Issue 92 - June 2009
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants

http://www.robert-forbes.com/

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Topics


• Medicines
     • New Zealand News
     • TGA news
• Foods
     • FSANZ update
• Cosmetics
     • NICNAS news
• Association news
• Conferences and meetings
• RFA training courses

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New Zealand News


New Zealand Medsafe has written to product sponsors and industry proposing administrative changes which would come into effect on 1 July 2009.
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TGA news


CMEC appointment of new member
The TGA is seeking expressions of interest for a Complementary Medicines Evaluation Committee (CMEC) position, for a person with experience and expertise in the field of consumer representation. Consumer representatives must be capable of reflecting the viewpoints and concerns of consumers; and be persons in whom consumers and consumer organisations have confidence. Expressions of interest must be received by COB 27 June 2009.
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CMEC 71st meeting minutes
CMEC recommends to the TGA that:
•  Oral Listed medicines containing the ingredients Glycyrrhiza glabra and Glycyrrhiza uralensis require a label advisory statement. "Contains liquorice. People with kidney disease or high blood pressure should seek advice from a healthcare practitioner before consuming this product".
•  Preparations of the herb (above ground parts) of Selaginella tamariscina, remain suitable for inclusion in Listed medicines.
•  Only those preparations of the tuber of Pinellia ternata, traditionally prepared as described in the Pharmacopoeia of the Peoples Republic of China, remain suitable for inclusion in Listed medicines.
•  Where consistent with the BP Monograph for KCl, potassium chloride is suitable for use as an ingredient in Listed therapeutic products used for oral rehydration only, subject to appropriate label requirements.
•  The regulation of all potassium salts should be consistent across the range of potassium salts and should be based on potassium content.
•  Solidago virgaurea and Solidago gigantea remain suitable for use as ingredients in Listed medicines.
•  The use of vitamin A in Listed therapeutic products intended for infants and children, be subject to life stage specific upper limit (UL); they will require a label advisory statement as well as require additional regulatory measures regarding release limits for vitamin A in liquid products.
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CMEC 72nd meeting minutes
CMEC recommends to the TGA that:
•  The following were suitable cholesterol claims for medicines: 'May help maintain normal [and/or healthy] cholesterol levels' AND 'May help maintain cholesterol within the normal [and/or healthy] range and improve the HDL/LDL ratio'.
•  A label advisory statement should be used when making indications/claims in relation to blood cholesterol levels: 'Not for the treatment of high cholesterol. Blood cholesterol levels should be regularly checked'.
•  'Calci-Tab 600' (tablets) is suitable for Registration in the ARTG, subject to the appropriate labelling requirements.
•  Any herbal species confirmed as containing aristolochic acids is not suitable for inclusion in Listed medicines.
•  Asarum spp. are no longer suitable for inclusion in Listed medicines, due to the increased potential for preparations of this genera to contain aristolochic acids
•  There is insufficient evidence to warrant a change to the current regulation and labelling of products containing preparations of Cimicifuga racemosa.
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Regulatory reform
On Wednesday 27 May 2009 the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009] was passed by the House of Representatives without amendment. The bill:
•  Provides for medical devices to be exempted in certain circumstances.
•  Clarifies the 'fit and proper person' test and ensures it is applied more effectively and directly to matters relevant to Australian manufacturing;
•  Adopts the European Pharmacopoeia or the United States Pharmacopoeia as additional default standards;
•  Expands the range of therapeutic goods information that can be released to the public and provides a wider range of circumstances where the TGA can release information to Commonwealth agencies or international authorities;
•  Applies more consistency to the regulation of advertisements in all media that include restricted representations to apply requirements to both those that require pre-approval and those that don't.

