Issue 76 - January 2008
The Essential Technical & Regulatory E-News - Australian & International

Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

www.robert-forbes.com


• Medicines
• TGA news
• Foods
• FSANZ update
• Association News
• International news
• Conferences and meetings
• Industry Classifieds

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Revised requirements for the labelling of medicines
Stakeholders are being asked to comment on a proposed revision of requirements for the labelling of medicines. The closing date for comment is Friday 29 February. It is proposed that Therapeutic Goods Order No 79 General Requirements for the Labelling of Medicines (TGO 79) will supersede TGO 69 as a standard made under section 10 of the Therapeutic Goods Act 1989. TGO 79 (draft) incorporates a two year transition period for products to comply with the revised requirements.
A guidance document contains a summary of the main differences between TGO 79 and TGO 69 some of these differences include:
• New definitions included (such as calendar pack, health professional, starter pack etc)
• Label presentation - some changes to font size requirements
• Prescription medicines require excipient declarations on label/pack insert
• Shift of active ingredient names in herbals, vitamins and/or mineral products to side or rear panel extended to all listed medicines with two or more active ingredients
• New concessions for very small containers
• Homoeopathic medicines - statement required on main label that it is or contains homoeopathic medicines
• New concession for strip, blister and dial dispenser packs
• Vitamin A content to be expressed as retinol equivalents
• Permitted statements of storage conditions expanded
• New requirement for statement regarding severe allergic reaction on bee pollen, propolis and royal jelly products Read more …

Revised requirements for child-resistant packaging
Comments from stakeholders are being sought on a proposed update to requirements for the child-resistant packaging (CRP) of medicines. The closing date for comment is Friday 22 February 2008. Read more …

Complementary Medicines Evaluation Committee 64th meeting
The public recommendation summary of the December meeting contains a summary of recommendations to TGA:
• Arabinogalactan derived from Larix occidentalis or Larix larcinia, with a high-grade purity (polysaccharide content > 85%), is suitable as an ingredient in Listed therapeutic products, subject to a maximum daily dose limit of 15 g, and resolution of outstanding composition issues.
• A maximum daily dose limit of 10 mg be adopted for piperine when present as a component in herbal preparations for use in Listed medicines.
Convolvulus arvensis, Periploca sepium and preparations of the raw tuber Pinellia ternata are not suitable for use as ingredients in Listed medicines. Read more …

Substances that may be used in listed medicines in Australia - updated
An updated list of substances eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia is now available. This list was updated on 12 December 2007 and is subject to change from time to time as new substances are approved for use in Listed medicines. Read more …

National Drugs and Poisons Schedule Committee - pre-Feb notice
The next scheduling meeting of the NDPSC will be held on 19-21 February 2008. Substances to be considered for scheduling by the NDPSC are open for public comment. Items to be considered include: consideration of schedule 4 entry for Kava (piper methysticum); consideration of scheduling of fluorides for human use; consideration of scheduling of boron. Read more …

Adoption of British Pharmacopoeia 2008 (BP 2008)
Stakeholder consultation has been sought on the TGA proposal to adopt BP2008 (published in August 2007) as the edition of that standard defined under the Act. Read more …

A guide to labelling drugs and poisons
The Guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the SUSDP requirements as they exist on 1 January 2007. The information it contains is not complete nor is it intended to be the sole source of reference. To assist the reader to refer back to the SUSDP, references to relevant paragraphs and sub-paragraphs have been included in this guide. Read more …

Therapeutic Goods Committee 31st meeting
The TGC 31st meeting was held on 29 November recommendations were made to the TGA in the following areas:
• Adoption of British Pharmacopoeia 2008
• Revision of Therapeutic Goods Order No 65 Child-resistant packaging for therapeutic goods (TGO 65)
• Development of a best practice guideline for non-reclosable forms of child-resistant packaging
• Update to edition of required advisory statements for medicine labels (RASML) referenced in Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)
• Labelling requirements for medicines - revision of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)
• Standards for tablets and capsules - Revision of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56)
• Microbiological standards for medicines
• Proposal to establish a subcommittee to advise on standards for biologicals
• Review of the Code of Practice for the Tamper-Evident Packaging (TEP) of therapeutic goods
• Transfer of packaging requirements from Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
• Proposal to establish a subcommittee to advise on packaging matters relating to therapeutic goods Read more …

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FSANZ seeks public comment on possible changes to food standards code
FSANZ has invited comment on changes to amend the Australia New Zealand Food Standards Code.
• Addition of galacto-oligosaccharides, long chain inulin to infant formula products and infant food
• Addition of lutein to formulated supplementary foods for young children
• Addition of inulin/fructo-oligosaccharides (FOS) and galacto-oligosaccharides in infant formula products, infant foods and formulated supplementary foods for young children, and to provide that added inulin/FOS is taken to be not a nutritive substance when added to general foods.

Among other items being considered are possible labelling of alcoholic beverages with a pregnancy health statement, revised residue limits in food, the addition of calcium to some chewing gum, food from genetically modified cotton and corn, and food safety programs for catering to the general public. In addition, FSANZ is releasing a consultation paper on nutrition and health claims to obtain community feedback on three issues before the FSANZ Board makes a final decision on the rules governing the use of these claims by food manufacturers. Read more ...

