July August 2010 Newsletter

Issue 101 - July-August 2010	Published by Robert Forbes & Associates Pty Ltd http://www.robert-forbes.com/
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Topics

RFA News
Medicines
- TGA News
Foods
- FSANZ Update
Cosmetics
- NICNAS News
Association News
Conferences and Meetings
RFA Training Courses

Current Affairs 100th issue celebrations
Thank you to all those who participated in our 100th issue of Current Affairs competition. Our two lucky winners are enjoying their red balloon vouchers!!

RFA announces new training on GMP responsibilities RFA is offering a ½ day (4 hours) training session at our Glebe office on the new manufacturing principles that became mandatory 1st July for Australian medicines after the adoption of the PIC/S Guide to GMP for Medicinal Products 2009. The agenda will cover:
•	product quality reviews
•	ongoing stability programs
•	how to review your contractual arrangements
•	reference and retention samples
•	complaints and product recalls
Training sessions are conducted for up to four people, from one company only at a time. For further information please contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it

TGA News

Applying for low value turnover exemption from annual charges
The TGA has changed the due date for applications for Low Value Threshold (LVT) exemptions from 1 November to 2 September 2010.
Read more ...

Access to IV thiamine
The TGA is notifying clinicians that it is no longer possible to extend the previous exemption for Baxter Healthcare to supply IV Thiamine in Australia. The TGA is working closely with Baxter to identify an alternative supply mechanism. At the present time, the only available options for supply of this product are under the Special Access Scheme of the Therapeutic Goods Act or the Authorised Prescriber scheme of the Act. An alternative registered product has been suggested.
Read more ...

Safety advice ? 1 Body Beautiful
In May 2010, the Hong Kong Department of Health issued an alert concerning a product known as 1 Body Beautiful which had been found to contain the undeclared pharmaceutical substances sibutramine and phenolphthalein.
Read more ...

Audit of medicine manufacturers
The Office of Manufacturing Quality (OMQ), of the TGA is responsible for licensing of Australian manufacturers and audits of Australian and overseas manufacturers wishing to supply therapeutic goods in Australia. Information on scheduling, frequency and duration of audits can be found on the TGA website as well as standards for overseas manufacturers.
Read more ...

Implementation of new manufacturing principles for medicinal products A comparative summary of the changes in the new manufacturing principles is available on the TGA website, the main changes include:
•	The introduction of quality risk management (QRM) requirements (and voluntary Annex 20).
•	The introduction of product quality reviews (PQR).
•	Expanded procedures for on-going stability testing programs.
•	Expanded procedures for reference and retention samples.
•	Revisions to sterility requirements set out in Annex 1.
•	The inclusion of the ICH GMP Guide for Active Pharmaceutical Ingredients (APIs) as Part II of the Code and the application of relevant Annexes for API manufacturers.
•	The revocation of the unique Australian Code of GMP for sunscreens.
The TGA's expectation is that by 1 July 2010, manufacturers would have completed their assessment of the impact of the new manufacturing principles on their operations, and that they will have completed, or be well advanced, towards updating quality systems documentation and implementing revised practices. However, the TGA does not expect that all manufacturers will have data immediately available to meet some of the new requirements which became mandatory on 1 July 2010. As a result, a phased approach will be taken to assessing compliance. Read more ...

Advisory committee on complementary medicines (ACCM)
The Advisory Committee on Complementary Medicines (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). Remaining ACCM meetings 2010 are Sept 3rd and Dec 3rd.
Read more ...
ACCM extracted ratified minutes, Meeting 1, 5 March ...

Therapeutic goods (articles that are not medical devices) order No 1 of 2010 Effective July 1, 2010 the following articles are declared not to be medical devices:
•	chemical oxygen generators
•	in-vivo imaging agents injected, ingested, or otherwise instilled into the body
•	an article that is intended to administer a medicine in such a way that the medicine and the article form a single integral product which is intended exclusively for use in the given combination and which is not reusable (may be multi-dose)
•	articles incorporating tissues, cells or substances of human origin, other than medical devices incorporating stable derivatives of either human blood or human plasma that act on, or are likely to act on, the human body in a way that is ancillary to the device
•	articles incorporating viable tissues, cells or substances of animal origin; and
•	hospital grade or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides.
Read more ...

