microbiological test parameters and active ingredient assay limits. This will affect a broad range of products including existing and proposed:
•    Listed oral dosage forms (tablets, capsules and powders etc);
•    Listed herbal teas; and
•    Listed medicines containing vitamins.
We recommend that sponsors proactively adopt the new Orders when developing future products. We also strongly recommend sponsors update their existing finished product specifications in line with the new requirements well before the Orders become mandatory.
Please contact RFA (This email address is being protected from spambots. You need JavaScript enabled to view it.) if you require assistance with amending your product specifications to comply with TGO 78 and TGO 77.

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TGA news

Draft guideline for levels and kinds of evidence for Listed medicines with indications and claims for weight loss
A new guideline has been developed to help sponsors determine the level and kind of evidence required to support indications and claims for weight loss. This will help ensure consistency in the type and level of evidence required to support indications and claims for weight loss in Listed medicines and give consumers confidence in the medicines they choose for self-care.
Read more ...

Draft compositional guidelines
A compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in Listed medicines (active or excipient). Compositional guidelines are required where there is no standard for the substance in the British Pharmacopoeia (BP). Currently there are three draft compositional guidelines open for comment:
-    Fish oil draft compositional guideline – comments close 12 August 09
-    Vegetable oil phytosterol esters compositional guideline – comments close 29 July 09
-    Dimethyl sulfone compositional guideline – comments close 22 July 09
Read more ...

European Union guidelines (updated)
EU guidelines recommended for adoption or non-adoption.
Read more ...

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FSANZ (Food Standards Australia New Zealand) update

Amendment No 106 gazetted
Amendment No 106 was gazetted on 12 February 2009 in Australia and published in the New Zealand Gazette on the same day. The Application under which these amendments are made was Application A1001 - Food derived from Insect-protected Corn Line MIR162.
Read more ...

US peanut butter and salmonella
The United States is reporting a large outbreak of Salmonella Typhimurium food-borne illness linked with the consumption of peanut butter and other peanut products. This outbreak is associated with peanut butter, peanut paste and other peanut products manufactured at the Peanut Corporation of America (PCA) in the United States. Currently 806 products are subject to a voluntary recall. FSANZ has worked with the United States Food and Drug Administration to identify potentially affected product in Australia - so far three products have been identified and action taken. FSANZ will continue to monitor the ongoing investigation.
Read more ...

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Association news from CHC (Complimentary Healthcare Australia)

2009 Sponsors' Obligation Conference - REGISTRATIONS NOW OPEN
25 - 26 March 2009
FourPoints Sheraton, Darling Harbour, Sydney
The Complementary Healthcare Council will be holding its national Sponsors' Obligation Conference from Wednesday 25th – Thursday 26th March 2009. The theme for the 2009 conference will be "Pharmacovigilance". The conference will be held at FourPoints Sheraton, Darling Harbour, Sydney.
A variety of national and international speakers will be presenting including Joanne Barnes, Lesley Braun and the TGA as well as an opening address by Honorable the Senator Jan McLucas.
For more information please contact Madelyn Bredhauer on 02 6260 4022 or This email address is being protected from spambots. You need JavaScript enabled to view it..


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Association news from NPNZ (Natural Products New Zealand)

2009 New Zealand Natural Products Industry Summit
The Summit will be held at the Novotel, Rotorua on April 2, 2009. The Annual Gala Dinner will follow.
In the current economic environment it is crucial to remember that there are opportunities that come from all challenges. It is a matter of getting creative in how you work with international markets, how you reach your customers and how you keep the cash-flow coming. The impressive line up of local and international experts will bring an outside perspective to your business and provide insights into doing business better in challenging markets and times. How bad is it really? International speakers will give you the real picture from a global perspective with case studies and valuable tips on succeeding in international markets. Marketing experts will share brand development strategies for ingredients and retail products and present successful marketing programmes case studies.
Speakers include:
Sheldon Baker, senior partner and principal of the Baker Dillon Group, a leading US natural products industry brand development, advertising and public relations firm. Baker will review key elements and opportunities for importing New Zealand products into the North American marketplace, as well discuss brand development and product distribution.
Ian Finch and Jennifer Lucas from James & Wells Intellectual Property discuss intellectual property protection and how it applies to your business. Why is it necessary to think about intellectual property, what sort of protection is available and what steps do you need to take to ensure you are in the best possible position?
Horst Feldhaeuser of the global intelligence company Synovate will provide an overview of the state of the nation looking at; the economy in general; NZ consumer confidence; CPI vs income vs disposable income; and changes in consumer behaviour. This presentation will consider how the current economic climate can be looked upon as a challenge and an opportunity for companies working in or supplying the retail sector and consumers.
For more information on the Summit contact This email address is being protected from spambots. You need JavaScript enabled to view it.


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Information on our sponsor

Perhaps it's not about our global prestige or having an award-winning portfolio in the dietary supplement industry that is most important to you. Of course they're good to have but it's really about the net results we've achieved for our clients. We have transformed growing companies into powerhouse brands. For example, when a client goes from $1.5 million US to $20 million US in a year or sales rise 10% or more in a down economy as a result of marketing consultation we've provided, it's a win-win for all.

Many firms say they're a "full service agency." At the Baker Dillon Group we lay claim to the term Total Involvement Marketing™. We actively listen and learn every aspect of your products, your brand, your business…and your dreams. We've built a different kind of agency that produces results that focus on our client's needs. And just because you may be located in another part of the world, doesn't mean we can't be there for you when you need us, 24/7. It's a whole different way of customer-focused marketing in a world that's rapidly changing and where the internet has made real-time communication a reality.

At the Baker Dillon Group, we've thrown out the old agency way of doing business. We've developed an experienced team of specialists in advertising, public relations, trade show promotion, collateral material and packaging, web site design, internet marketing to strategize, and share information and ideas. We also have the resources in the US to guide you through market research, product distribution, regulatory inquiries and scientific audits. In other words, we're focused on achieving superior results for you as our client. We invite you to visit our web site at www.BakerDillon.com and contact us.

Sheldon Baker, senior partner and principal of the Baker Dillon Group, will be one of the featured presenters at the New Zealand Natural Products Industry Summit 2009 on April 2, 2009. Read more...

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Conferences and meetings

Natural Products Expo West
March 5 – 8, Anaheim Convention Centre, Anaheim, CA, USA
Read more

2009 Sponsors' Obligation Conference – Pharmacovigilance
March 25 – 26, FourPoints Sheraton, Darling Harbour, Sydney
Contact Madelyn Bredhauer on 02 6260 4022 or This email address is being protected from spambots. You need JavaScript enabled to view it..

2009 New Zealand Natural Products Industry Summit
April 2, Rotorua, New Zealand
Read more

Natural & Organic Products Europe
April 5 - 6, Olympia, London
Read more

Vitafoods International
May 5 – 7, Geneva Palexpo, Switzerland
Read more

Natural Products Expo Asia
August 27 - 29, Hong Kong Convention and Exhibition Centre, Hong Kong
Read more

Organic Products Expo – BioFach America
September 24 – 26, Boston, (MA) USA
Read more

Natural Products Expo East
September 23 – 26, Boston Convention & Exhibition Centre, Boston, MA, USA
Read more

ASMI Annual Conference & AGM
November 12, Australian Technology Park, Redfern Sydney
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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RFA 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. 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

For more information visit the RFA website

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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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