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HomeNews CentreArchive newslettersMay June 2010 Newsletter

May June 2010 Newsletter

Current Affairs
Issue 100 - May-June 2010 Published by Robert Forbes & Associates Pty Ltd
http://www.robert-forbes.com/
This newsletter is sent to clients of RFA at no charge.
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Topics

RFA
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RFA News
Regulatory Affairs Help Desk
with toll free number
for RFA clients in USA and Canada


Get quick answers to your questions about Australian and New Zealand regulations for Foods ? Dietary Supplements ? Complementary medicines ? Cosmetics
available from 9am Sydney time, Monday - Friday

Easy access to expert advice, charged at our normal rate.
Click This e-mail address is being protected from spambots. You need JavaScript enabled to view it to have your account manager contact you with your toll-free number.

Want to use our Help Desk but not currently a client of RFA?
Contact Robert Forbes by This e-mail address is being protected from spambots. You need JavaScript enabled to view it or on +612 96608027 to discuss how we can help you.

Supplying sunscreens in Australia
Australia has the highest incidence of melanoma world-wide, and as a result, primary sunscreens are regulated as medicines, not as cosmetics. They must be manufactured in a facility that meets GMP requirements and must also comply with the Australian and New Zealand Standard for sunscreens, AS/NZS 2604 Sunscreen products, evaluation and classification. Your primary sunscreens must be listed on the Australian Register of Therapeutic Goods, or secondary sunscreens with NICNAS, before they can be supplied in Australia.

The two common problems with sunscreens manufactured outside Australia are:
Manufacturer is not audited for compliance with pharmaceutical GMP; and/or
Sunscreen has not been tested to the mandatory standard or does not comply.

We work with Australia?s pre-eminent sunscreen development and testing laboratory to ensure your product meets the relevant mandatory standards, or re-formulate when necessary to bring the product into compliance. This facility can also conduct full stability study, including analytical validation. We can also advise your manufacturer on GMP compliance that is acceptable to the TGA, or refer you to another acceptable manufacturer. When the product has met all requirements, we submit the formulation and manufacturing details to the TGA, and within a few days you will obtain from the TGA the unique number that must appear on your packaging and labelling. Contact Robert Forbes for assistance.


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Medicines
TGA News

Fourth bill passed by parliament
On Thursday 13 May 2010, the Therapeutic Goods Amendment (2009 Measures No 3) Bill 2009 and the associated Therapeutic Goods (Charges) Amendment Bill 2009, were passed by Parliament. The Bill makes a number of amendments, principally to:
Implement a new framework for the regulation of biologicals (human cellular and tissue based therapy products)
Provide more flexible arrangements to recall batches of goods
Enable information to be sought from past sponsors of medicines and therapeutic devices but only for the 5 year period before the request is made
Improve the operation of the Act through a range of minor technical amendments
Read more ...

Revised medicines and chemicals scheduling arrangements
Revised scheduling arrangements for medicines and chemicals take effect on 1 July 2010. The changes include:
the National Drugs and Poisons Schedule Committee (NDPSC) will be replaced by the Secretary of the Department of Health and Ageing (DoHA)
two new expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, will be established
a single Secretariat, supporting both Advisory Committees, will ensure ongoing consistency and cohesiveness of processes and decisions; and
closer integration of the revised scheduling arrangements with existing Commonwealth evaluation and product registration schemes.
Other planned changes include:
the Poisons Standard, at present named the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), and
cost recovery arrangements are being examined.
Read more ...

Advisory committee on non-prescription medicines (ACNM)
The ACNM is a new statutory committee established under the Therapeutic Goods Regulations 1990, effectively replacing the Medicines Evaluation Committee. The TGA is seeking expressions of interest from experts interested in contributing to the work of the TGA through the ACNM. The term of appointment will start on 1 January 2011 and will be until 31 December 2013.
Read more ...

