Aug., 2002 - The Essential Technical & Regulatory E-News - Local & International

The Essential Technical & Regulatory E-News– Local & International

Provided by Robert Forbes & Associates Pty Ltd, Sydney, Australia

TGA News

Caffeine Labeling

CMEC has recommended that labels on products containing those herbs known to contain caffeine, declare that the goods contain, or may contain caffeine - unless the sponsor can demonstrate the product does not contain caffeine. Homoeopathic medicines more dilute than 1X are exempt from this requirement.


Proposed Scheduling of Neem

The National Drugs and Poisons Scheduling Committee (NDPSC) has agreed to defer any further consideration of the scheduling of Azadirachta indica (Neem) to its next meeting on 15-17 October 2002. The Committee noted that a number of interested stakeholders had not made a public submission on the scheduling of Neem to the February 2002 meeting, as the Gazette notice only referred to a proposal to schedule azadirachtin, one of the pesticidal active components of Neem. Accordingly, the Committee agreed to recommence the public consultation process at the October 2002 NDPSC meeting. Submissions by COB 4 September 2002. Email - [email protected]


Adoption of PIC/S GMP Guide as a Manufacturing Principle

On 16 April 2002, the Therapeutic Goods Committee (TGC) recommended that the current Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products (August 1990 edition) be replaced with the current Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP Guide for Medicinal Products (15 January 2002 edition).

The PIC/S GMP Guide is virtually identical to the European Community (EC) GMP Guide. The main difference being the use of the term "authorised person" in the PIC/S Guide and "Qualified Person" in the EC GMP Guide. Copies of the current PIC/S GMP Guide for Medicinal Products can be obtained from the PIC/S web site at Seminars see Conferences and Meetings


GMP For Starting Materials

Therapeutic Goods Manufacturing Principles Determination 1 available at -

TSE Draft Document

The revised draft document on Supplementary Requirements for Therapeutic Goods for minimizing the risk of transmitting spongiform encephalopathy (TSE) has been released for comment (by 30th August 2002). Revisions include contact lens care products, medicines intended for parenteral, ophthalmic and intra-tracheal administration and implantable medical devices are now required to be submitted to TGA for evaluation rather than self-assessment.

Exporting Medicines from Australia

TGA has made available Guidelines for exporting medicines from Australia These guidelines should be read in conjunction with the document "Policy for the Export of Medicines from Australia" which outlines the objectives of the Australian regulatory system for export medicines and the relevant legislative framework.

Australian Guidelines for the Registration of Drugs 2 – Supplement 1 Amendments

Guidelines for specific product categories and substances have been amended to include guidelines for ‘family pack’ and ‘metered dose aerosols – spacer devices’ and there is an amended guideline on sodium content for oral products.

TGA FEES clarification

An error was made in the new fee schedule for Export certificate and Certificate of GMP Compliance. The fee actually rose from $70 to $75 (not to $150 as was incorrectly entered). The current version of fees is correct


The TGA has initiated a voluntary recall of all complementary medicines containing the herb kava. The TGA has taken the action following the death of a woman recently in Australia who used a medicine containing kava. Sponsors and retailers have been asked to remove all products containing kava from the market place immediately. The TGA has 87 products containing kava on its register that are able to be sold, although not all of these products would necessarily be available on the market.

List of products containing Kava -

Conferences and Meetings 2002

NHAA Women in Health Seminar

Seminar includes information on HRT, endometriosis, herbal medicines for menopause, and the oral contraceptive pill – safety and herbal interactions.

October 19 – Sydney

Contact mailto:[email protected] or phone (02) 95607077


New Code of GMP – seminars

August 28,Australian Technology Park, Sydney, 1.00pm – 6.00pm, followed by a Cocktail Function. (organized by ASMI, RACI & APMA) Lin Webb ([email protected])

September 2, Brisbane, Robyn Wood ([email protected])

September 5, Melbourne, Tony Rowland ([email protected])

Late October, Perth, Diana Barron ([email protected])

ASMI Conference

September 12, Le Montage, Frazier St, Leichhardt, Sydney

“On the Level: A New Balance for Consumer Healthcare Products”

National Herbal Medicine Week

September 16 – 22 Contact mailto:[email protected] for further details

First Asia Conference on Dietary Supplements (IADSA)

September 24-25, Bangkok,Thailand

Natural Healthcare Conference 2002

September 28 – 30, Sydney Convention& Exhibition Centre, Darling Harbour, Sydney

Contact – Event Managers phone –(02) 9299 9673

Natural Healthcare Expo 2002 (previously named CHC Expo)

September 29 – 30, Sydney Convention& Exhibition Centre, Darling Harbour, Sydney

Phone – (02) 9290 1234 or (03)95302500

Adoption of PIC/S GMP Guidelines Workshop

1 – 2 October, Holiday Inn, Potts Point, Sydney

Register online at or phone the CHC on 02 6260 4122 for further details

Importing/Exporting Restricted Substances (TGA Information Seminar)

2 October 2002, Edmund Barton Building, Barton ACT

Ms Sharyn McGregor, Phone 02 6270 4384, Email [email protected]

Pharmacy Australia Congress 2002, Hobart

October 18 – 20, Wrest Point,Hobart, Tas Contact (03) 9903 9585 or

Pharmacovigilance - the Study of Adverse Drug Reactions

4 – 15 November, Canberra

The Natural Health Fair 2002

November 13-15, Hong Kong Convention&Exhibition Centre

Asia’s International trade event.

Pharmaceutical Science Beyond the Genome: Harnessing the Potential

8 – 11 December, Carlton Crest Hotel, Melbourne

Business Opportunities


Agent for Personal Care Products Wanted

A European manufacturer of personal care products based in Greece is looking for an agent to promote the supply of its products in Australia. Visit and direct your email questions to George Xynolgalas at [email protected]

USA Organic Winery Looking for Australian Distributor

An organic winery in the USA would like to find a distributor in Australia. contact Phaedra LaRocca at [email protected]

Additional Medicines and Medical Devices to Add to Portfolio in India

A large Indian distributor of medicines and medical devices to hospitals is looking for additional product ranges to add to its catalogue. Interested persons please contact M K Modi at [email protected]

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