Pregnancy health advisory labels on alcoholic beverages
The Alcohol Advisory Council of New Zealand has asked FSANZ to amend the Australia New Zealand Food Standards Code to require a health advisory label on alcoholic beverage containers advising of the risks of consuming alcohol when planning to become pregnant and during pregnancy. Read here …

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Complementary Healthcare Council takes issue with Dr Ken Harvey and the AMA on the regulation of complementary medicines.
The Complementary Healthcare Council is concerned by calls for a change to the regulation of complementary medicines and has strongly defended the current regulation of complementary medicines following the release of a paper authored by Dr Ken Harvey and others in the Medical Journal of Australia. Executive Director, Dr Tony Lewis said that contrary to what Dr Harvey claims, controls on the supply and promotion of complementary medicines are strong.

It is a concern to the Complementary Healthcare Council, as it should also be for medical practitioners and consumers, that AMA president Rosanna Capolingua and other AMA spokespersons are calling for regulatory changes based on the un-substantiated personal opinion of the paper's authors. The CHC argues Dr Harvey's proposal to scrap the listing system and assess all complementary medicines for efficacy flies in the face of sound, efficient and economic risk-based regulatory practice.

The CHC, however, does support one of the papers recommendations that more should be done to increase medical practitioner and consumer understanding of Australia's strong and reputable regulatory system for medicines and particularly complementary medicines.

The Complementary Healthcare Council will meet with the new Parliamentary Secretary for Health, Senator Jan McLucas to re-state the case for a common sense approach to complementary healthcare products based on appropriate risk management.

Complementary Healthcare Council seminar: New Zealand Regulatory Changes -impacting dietary supplements!; Importing/Exporting Dietary Supplements?; New Zealand regulatory changes will affect you!

Thursday, 28 February 2008, 10.00am 2.00pm -The Menzies Hotel, Sydney

Changes to the Dietary Supplements Regulations 1985 and enforcement are currently taking place in New Zealand.

This seminar is a must to attend if you are:
• involved in the manufacture, distribution and advertising of dietary supplements in New Zealand;
• import into Australia, distribute, advertise and retail dietary supplements from New Zealand;
• an industry consultant.
Speakers include: Medsafe, New Zealand Food Standards Safety Authority, Therapeutic Goods Administration, Food Standards Australia New Zealand and Clayton Utz.
Contact the Complementary Healthcare Council offices on 02 6260 4022 to register or email Kristy Roberts - This email address is being protected from spambots. You need JavaScript enabled to view it.

www.chc.org.au


New Zealand regulation seminars for industry
Medsafe and the NZFSA have jointly advised that the administration of therapeutic products under the Dietary Supplements Regulations 1985 (DSR) will transfer this year from NZFSA to Medsafe, bringing enforcement of existing legislation and new requirements for companies involved in the manufacture, sale, distribution and importation of therapeutic products in New Zealand The current existing legislation of the DSR is aimed at filling the regulatory gap until a more suitable regulatory model can be put in place. In the meantime NPNZ believes that companies need more information on the changes to the DSR and to understand what the DSR really means for individual companies. Accordingly NPNZ has invited Medsafe and NZFSA to speak to the industry so that companies can receive a better understanding of the changes and enforcement of the DSR.

NPNZ is hosting two seminars in February and NPNZ will continue to dialogue with Medsafe and the government over the amendments and administrative application of the DSR 1985 to ensure companies are informed and consulted as much as possible.

AUCKLAND: Thursday 21 February 2008, 2pm
CHRISTCHURCH: Friday 22 February 2008, 10am

To attend RSVP to Amanda by phone 09 379 2121 or email This email address is being protected from spambots. You need JavaScript enabled to view it. by Thursday 19 February.

New Zealand based naturalhealthreview.org is a new independent source of the best scientific evidence available in natural health.
The organisation produces a monthly free update for consumers and health professionals showing ten of the most significant worldwide studies in the area with a simple explanation and recommendation from leading expert Dr Shaun Holt.

The Review is currently distributed throughout the Asia-Pacific Region through professional societies and via an ever growing database of subscribers. This journal is the perfect vehicle for evidence based companies who want to advertise their well-researched products to an influential audience including doctors, pharmacists, natural health professionals and consumers.

As well as the regular journal, all previous studies are stored on the website. These are categorised under conditions and therapies and provide a library of easily digestible information on the best research and the best natural therapies available. There are additional advertising options for the website in addition to the journal.

Subscribe free at www.naturalhealthreview.org or send any enquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.

2008 New Zealand Natural Products Industry Summit - Rotorua 10 April 2008
www.naturalproductsnz.org

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EC change on health claims
A decision has been made by the European Commission to allow health claims based on new scientific data. The new procedure will enable companies to have their file approved through an accelerated procedure, and allows exclusive use of their proprietary data for five years.
Read more …

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Natural Products Expo West
March 13 – 16, 2008, Anaheim Convention Centre, Anaheim USA
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The 3rd International Congress of CM Research 2008
March 29 – 31, 2008, Sydney Convention Centre, Darling Harbour Sydney
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Natural Products Expo Asia
June 26 – 28, 2008, Hong Kong Convention and Exhibition Centre, Hong Kong
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Nutracon Europe
June 14 – 15, One Whitehall Place, London UK
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Healthy Foods International
June 18 – 19, Dallas Convention Centre, Dallas, Texas USA
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Organic Products Expo – BioFach America
September 26 – 29, 2008, Baltimore Convention Centre, Baltimore USA
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Natural Products Expo East
October 15 – 18, 2008, Boston Convention & Exhibition Centre, Boston USA
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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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