Issue 84 - September 2008
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

http://www.robert-forbes.com/

 


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

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RFA launches revolutionary on-line vitamin converter
Today the RFA team officially launches its new look website along with an innovative vitamin converter. This world-first on-line calculator 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 and vice versa 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 on-line calculator is to use click here
And while you are there have a tour of the rest of the RFA site, you will find updates on the latest regulatory news relating to the complementary and OTC medicine, cosmetic and food industries; a mineral equivalence chart; a chart detailing product claims and levels of evidence; and information on regulatory training courses which can be tailored to your needs. Visit the new RFA website

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The CRP (Complaints Resolution Panel) has recently issued a notice regarding the use of the term ‘clinically proven’ in advertising of therapeutic goods. Read more …

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Product recalls
On 28 August MD Lash Factor Eyelash Conditioner, Silver tube, 6 gm bottle (All batches) was issued a Class I Recall due to it containing a derivative of a prostaglandin cloprostenol. Prostaglandins are prescription only ingredients and as such the product can only be used under medical supervision. (Sponsor – Copper Care Pty Ltd) Read more …

On 2 September Thermoskin® hot/cold gel pack (blue); Small (20cm x 13cm), Medium (30cm x 13cm) and Large (37cm x 18cm); product codes - 86901, 86902 and 86903; were issued a Class I Recall due to the products containing the toxic substance ethylene glycol rather than the non-toxic ingredient propylene glycol. (Sponsor – United Pacific Industries Pty Ltd) Read more … and 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.]

Therapeutic Goods Order No 80
The Therapeutic Goods Order No 80 (Child-resistant packaging requirements for medicines) includes an amended provision which states that no regulatory requirement for child-resistant packaging is required on glucosamine products containing potassium.
Guidance document …

Enforcement guidelines
The Enforcement Guidelines describe and explain the enforcement provisions included in the Therapeutic Goods Act and are provided as a guide to how sanctions set out in the Act will be enforced, including the general principles of civil penalty proceedings as opposed to criminal prosecutions relating to breaches of the Act. Read more …

Regulatory reform for complementary medicines
Consultation with industry on regulatory reforms for the complementary medicines sector reached general agreement to progress the regulatory reforms proposed in key areas:
1. Legislative amendments including replacement of compositional guidelines with statutory monographs, regulation of homoeopathic and anthroposophic preparations and the expansion of CMEC to include expertise in the manufacture of complementary medicines and in epidemiology.
2. Opportunities for reducing regulatory burden including a revised TGO for tablets and for capsules which proposes a range of limits for the content of active ingredients depending on the nature and stability of the ingredient and the proposal to exempt the manufacture of starting materials for use in listed medicines from the requirement to be manufactured under GMP (where the sole therapeutic purpose of the material is as a starting material).
3. Increasing transparency and the access to information
4. Enhancements to post-market monitoring
5. Future directions including a proposal to provide legal underpinning to the "levels of evidence" guideline.
Read more …

Regulation of homoeopathic and anthroposophic medicines
In April 2003, the Expert Committee on Complementary Medicines recommended that homoeopathic and related medicines making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy. Since then widespread consultation has been carried out and submissions received from stakeholders to develop an appropriate framework for the regulation of homoeopathic and anthroposophic medicines. Consultation currently underway seeks feedback by October 1, 2008. Read more …

Guidance on product changes in ELF3
Factors such as product stability, manufacturer changes and developing marketing strategies may require changes to product details that were entered at the time of the product's inclusion in the ARTG. This guidance document has been developed to provide assistance to sponsors determining if a change to their ARTG entry for a particular product is necessary. It also details the regulatory impact that making certain changes to currently Listed products may have.
Read more …

Adoption of European Union guidelines in Australia
The following EU guidelines have been recommended for adoption by the TGA and are open for comment:
• Guideline on the need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications (Close date for comment: 8.10.08)
• Guideline on reporting the results of Population Pharmacokinetic Analysis (Close date for comment: 8.10.08)
• Annex 1 to Guideline on the Scientific Data Requirements for a Plasma Master file (PMF) Revision 1 (Close date for comment: 8.10.08)
Read more …

Medicines Evaluation Committee (MEC)
MEC provides independent scientific and policy advice on OTC medicines to the Minister and the Australian Government Department of Health and Ageing through the TGA. The TGA is seeking expressions of interest for a position on the MEC, for a person with experience and expertise in the field of consumer representation. Read more …

CMEC 67th meeting
CMEC recommends to the TGA that the following active ingredients are suitable for use in Listed medicines:
- 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), at a maximum recommended daily dose of 9 g.
- preparations of the rhizome of Ligusticum wallichii.
- preparations of the root and rhizome of Ligusticum sinense.
Read more …

CMEC 68th meeting
CMEC recommends to the TGA that the following active ingredients are suitable for use in Listed medicines:
- herbal preparations of the root, rhizome and/or stolons of Glycyrrhiza glabra and Glycyrrhiza uralensis, subject to labelling advising of the potential for adverse effects in at-risk individuals, with wording to the effect - "Contains liquorice. Not suitable for people with a history of high blood pressure, or who are pregnant, or have kidney disease".
- herbal preparations of the fruit resin of Daemonorops draco.
Also CMEC recommends that Listed medicines containing phytosterols require a label advisory statement with words to the effect - "There is no benefit from taking more than 3g/day of phytosterols from all sources" AND "Not suitable for pregnant or lactating women".
Read more …

Required advisory statements for medicine labels
Updated September
2008 Read more …

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Food surveillance news
The current issue includes: news on recent food survey reports conducted by ACT Health, Australian Quarantine and Inspection Service updates on border testing of imported seafood, food recall advertising survey, microbiological quality of kebabs in NSW, NZFSA management of tutu toxin in honey and research on key food label elements. Read more ...

Food standards news
Read more ...

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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.

www.accord.asn.au


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
Invitations have been sent out for the Complementary Healthcare Council Industry Awards Gala Dinner.
Once a year industry assembles at the Complementary Healthcare Council Annual Industry Awards Dinner - the premier function on the complementary healthcare calendar - 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 Please note: there are limited places available for these events.

www.chc.org.au

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WFDSA World Congress XIII (World Federation of Direct Selling Associations)
October 8 – 10, Raffles City Convention Centre, Singapore
Read more ...

Blackmores Research Symposium 08
October 10-11, Amora Hotel, Jamison Sydney Australia
Read more ...

Natural Products Expo East
October 15 – 18, Boston Convention & Exhibition Centre, Boston USA
Read more ...

Organic Products Expo – BioFach America
October16 –18, Boston Convention & Exhibition Centre, Boston USA
Read more ...

CAMEXPO (The complementary, natural and integrated healthcare show)
October 25 – 26, Earls Court London
Read more ...

Complementary Healthcare Council AGM
October 29 – Amora Jamison Hotel, Sydney
Further information - contact Madelyn on This email address is being protected from spambots. You need JavaScript enabled to view it. or phone 02 6260 4022

Complementary Healthcare Council Annual Industry Awards
October 30, Dockside Darling Harbour, Sydney
Further information - contact Madelyn on This email address is being protected from spambots. You need JavaScript enabled to view it. or phone 02 6260 4022

Natural Therapies & Natural Health Expo
October 30 – 31, Camberwell Centre, Melbourne
Read more ...

ASMI Annual Conference & AGM
November 19, Australian Technology Park, Redfern Sydney
Read more ...

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 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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