Issue 85 - October 2008
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

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

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Revolutionary online vitamin converter
Visit the new-look RFA website and be sure to take a look at our world-first online vitamin converter. This vitamin converter has been developed by RFA and will save you time and effort! You can enter the amount of a vitamin and it will convert to IU or you can enter sodium ascorbate amount and it will convert to the amount of ascorbic acid or thiamine nitrate to thiamine – the list goes on! See for yourself just how easy the RFA online converter is to use click here.

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Product recalls and adverse events
The Therapeutic Goods Administration is urgently investigating reports from Queensland Health of adverse events associated with the use of Peripherally Inserted Central Catheter (PICC) lines in Queensland. The TGA is also working with the sponsor of the Arrow brand catheter to ascertain whether their instructions for use and labelling provide adequate information to the user to minimise reoccurrence of the type of problem described in the reports.
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On 2 October Nutrex Research Lipo 6 liquid capsules (Batch 10001277, exp 09/10) were issued a Class II Recall due to some bottles of this product containing traces of yohimbine. (Sponsor – Export Corporation, trading as Nutrition Systems)
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On 15 September Blackmores Sustained Release C tablets, 200s (Aust L 119710, batches A7559-2, exp04/10; A7958-2, exp04/10; A7959-2, exp02/10) were issued a Class III Recall as some bottles containing Bio C Chewable tablets (500mg Vitamin C) have been labelled as Sustained Release C tablets (500mg Vitamin C). (Sponsor – Blackmores Ltd)
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In September a number of hot/cold gel packs were issued Class I Recalls due to the products containing the toxic substance ethylene glycol rather than the non-toxic ingredient propylene glycol. For list of products involved click here.

[Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]

TGO 77 – Microbiological standards for medicines
An on-line version of Therapeutic Goods Order No 77 Microbiological Standards for Medicines (TGO 77) is available as well as a guidance document, intended to provide a plain English explanation of various requirements of TGO 77 and their application, in order to assist sponsors with compliance.
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TGA online services
TGA Online Services will be unavailable to all users from COB 29 October 2008 to COB 4 November 2008 AEDT inclusive. The TGA is currently preparing the imminent release of an upgraded version of the Online Services Internet site the TGA eBusinessServices (eBS) which will replace the current, multi-point access, Online Services interface (SIME).
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Uniform recall procedure for therapeutic goods – updated contacts
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Client details form - updated
This form should be completed by each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details.
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Newly published European guidelines
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Draft standard for nutrition & health related claims due April 09
The FSANZ Board approved draft Standard 1.2.7 – Nutrition, Health and Related Claims arising from Proposal P293 in March 2008, this was subsequently notified to the Ministerial Council. Following the May 2008 Ministerial Council meeting, the Council decided that it would ask FSANZ to review the draft Standard and agreed to extend the time for FSANZ to complete the review until 8 April 2009. For the criteria for the review click here.  

Kirin milk tea made in China
Following Australian test results showing levels of melamine in Kirin milk tea, a withdrawal from sale of this product has commenced by importers and wholesalers.
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In addition, international media reports have raised concerns about melamine contamination of fruit and vegetables grown in China that have been exported to the world. At this stage FSANZ can find no evidence that fruit and vegetable imports are unsafe. Read more ...

Updated confectionary list of melamine contaminated products Read more ...

FSANZ invites public comment to changes to food laws
FSANZ released details of a proposed change to the Australia New Zealand Food Standards Code and invites interested parties to comment. The item under consideration is the exemption of an allergen warning for isinglass. The Brewers Association of New Zealand has requested that FSANZ grant an exemption for isinglass from the mandatory declaration requirements for allergens in beer and wine. Isinglass is a permitted processing aid commonly derived from dried swim bladders of certain tropical and subtropical fish for use as a clarifying/fining agent. FSANZ has concluded that isinglass-fined beer and wine does not raise any safety concerns for consumers allergic to fish or fish products. FSANZ therefore recommend exempting isinglass from allergen declaration provisions of the Food Standards Code when present in beer and wine.
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Amendment 102 & 103 gazetted
Amendment 102 was gazetted on 3 October 2008 in Australia. The proposal P1001 covered under the amendment assesses a range of proposed amendments to the Code, intended to correct minor errors, inconsistencies and ambiguities; amend food regulatory measures in the Australia New Zealand Food Standards Code (the Code) as a result of an internal FSANZ audit of editorial notes in the Code; and delete or amend food regulatory measures in the Code that are outdated or no longer necessary.
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Amendment 103 was gazetted on 9 October 2008 in Australia. The Applications and Proposals which are covered by Amendment 103 are: Application A540 - Steviol Glycosides as Intense Sweeteners; Application A589 - Food derived from Glufosinate Ammonium-tolerant Rice LLRICE62; Proposal P1001 - Omnibus VII (except for Item [35] which was gazetted as part of Amendment No 102); Proposal P1003 - Mandatory Iodine Fortification for Australia.
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ACCORD Cosmetic Conference – Friday 31 October, Sydney Harbour Marriott Hotel
The Conference Contemporary Cosmetic Regulatory Issues – meeting consumer expectations will focus on industry and regulator responses to cosmetic claims, organic and natural product claims and product safety issues.
The Conference will also look at recent and emerging changes to the regulatory landscape such as the new EU Cosmetics Regulation, the New Zealand Cosmetic Group Standard, reform priorities in Australia and also look at scientific issues around transdermal delivery, consumer product testing and implications for the ban on animal testing on Australian regulatory requirements. The program will end on a high note with a dynamic presentation on trends and insights into marketing to women.
The key note speaker is Dr Chris Flower, Director-General, CTPA UK who will talk about the CTPA’s work with the UK Advertising Standards Association (ASA) on creating a common understanding between industry and the regulator regarding claims management and substantiation. Other key speakers include senior members from the ACCC, NICNAS, Monash University and CTFA NZ.  Sponsorship opportunities are available.  Registration forms are out now and can be downloaded from the ACCORD website.

CHC Seminar – Thursday 30 October, Amora Jamison Hotel, Sydney
Registration is now open for the Complementary Healthcare Council’s latest seminar “Advertising Compliance – it’s easier than you think!” Designed by the complementary healthcare industry for the complementary healthcare industry; this seminar will assist with advertising compliance and give you the competitive advantage when it comes to getting your product to market.
Topics include: “the Therapeutic Goods Advertising Code (TGAC)”; The Complementary Healthcare Council’s Code of Practice”; “Clarification of Terms for Claims and Coded Indications”; “Assessing Evidence”; “Where to Find Suitable Evidence for Your Product”; “Product Formulation and Development”; and “Communicating to Healthcare Professionals – Rational, Emotional or Social drivers”.
With speakers from Grey Healthcare, TGA and industry consultants, this seminar is not to be missed!
Date: October 30th 2008
Venue: Amora Jamison Hotel, 11 Jamison Street Sydney
Time: 9am -4:30pm

CHC Industry Awards Dinner – Thursday 30 October, Dockside Darling Harbour, Sydney
Once a year industry assembles at the Complementary Healthcare Council Annual Industry Awards Dinner to recognise and award the industry's 'finest' for excellence and achievement.
Date: October 30th 2008
Venue: Dockside Darling Harbour, Sydney
Time: 7-11pm

For more information on either of these events, please contact Madelyn: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone 02 6260 4022

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World Self-Medication Industry Symposium on Self Care in Healthcare Systems & FIP-WSMI Symposium on Medicines – Traditional, Alternative & Complementary
November 7-9, Beijing, China
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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
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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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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 This email address is being protected from spambots. You need JavaScript enabled to view it. 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
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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