On Wednesday 24 June 2009 the Therapeutic Goods Amendment (2009 Measures No 2) Bill 2009 was introduced to the House of Representatives. The bill is the third of a series of reforms. The bill will now be debated by the House of Representatives in the spring 2009 sitting of Parliament.
The bill will:
•  Implement new separate scheduling arrangements for medicines and chemicals;
•  Enable the Secretary of the Department of Health and Ageing to declare purposes for which a kind of medical device cannot be included in the ARTG and thus made available;
•  Extend the circumstances in which consultation can occur with the Gene Technology Regulator to therapeutic goods that are or contain genetically modified organisms;
•  Amend the advertising provisions to provide that it is an offence for any person to advertise a therapeutic good inappropriately for a purpose that has not been accepted in relation to the product;
•  Amend the delegation provisions to enable the regulations to specify a relevant person for the purposes of exercising delegation; and
•  Introduce provisions to enable the Minister to specify, advisory statements required to be included on the labels of specified medicines.
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Arrangement between TGA and European Directorate for the quality of medicines and healthcare of the Council of Europe (EDQM)
The TGA has established a cooperative arrangement with the EDQM for the sharing of non-public information between the two authorities associated with the regulation of therapeutic goods. The arrangement will facilitate the participation of both authorities in a pilot project involving European, US and Australian regulators aimed at rationalising international GMP inspection efforts.
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TGC 34th meeting
The summary of key recommendations by the Therapeutic Goods Committee at its 34th meeting includes:
•  Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use: Further work on the document A Guideline on Improving the Performance of Non-Reclosable Packaging for Medicines as a Barrier to Children is being undertaken; and further work will be undertaken to develop an effective order which will transfer container requirements for therapeutic goods from the SUSDP to the control of the TGA.
•  Status report on adoption of multiple pharmacopoeias as default standards.
•  Adoption of British Pharmacopoeia 2009: Effective 1 June 2009.
•  Standards and labelling requirements for homoeopathic and anthroposophic medicines: Proposed changes are planned to commence on 1 July 2011.
•  Medicine labelling - Labelling of transdermal patches: Transdermal patches should have markings which will make each patch uniquely identifiable after application;
•  Medicine labelling - Inclusion of bar codes on medicine labels:
•  Medicine labelling - Units of potency: TGO 69 requires that potency must be expressed in terms of International Units (IU);
•  Medicine labelling - Declaration of excipients: The First Schedule to TGO 69 to be amended with a proposed transition period of two years.
•  Medicine labelling - Prominence of active ingredient names: an increase in font size for active ingredient names.
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Q&A additional default standards legislation
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Cost recovery impact statement
Annual review of fees and charges 2009-10 - Complementary medicines.
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European Union guidelines (updated)
EU guidelines recommended for adoption or non-adoption.
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FSANZ (Food Standards Australia New Zealand) update


Food safety during fires, floods and power cuts fact sheet
Useful advice for consumers and food businesses about food safety during fires, floods and power cuts.
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How much sodium and salt are we eating - fact sheet
Most of the sodium in our food comes from sodium chloride (salt), which is added to foods for flavour and as a preservative. The fact sheet outlines the details.
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Iodised salt from Oct 09
Australian bakers were reminded that they need to replace the salt that they currently use in bread making with iodised salt from 9 October 2009. FSANZ launched the Australian User Guide for Mandatory Iodine Fortification which outlines the details.
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Changes to Food Standards Code
Amendment 108 was gazetted on 28 May 2009. The Applications included:
Application A490 - Exemption of Allergen Declaration for Isinglass
Application A594 - Addition of Lutein as a Nutritive Substance to Infant Formula
Application A597 - Addition of Lutein to Formulated Supplementary Foods for Young Children
Application A1011 - Cellulase from Penicillium funiculosum as a Processing Aid
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Amendment 109 contains amendments to the following Standards:
Standard 1.2.8 – Nutrition Information Requirements
Standard 1.4.1 – Contaminants and Natural Toxicants
Standard 1.6.2 – Processing Requirements (Australia only)
Standard 2.2.3 – Fish and Fish Products
Standard 4.2.4A – Primary Production and Processing Standard for Specific Cheeses (Australia only)
The Proposal under which these amendments are made is Proposal P1008-Code Maintenance VIII.
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NICNAS news


NICNAS news
The June Chemical Gazette is available at the NICNAS website.
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National Herbalists Association (NHAA)


NHAA 2009 seminar series
The changing face of herbal practice with Sue Evans
Melbourne Sat 11 July
Adelaide Sun 12 July
Canberra Sat 1 August
Hobart Sun 2 August
Perth Sat 15 August
Brisbane Sun 20 September
Sydney Sat 10 October

For more details see www.nhaa.org.au or phone (02) 8765 0071
NHAA 8 CPE points

www.nhaa.org.au

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Conferences and meetings


Natural Products Expo Asia
August 27 - 29, Hong Kong Convention and Exhibition Centre, Hong Kong
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Natural Health Conference & Expo
September 2 – 4, AJC Convention Centre, Randwick, Sydney
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Organic Products Expo – BioFach America
September 24 – 26, Boston, (MA) USA
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Natural Products Expo East
September 23 – 26, Boston Convention & Exhibition Centre, Boston, MA, USA
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ASMI Annual Conference & AGM
November 12, Australian Technology Park, Redfern Sydney
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Panacea 2010
February 3 – 5, 2010 World Trade Centre, Mumbai, Maharashtra, India
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Biofach Germany
February 17 – 20, Exhibition Centre Nuremberg, Germany
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Natural Products Expo West
March 11 – 14, 2010 Anaheim Convention Centre, California, USA
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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


Robert Forbes & Associates regularly conducts training courses for clients in our Glebe office meeting room. Courses are conducted with up to five people from only one client at a time. Courses can be tailored to suit your needs, based on your product types and to address any regulatory issues you may be facing.

Half day (4 hour) courses
   • Overview of the Food/therapeutic/cosmetic interface
   • Cosmetic regulation
   • Advertising code
   • Researching levels of evidence for product claims and indications
   • TGA online applications
   • Finished product specifications

Full day courses
   • Food Standards

For more information visit the RFA website

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