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Issue 87 - January 2009
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

www.robert-forbes.com

Click here to view this newsletter in your web browser


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

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The RFA team would like to wish you a healthy and happy 2009!

NICNAS reporting services
Did you know RFA currently provides NICNAS annual reporting services. This service pack includes review and advice on the ingredients that require NICNAS reporting, tracking import amounts, preparation of Form 15 and additional exemption category applications and submission of end of year annual reports. For more information about this service or to find out more about your obligations as an importer or manufacturer of cosmetics please contact us.

Visit the RFA website for a full list of RFA services.

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Product recalls and adverse events
On 19 December Nyal Cold & Flu Fighter - 24 tablets (AUST L 146264) Nyal Cold & Flu Fighter Day and Night - 24 tablets (AUST L 146263), were issued a Class I recall due to the these products being associated with a small number of serious allergic reactions. (Sponsor – Valeant Pharmaceuticals Australasia Pty Ltd)
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Health alert notification...

[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.]

Intention to amend the definition of 'British Pharmacopoeia'
Notification of the intention to amend the definition of 'British Pharmacopoeia' to specify British Pharmacopoeia 2009 (BP 2009) as the edition in force has been issued, to come into effect 1 June 2009.
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Update on project to rationalise international GMP inspection activities
The TGA joined the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMEA) to conduct a pilot project designed to facilitate collaboration of inspections of active pharmaceutical ingredient (API) manufacturers in developing country locations. The project formally commenced in November 2008.
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Review of ARGOM-09
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 project will bring the ARGOM up to date to reflect the current TGA regulatory environment and business practices for Over-The-Counter (OTC) Medicines. Re-drafting and consultation of the ARGOM will occur from October 2008 to October 2009. It is intended that the updated ARGOM will be published by the end of 2009.
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Review of the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods
The TGA invites submissions from interested parties to help in a technical review of the document Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods. The closing date for submissions is Friday 6 February 2009.
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CMEC 69th meeting
Complementary Medicines Evaluation Committee (CMEC) 69th meeting ratified minutes included the following recommendations:
-    preparations of the root of Stemona sessilifolia and Stemona japonica, for oral administration, are suitable for use as ingredients in Listed medicines when prepared according to the methods described in the current edition of the Pharmacopoeia of the People's Republic of China, and subject to a recommended maximum daily dose of 9g equivalent dry root.
-    preparations of Dryopteris crassirhizoma are not suitable for use as ingredients in Listed medicines.
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CMEC 70th meeting
Complementary Medicines Evaluation Committee (CMEC) 70th meeting ratified minutes included the following recommendations:
-    unprocessed preparations of the fruit or seed, and processed preparations of the seed (as described in the current edition of the Pharmacopoeia of the People's Republic of China) of Quisqualis indica, remain suitable as ingredients in Listed medicines, subject to a maximum recommended daily dose equivalent to 12g of the dried fruit, and 9g of the dried seed.
-    Bovine Whey Immunoglobulin (BWI) is suitable for use as an active ingredient in Listed therapeutic medicines, where supported by appropriate evidence for any indications and claims made for the product.
-    the use of magnesium sulfate in medicines be referred to the National Drugs and poisons Schedule Committee (NDPSC) to consider if there should be restrictions on access to certain doses of magnesium sulfate.
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TGC 33rd meeting
The Therapeutic Goods Committee 33rd meeting report included the following items:
-    the Therapeutic Goods Administration is developing a Therapeutic Goods Order that references the United States Pharmacopeia test for "over-sulphated chondroitin sulphate" as the standard for all therapeutic goods that contain heparin (a 2 year sunset clause is proposed).
-    changes to the Therapeutic Goods Act 1989 to adopt the British Pharmacopoeia, the European Pharmacopoeia and United States Pharmacopeia-National Formulary are being prepared and implications discussed.
-    standards for anthroposophic and homoeopathic medicines are being discussed and in principle the TGC endorses the need for the Act to allow for appropriate specific default standards for these medicines.
-    stakeholder consultation on draft Therapeutic Goods Order No 79 General Requirements for the Labelling of Medicines is underway and it is proposed that some initiatives may be progressed as amendments to TGO 69 in the interim.
-    proposed update to the edition of Required Advisory Statements for Medicine Labels (RASML) referenced in Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines
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Therapeutic goods Listing notice 2008 (No 6)
The following therapeutic goods can now be included as Listed goods for oral use, on the Australian Register of Therapeutic Goods:
•    preparations containing dimethyl sulfone
•    preparations containing vegetable oil phytosterol esters, with the condition that the label must contain an advisory statement to the effect of: "There is no benefit from taking more than 3g/day of phytosterols from all sources"; and "Not suitable for pregnant or lactating women".
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Therapeutic goods Listing notice 2008 (No 5)
The following therapeutic goods can now be included as Listed goods for dental use only, on the Australian Register of Therapeutic Goods:
•    preparations containing potassium chloride, on condition the total potassium content in the product must not exceed an amount equivalent to a 3.75% concentration of potassium chloride, which will restrict the potassium ion in the product to 20 g/kg.
•    preparations containing potassium nitrate, on condition the total potassium content in the product must not exceed an amount equivalent to a 5% concentration of potassium nitrate, which will restrict the potassium ion in the product to 20 g/kg.
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Regulatory reform program
The Australian Government has agreed to implement a reform agenda to update and streamline the existing regulatory framework for therapeutic goods in Australia. This will focus on a wide range of regulatory reforms that were developed and consulted on as part of the legislation associated with the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA).
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Authorisation to cancel a product from the ARTG
A form to request cancellation of the registration/listing/inclusion of medicines and/or devices on the Australian Register of Therapeutic Goods is available in pdf or word format.
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European Union guidelines (updated)
EU guidelines recommended for adoption or non-adoption.
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Health claims delayed until a review of food labelling completed
In September 2008 the Ministerial Council extended the period for completing the First Review of Proposal P293 - Nutrition, Health & Related Claims until April 2009. However, at a October 2008 meeting, the Ministerial Council requested the notification of the First Review Report for Proposal P293 be deferred, so it could be considered concurrently with the outcomes of an independent Ministerial review of labelling law and policy being conducted in 2009. The Ministerial Council therefore agreed to extend the reporting timeframe for the First Review of Proposal P293 until March 2010.
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Options paper for special purpose foods
Comment from all interested persons on the "Food Regulation Policy Options Consultation Paper for Special Purpose Foods" is being sought.
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Australian children consume low levels of food colours
A survey released by FSANZ concluded that Australian children are consuming low levels of food colours, which FSANZ says may indicate that colours are not being used above maximum permitted levels, or at levels that would pose a risk to consumers.
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Update on safety of GM corn
The Austrian government commissioned scientists to conduct a detailed study into the long-term effects in mice continuously fed a diet containing GM corn. The recently released report of the study claims that a small effect on fertility was found. FSANZ scientists examined the report in detail and found numerous deficiencies in the experimental methods used and in the interpretation of results. In addition the European Food Safety Authority (EFSA) does not consider the Austrian studies to be of scientific value due to flaws in methodology, a number of statistical errors, and inconsistent evaluations of data.
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Lunch box food safety
The Food Safety Information Council has released an information sheet on how to minimise the risk of getting food poisoning from your lunch box.
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Approval sought for cholesterol-lowering food ingredient in fruit juice
Coca-Cola South Pacific Pty Ltd is seeking approval from FSANZ for the use of phytosterols derived from vegetable oils as a novel food ingredient in fruit juice and fruit juice drinks (minimum 20% juice) to a maximum level of 4.5 grams per litre. The products will be specifically marketed to adult consumers, generally over the age of 40, with concerns about their blood cholesterol level.
FSANZ has invited public comment, submissions close on February 11, 2009.
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Food Standards News ...