Advertising and supply of therapeutic goods to complementary healthcare professionals
A new fact sheet addresses misunderstandings about the aims of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 and their effect on the ability of complementary healthcare professionals obtaining access to therapeutic goods and related advertising material.
Read more ...

Office of manufacturing quality complaint process
A new document outlines the principles and process for complaints. The OMQ aims to resolve complaints informally wherever possible, but more serious concerns can be made in writing and there is a process for dealing with these.
Read more ...

Australian regulatory guidelines for OTC medicines - sunscreens
The TGA is seeking comments from interested parties on proposed revisions to guidelines on sunscreens in the Australian Regulatory Guidelines for OTC (over the counter) Medicines (ARGOM). These revisions will provide a complete, clear and single source of information on Australian requirements for sunscreen regulated as therapeutic goods, and will replace the current chapter 10 'Sunscreens' in the ARGOM.
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 Therapeutic Goods Administration (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). 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.
Read more ...

Medicines safety update No 3, 2010
Published in the June 2010 issue of Australian Prescriber, this issue contains:
AUST R and AUST L numbers ? why are they important?
Sibutramine
Drug-induced pancreatitis and exenatide (Byetta)
What to report
Read more ...

Isomalt and sugar alcohol warnings on labels
As outlined in Schedule 1 of the Therapeutic Goods Order 69 ? General Requirements for Labels for Medicines (TGO 69), where the total sugar alcohol content of a product exceeds 2g per maximum daily dose, the product label is required to declare the total amount of sugar alcohols as well as include a warning statement.
Read more ...

Draft compositional guideline for Euphausia superba (Antartic krill) oil
Available for comment until the 11th June.
Read more ...

Draft compositional guideline for Caralluma adscendens var. fimbriata
Read more ...

Copies of presentations by the TGA office of manufacturing quality
Copies of the following presentations are available to download:
New manufacturing principles and GCP initiatives
Shelf life stability studies
Draft product quality review for Listed complementary medicines
Update to the manufacturing principles for medicinal products
Read more ...

Copies of presentations - regulating advertising of therapeutic goods in Australia
Copies of the following presentations are available to download:
Regulating the advertising of therapeutic goods in Australia
The therapeutic good advertising code explained
Read more ...

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Foods
FSANZ (Food Standards Australia New Zealand) update

Australia and New Zealand food regulation ministerial council
Ministers responsible for food regulation in Australia and New Zealand finalised a draft intergovernmental agreement that will assist Australian consumers and industry to understand food regulation in Australia.
The ministerial council has almost completed the development of a bi-national compliance strategy for caffeinated energy drinks.
The ministerial council considered a report by Food Standards Australia New Zealand (FSANZ) on Bisphenol A (BPA) and requested that the Chair provide a report back to the next Ministerial Council regarding international developments.
Read more ...

Reformulated Bonsoy soy milk without kombu seaweed to return to shelves
Food and Health authorities today confirmed that Bonsoy soy milk, reformulated without kombu seaweed extract, could return to sale. On the 24 December 2009, FSANZ coordinated a national food recall and issued a media release advising people not to consume Bonsoy soy milk with all best before dates. This followed a cluster of nine adults aged from 29 to 47, and one child, who presented in NSW with thyroid problems.
An updated fact sheet about Bonsoy soy milk is available.
Read more ...

Food surveillance news autumn edition 2010
Read more ...

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Cosmetics
NICNAS news

Chemical gazette June 2010
Read more ...

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Association News
Complementary Healthcare Council of Australia (CHC)

New application for advertising approval form
The CHC has a newly revised application form for advertising approvals which is to be used by industry for all future advertising applications. The new form can be downloaded at http://www.chc.org.au/Advertising/Approvals/

Members should note the following changes:

Applicants are now required to disclose complaints history related to advertised product(s).
Applicants will tick the type of application being submitted and include relevant previous approval numbers to help expedite invoicing.
Descriptions of the various types of advertising application are now listed on page 2 for applicant?s convenience.
There is a weblink to the TGA?s schedule of advertising fees for quick access.
Applicants will confirm the type of credit card included to assist payments.
To save the planet, the form has been reduced to 2 pages.

www.chc.org.au

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Conferences & Meetings
NBJ Summit
July 20 ? 23, St Regis Resort, Dana Point, California, USA
Read more ...

