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Current Affairs
Issue 105 - March-April 2011 Published by Robert Forbes & Associates Pty Ltd
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RFA News
Some changes to bring you this news as it happens:

You are invited to "follow" RFA on Twitter, our name is This Twitter account will only be used to bring you headlines for relevant regulatory affairs news for OTC and complementary medicines, foods and cosmetics, as it comes to hand.

More detailed news will be posted on the front page of the site and regularly updated.

On-line store
This will allow you to purchase document templates (such as finished product specifications for various dosage forms) and one-hour Skype courses

Along with the popular half-day and full day training courses held on site at RFA office, we are now offering one-hour courses via Skype. Skype is a free download. This enables you to attend a personalised live training session. Around 20 one hour courses are available to be purchased via the store.

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TGA News

Redeveloped TGA website
The TGA has redeveloped the corporate website (launch date 4 May) and issued some information sheets to help users locate their regularly used pages.
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Input on proposed revision of PIC/S Guide to GMP Annexes 6 & 13
PIC/S has proposed revisions of Annexes 6 and 13 for adoption, relating to the manufacture of medicinal gases and of investigational medicinal products respectively. The TGA is seeking industry comments to these proposed revisions before 4 May 2011.
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Extension of consultation RASML Update 6
The TGA has extended the period of consultation for the proposed changes to Required Advisory Statements for Medicine Labels (RASML) Update 6.
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Changes to annual charges and LVT 2011-12
From 2011-12, the TGA will no longer offer the option of paying annual registration or listing charges or annual charges for inclusion in the Register by installments. Instead, it will be necessary for sponsors to pay these annual charges for 2011-12 in full by 1 October 2011. Requests by sponsors for the cancellation of their therapeutic goods must be received by the TGA before 1 July 2011 in order to avoid an annual charge for the 2011-12 financial year.
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Australian regulatory guidelines for complementary medicines (ARGCM)
In March 2011, the ARGCM was updated to correct administrative issues such as typographical errors and broken website links.
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Better public access to information on the ARTG
Consumers, health professionals and industry now have better access to information about medicines and medical devices approved for use in Australia by the TGA. Information about these goods can be found on the ARTG, an electronic version of which can be accessed on the TGA's website. A change has been made to streamline selection and searching of the ARTG.
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Compliance with ministerial and default standards
All medicines and therapeutic goods in general, must comply with certain standards before they can appear in the ARTG. In most cases these are 'default standards', which are publicly available authoritative standards provided by the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia – National Formulary. In some cases a minister may, by legislative instrument, specify an alternative 'ministerial standard', whether or not a default one exists.
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Guidance on equivalence of herbal extracts in complementary medicines
The Office of Complementary Medicines has developed a new guidance document to assist sponsors of medicines that contain herbal substances.
The document entitled "Guidance on equivalence of herbal extracts in complementary medicines" V1 (February 2011) assists sponsors of medicines containing herbal extracts to determine how and when a herbal extract may be considered 'equivalent' to an ingredient currently included in a therapeutic good and also when it may be used as a substitute without causing the product to be considered a 'separate and distinct good'.
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Guidance on modified unprocessed herbal materials in complementary medicines
The Office of Complementary Medicines has developed a new guidance document to assist sponsors of medicines containing herbal substances. The document entitled "Guidance on the use of modified unprocessed herbal materials in complementary medicines" V1 (February 2011) assists sponsors in identifying situations where the composition of an unprocessed herbal material has been modified to the extent that it is significantly different from the original material approved for use in listed or registered medicines.
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Advisory committee on complementary medicines (ACCM)
The ACCM was formed in January 2010 to advise and make recommendations to the TGA on the inclusion, variation or retention of a complementary medicine in the Australian Register of Therapeutic Goods. ACCM supersedes the Complementary Medicines Evaluation Committee (CMEC) and has an increased focus on the advisory role within the regulatory framework of complementary medicines.

A major role for ACCM is to provide scientific and policy advice relating to controls on the supply and use of complementary medicines in Australia. The ACCM provides this advice with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.
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Health alerts
The TGA is aware that some Australian consumers have purchased certain herbal capsules (Saturo, Satibo, Fu Yuan Chun and Superpowerful Man) over the internet. Analysis undertaken by the TGA Laboratories has found the presence of therapeutic quantities of active ingredients used in prescription-only medicines, indicated for the treatment of male erectile dysfunction. In Australia commercial supply of these products is illegal. The TGA has advised consumers to cease using these herbal capsules and discard any remaining product. Consumers are advised to exercise extreme caution about purchasing medicines from unknown overseas Internet sites.
SATURO capsules ...
SATIBO capsules ...
FU YUAN CHUN capsules ...