Food Surveillance News ...

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CHC Sponsors' Obligations Conference – PHARMACOVIGILANCE
25 - 26 March 2009
FourPoints Sheraton, Darling Harbour, Sydney
A variety of national and international speakers will be presenting including Prof Joanne Barnes, Lesley Braun and the TGA as well as an opening address by Senator Jan McLucas.
Email This email address is being protected from spambots. You need JavaScript enabled to view it. to register your interest.

CHC Seminar - HOW TO AUST R FOR COMPLEMENTARY MEDICINES
Wednesday 11 February
Sebel Albert Park, Melbourne 9:00am – 4:30pm
Avoid the pitfalls - get the tips on preparing an excellent registration application for you new product. If you are interested in registering your product or have ever been through the registration process, then this seminar is for you.
Our speakers will clarify the registration process and equip you with the knowledge and information you need to get your products through the registration process!
For more information please contact Madelyn our Events Coordinator: This email address is being protected from spambots. You need JavaScript enabled to view it.

www.chc.org.au

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Natural Products Expo West
March 5 – 8, Anaheim Convention Centre, Anaheim, CA, USA
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Vitafoods International
May 5 – 7, Geneva Palexpo, Switzerland
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Natural Products Expo Asia
August 27 - 29, Hong Kong Convention and Exhibition Centre, Hong Kong
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Organic Products Expo – BioFach America
September 24 – 26, Boston, (MA) USA
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Natural Products Expo East
September 23 – 26, Boston Convention & Exhibition Centre, Boston, MA, USA
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ASMI Annual Conference & AGM
November 12, Australian Technology Park, Redfern Sydney
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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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