Nutracon Asia
August 26 ? 27, Hong Kong Convention & Exhibition Centre, Hong Kong
Read more ...

Natural Products Expo Asia
August 26 ? 28, Hong Kong Convention & Exhibition Centre, Hong Kong
Read more ...

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
October 28 ? 29, Crowne Plaza, Surfers Paradise, Queensland
Read more ...

ASMI Conference & AGM
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 ...

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RFA Training Courses
New course now available for marketing staff ? an overview of the TGA regulations including advertising regulations for foods, medicines and cosmetics.
Details at www.robert-forbes.com/training-courses.html

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

Full day course
Food Standards

For more information visit the RFA website

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Terms & conditions
Terms & conditions of entry for the Current Affairs
100th issue competition


1. Entry instructions form part of these conditions.
2. Entry is open to Australian residents receiving the Current Affairs May-June 2010, other than employees and their immediate families of the Promoter, and its related companies and agencies associated with this promotion (each an "Eligible Person"). "Immediate family" means spouse, defacto spouse, parent, natural or adopted child, and sibling (whether natural, or adopted by a parent), whether or not they live in the same household as the employee.
3. Entry commences at 9am on 1/07/10 and closes at 4pm on 15/7/10 (the "Promotional Period")
4. The draw will take place at Level 1, 335-341 Glebe Point Rd, Glebe, NSW 2037 at the RFA offices at 10.00am on the 16/07/10
5. Two prize winners will be drawn by an independent scrutineer by method of random ballot draw from submitted emails.
6. Judges' decisions are final, and no correspondence will be entered into.
7. The prize winners will be notified by 16/07/10 by notification email and their names published in the Current Affairs July-August 2010 newsletter.
8. The prize is a gift voucher that has a printed one hundred dollar value that can be used to purchase from RedballoonDays website. The voucher will be sent by RFA to the prize winners.
9. All RedBalloon gift vouchers, which may be identified by the existence of an expiry date are non-refundable and not exchangeable/redeemable for cash.
10. Redballoon gift vouchers must be used within 12 months of purchase. Expired vouchers are non-refundable in whole or in part. After the voucher has expired, it is no longer valid and all transaction attempts will be declined. Any unused value at the date of expiry will become the property of RedBalloon.
11. To the extent permitted by law, the Promoter, its employees and agents shall not be liable for any claims, losses, damages, injuries, costs and expenses suffered sustained or incurred (including but not limited to indirect or consequential loss, or arising as a result of any negligent act or omission) as a result of, or arising out of, or in any way connected with this promotion and/or its prize.
12. Subject, where relevant, to any directions given under the legislation regulating this promotion, if the prize is unclaimed, it will be awarded in a further draw to be held at 3pm on 26/07/10 at Level 1, 335 - 341 Glebe Point Road, Glebe, NSW, and the name of the winner in this draw, if any, will be published in the Current Affairs July-August 2010 newsletter.
13. Entrant personal information ("PI") will be collected to enable the Promoter to administer and promote this competition. The PI of the winner may be provided to others assisting, including the prize supplier and deliverer, and to authorities that regulate this competition. If an entrant does not truthfully provide all requested PI, the Promoter may determine that they are not eligible to win the prize.
14. The Promoter is Robert Forbes & Associates Pty Ltd, ABN 31 073 915 661, Level 1, 335 - 341 Glebe Point Road, Glebe, NSW 2037.
15. Authorised under NSW LTPS/10/05610

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Last Updated on Tuesday, 17 August 2010 11:53

 

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