TGC 36th meeting summary of key resolutions
The Therapeutic Goods Committee at its 36th meeting held on the 11 August 2010 made a number of recommendations to the TGA including proposed amendments to Schedule 1 of TGO 80, Child Resistant Packaging Requirements for Medicines.
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Review to improve transparency of the TGA
Submissions have been received from individuals and organisations regarding the transparency review of the TGA. These submissions are available on the TGA website for viewing. Note the time for reporting has been extended until 30 June 2011.
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Consultation process outline (new)

Regulation of unregistered health practitioners
A consultation paper has been released by the Australian Health Minister’s Advisory Council which considers if there is a need for strengthened regulatory protection for consumers who use the services of unregistered health practitioners.
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Advisory Committee on Complementary Medicines (ACCM) meeting minutes September 2010
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ACCM meeting minutes December 2010
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Uniform recall procedure for therapeutic goods (URPTG)
Recall co-ordinators contact list updated.
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FSANZ (Food Standards Australia New Zealand) update

Call for submissions on proposed change to food code
FSANZ invited public comment on an assessment report for a genetically modified corn line.
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FSANZ is also seeking comment on applications to irradiate persimmons and to permit low THC hemp as a food.
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Consumers warned not to eat Latin Seed
A slimming product has been recalled in Australia as it has been found to contain a toxic ingredient.
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Fact sheet about quorn (mycoprotein)
Mycoprotein is a source of dietary protein and fibre derived from a fungus. It is used in a limited range of meat-free foods marketed under the brand name Quorn™.
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Fact sheet about pine nuts
FSANZ has investigated consumer reports of a bitter, metallic taste resulting from eating pine nuts. FSANZ has found there are no safety issues that can be identified at this time.
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Food standards news – edition No79
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Food standards news – edition No78
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Chemical gazette March 2011
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Association News
Complementary Healthcare Council of Australia (CHC)

CHC's Annual Industry Leaders' Parliamentary Reception – "For Australia's Health"
Date: 25 May 2011
Location: Mural Hall, Parliament House, Canberra
A Members Only event, join us to launch the first Industry Audit to key political leaders outlining the breadth of the Complementary Medicines Industry across R&D, manufacturing, marketing, exports, education and retailing. Join us for the evening to discuss the industry and to share insights and perspectives and fine food and beverages with those that count.

Complementary Medicines Regulatory Reform – Know your Obligations'
Date: 21 June 2011
Location: Brisbane
With so much happening and things changing so fast this year within the Complementary Medicines regulatory arena, it is vital to stay abreast of these risk issues crucial to your company.
•  TGA Processes; Restricting and Streamlining
Industry Reviews; Regulatory Processes
TGA Transparency Review
TGA ANAO audit
A 'must attend' event for raw material suppliers, manufacturers, exporters, importers, suppliers, sponsors, wholesalers, distributors or retailers.

To find out more or to secure your ticket for the leaders dinner or to register your interest for the Regulatory Reform seminar, please contact Sophie Dimmock:
Tel: 02 6260 4022
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
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Conferences & Meetings
Supply Side East
May 2-4, 2011 Meadowlands Exposition Centre, Secaucus, New Jersey
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Vitafoods International
May 10 – 12, 2011 Geneva Palexpo, Switzerland
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Sports & Performance Nutrition 2011 2nd International Conference
May 26 -27, 2011, Amsterdam The Netherlands
Read more ...

Natural Products Asia
August 25 – 27, 2011 Hong Kong Convention & Exhibition Centre
Read more ...

Natural Products Expo East
September 21-24, 2011 Baltimore Convention Centre, Baltimore Massachusetts
Read more ...

ASMI AGM, Annual Conference & Awards Dinner
November 16, 2011, Sydney venue TBA
Read more ...

TGACC Advertising seminars
2011 seminar schedule
Read more ...
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RFA services
We are very flexible … whatever your regulatory needs we can help

With 30 years of regulatory experience and a network of industry contacts, RFA can provide expert regulatory advice – whether it’s checking your in house regulatory work, training your regulatory staff, up-skilling new employees, checking a label, setting up stability protocols, handling entire product listings or responding to a section 31 so you can keep your product on the market. Whatever the regulatory job we can work with you, no matter how small or large the job is.

RFA can help you put extra regulatory checks in place to safeguard your business. And there are no regular monthly commitments or long term contracts, you brief us on what you want done and we complete each task accurately and promptly.

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