Issue 93 - July 2009
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

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• Medicines
     • TGA news
• Foods
     • FSANZ update
• Cosmetics
     • NICNAS news
• Association news
• Conferences and meetings
• RFA training courses

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TGA news

TGA fees and charges 2009-10
Changes to the TGA's fees and charges for the 2009-10 financial year have been implemented. Listing application fee for a complementary medicine product goes from $560 to $640 and the annual fee goes from $710 to $810.
Fees and charges ...
Notes accompanying fees and charges at 10 July ...
Explanatory note ...

CMEC meeting dates
The dates for the 2009 meetings of the CMEC have been changed:
•  The meeting that was to be held on 24 July 2009 has been cancelled.
•  The meeting that was to be held on 2 October 2009 has been rescheduled to 4 September 2009 (CMEC 73).
•  The 4 December 2009 meeting remains as originally scheduled (CMEC 74).
Read more ...

Required advisory statements for medicine labels - proposed update 5
There are proposed changes to the Required Advisory Statements for Medicine Labels (Edition 1, including update 4) dated September 2008 (RASML). Stakeholders are requested to review and comment on the proposed changes by 20 August 2009.
Read more ...

Australian regulatory guidelines for OTC medicines (ARGOM)
The TGA has begun a project which will review and amend the current Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM), published in 2003. This ARGOM-09 project will bring the ARGOM up to date to reflect the current TGA regulatory environment and business practices for OTC medicines.
The updated ARGOM will be drafted in liaison with industry stakeholders. ARGOM, 2003 will remain as the guidance document until it can be fully replaced by the updated ARGOM (2009), which is intended to be published by the end of 2009.
Read more ...
Amendment schedule ...

Uniform recall procedure for therapeutic goods – update co-ordinator details
Read more ...

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

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FSANZ (Food Standards Australia New Zealand) update

Cereal-based beverages including rice and oat drinks – fact sheet
A new fact sheet is available which covers; what are cereal based beverages and what are their purpose; is their nutritional compositional comparable to milk; why they are not suitable as a milk replacement for children under 5 years; why is a advisory statement required.
Read more ...

Board appointments 2009
Four new appointments and three reappointments to the FSANZ Board have been made. Ms Jenni Mack, Dr James Murray, Dr David Roberts and Associate Professor Winsome Parnell are new appointments to the Board. Professor Katrine Baghurst, Dr Michele Allan and Mr Peter Boyden have been reappointed for four years.
Read more ...

Policy guideline on infant formula products
The Food Regulation Standing Committee (FRSC) Working Group on the Regulation of Infant Formula Products has published a Policy Options Consultation Paper to inform the development of Policy Guidelines for the Regulation of Infant Formula Products. Submissions from interested parties on the Policy Options Consultation Paper close on 1 September 2009.
Read more ...

Proposal 1008 to amend the food code
Proposed changes include:
6.6 Standard 1.3.2 Vitamin and Minerals – definition of a claimable food to be reformatted.
6.10 Standard 1.4.4.Prohibited and Restricted Plants and Fungi – Ammi Visnaga entry to replace Ammi species entry.
6.11 Standard 1.5.1 Novel Foods – add clause 3 exclusive use of novel foods to the list in table of provisions.
6.16 Standard 2.6.3 Kava – amend the Standard to indicate that it only applies where Kava is permitted to be supplied and that other restrictions on supply take precedence over the Standard.
Read more ...

FSANZ invites comment on food safety regulations for seed sprout production
FSANZ invites comment on a proposal to develop measures to maximise seed sprouts safety. The proposal is considering the development of a food safety standard for the production of seed sprouts (eg. alfalfa, mung beans) for human consumption in Australia. Such a standard would be incorporated into the Australia New Zealand Food Standards Code. Submissions close Wednesday 26 August 2009.
Read more ...

Amendment 110 gazetted on 16 July 2009
The Applications under which these amendments were made are:
Application A577 – 'Calcium in Chewing Gum containing no more than 0.2% Residual Sugars'
Application A588 – 'Voluntary Addition of Fluoride to Packaged Water'
Read more ...

Nutrition claims for foods
FSANZ have produced a fact sheet on nutrition claims – what they are, what laws govern them, what the code says about nutrition claims and what the future holds.
Read more ...

New food labelling guide (ACCC)
An electronic version of the Food labelling guide is available to help businesses in the food and beverage industry meet their obligations under the Trade Practices Act 1974, by ensuring that their product labelling, packaging and advertising is accurate and is not likely to mislead consumers.
Read more ...

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New NICNAS fees
From 1 July 2009 an increase will apply to the NICNS New Chemicals fees and charges. The new schedule is now available on the NICNAS website.
Read more ...

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Complementary Healthcare Council of Australia (CHC)

The Complementary Healthcare Council (CHC) is concerned new mandatory requirements for unit pricing of complementary medicines may mislead consumers and affect the quality use of medicines. A new unit pricing code will apply to all complementary and over-the-counter medicines that are sold in grocery stores and supermarkets. "We do not believe it is appropriate for consumers to choose medicines based solely on price alone. There are various formulations of complementary medicines which have different therapeutic claims, dosages and ingredients; these are things to consider when selecting your complementary medicine" said CHC Executive Director, Dr Wendy Morrow.

The CHC considers that the new code, by emphasising price, may lead consumers to believe that a cheaper product is identical to another higher-priced product and will provide the same health benefits. “We strongly urge that the mandatory requirement for unit pricing of complementary and other medicines sold in these retail outlets be reconsidered, and listed as exempt within the code, to ensure appropriate consumer choice.”
Details of the unit pricing code ...

National Herbalists Association (NHAA)

NHAA 2009 seminar series
The changing face of herbal practice with Sue Evans
Canberra Sat 1 August
Hobart Sun 2 August
Perth Sat 15 August
Brisbane Sun 20 September
Sydney Sat 10 October

For more details see or phone (02) 8765 0071
NHAA 8 CPE points

Natural Products New Zealand (NPNZ)

2010 Natural Products Summit
Natural Products New Zealand has set the date for the 2010 Natural Products Summit. Mark April 22, 2010 in your diary now!

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Conferences and meetings

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

Natural Health Conference & Expo
September 2 – 4, AJC Convention Centre, Randwick, Sydney
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

Panacea 2010
February 3 – 5, 2010 World Trade Centre, Mumbai, Maharashtra, India
Read more

Biofach Germany
February 17 – 20, Exhibition Centre Nuremberg, Germany
Read more

Natural Products Expo West
March 11 – 14, 2010 Anaheim Convention Centre, California, USA
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
   • Medicines - advertising code
   • Medicines - product claims and indications
   • Listed complementary medicines - TGA eBS online applications
   • Medicines – the sponsor's finished product specifications

Full day course
   • 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

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