Australian regulatory guidelines for OTC medicines
The project to review and amend the current Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM), published in 2003, 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 began October 2008 and is due for completion in December 2010. It is intended that the updated ARGOM will be published in 2011.
Read more ...

Template for a new compositional guideline
Read more ...

Updated advice to consumers on hydroxy cut products
Read more ...

TGA news issue 59 (July 2010)
Read more ...

National drugs and poisons schedule committee
Record of reasons for 59th meeting June 2010
Post meeting gazette for 59th meeting June 2010

European union guidelines ? newly published
Read more ...

Adoption/non-adoption of European Union guidelines in Australia
Read more ...

FSANZ (Food Standards Australia New Zealand) update

Government announces BPA baby bottle phase out
The voluntary phase out of baby bottles containing bisphenol A (BPA) by the Wesfarmers group (Coles, K Mart and Target), and retailers Woolworths, Big W and Aldi is the result of months of constructive discussions between the Australian Government and retailers. The phase out will began on July 1.
Read more ...

FSANZ invites public comment on food from GM cotton
FSANZ invited individuals and organisations to provide comment on an application to approve a genetically modified food. The application is for a cotton variety that has been genetically modified to confer insect protection and herbicide tolerance. To date, FSANZ has approved more than 40 such applications for food derived from GM crops.
Read more ...

Food standard news winter edition 2010
Read more ...

NICNAS News

Chemical gazette July 2010
Read more ...

Complementary Healthcare Council of Australia (CHC)

2010 National Conference & Awards Night
The CHCs 2010 National Conference titled 'Delivering Preventative Healthcare Today and Helping to Build a Sustainable Future' is coming up soon!

This year we welcome a huge lineup of speakers including our international keynote guests - Mark Blumenthal (American Botanical Council), Dr Bruce Holub (DHA/EPA Omega-3 Institute) and Jeff Hilton (Integrated Marketing Group), as well as Professor Kerryn Phelps, Dr Rohan Hammett (TGA), Michael Smith (TGA), Dr Susan Murch, Professor Alan Bensoussan, Karen Longstaff (TGA) and Professor Ian Brighthope.

More information on our speakers and their presentations can be found on the Conference website.

Date: 28-29 October 2010
Venue: Crowne Plaza Surfers Paradise
RSVP: Registrations will close 15 October 2010

Book, register and submit online now!
You can now book accommodation, register for the Conference and Annual Industry Awards dinner and submit your abstract all on the same website!
To access our Conference website please click here

www.chc.org.au

Third Australian Food Safety Conference
September 7 ? 9, Crown Conference Centre at Crown Promenade, Melbourne
Read more ...

Natural Health Conference and Expo
September 16 -17, Aotea Centre, Auckland, New Zealand
Read more ...

The Organic Summit
October 13, Seaport Hotel, Boston, Massachusetts, USA
Read more ...

Natural Products Expo East
October 13 ? 16, Boston Convention & Exhibition Centre, Boston, Massachusetts, USA
Read more ...

Supply Side West
October 19-23, The Venetian & Sands Expo, Las Vegas, Nevada, USA
Read more ...

CHC 2010 National Conference & Annual Industry Awards
October 28 ? 29, Crowne Plaza, Surfers Paradise, Queensland
Read more ...

ASMI Conference & AGM ? Bringing Self Care to Life
November 18, Australian Technology Park, Redfern, Sydney
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 ...

New half-day course now available:
•	Overview of GMP responsibilities ? including product quality reviews, stability, GMP contract agreements

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
•	Overview of advertising regulations for foods, cosmetics and medicines, for marketing executives

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

Last Updated on Friday, 03 September 2010 09:08

robert-forbes.com.au - Robert Forbes and Associates - Regulatory and technical advice to suppliers and manufacturers of complementary medicines, dietary supplements, OTC medicines, cosmetics, personal care products and foods.

July August 2010 Newsletter

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