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current affairs

Issue 108 

January - March 2012


Published by Robert Forbes & Associates Pty Ltd. www.robert-forbes.com

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Regulatory Affairs Position at RFA


Latest Regulatory News

TGA lists herbal names to be “corrected”
The TGA has published a list of 110 herbal names using previously approved TGA terminology which need to be “corrected”. The TGA will contact all sponsors to ask for their authorisation to have the TGA correct the names of herbal ingredients in their medicine details currently held on the Australian Register of Therapeutic Goods. The deadline for this is 12 April 2012, and there will be no fee attached to these changes. The full list of names to be corrected is on the TGA website. Sponsors will be required to revise product labels using the new herbal ingredient names.

Submissions invited on draft standard for nutrition and health claims in foods
24 February 2012 - Food Standards Australia New Zealand has called for comment on a draft new standard that would regulate claims made about nutrition content in foods, and claims for a relationship between food and health. This draft contains “refinements” to a previous draft. Particularly, comment is invited on claims for “fat free” and “percentage fat free”. Details at FSANZ website.

MedicineButchery fined $50,000 for false misleading place of origin claims on meat and dairy products
24 February 2012 - After legal action was instigated by the ACCC, Hooker Meats in Victoria admitted to engaging in deceptive conduct by claiming that beef and dairy products were from King Island, when in fact they were not from that region.

Company fined $3.1 million for supplying illegal complementary medicines
14 February 2012 - Export Corporation (Australia) has been fined $3.1 million for supplying medicines that were not included on the Australian Register of Therapeutic Goods (ARTG). The products were nutritional, weight loss and body building supplements. Not only were the products not on the ARTG, but they included undisclosed prescription medicines that pose a significant risk to consumers. The company pleaded guilty to the offences.

TGA publishes compositional guideline for Larix arabinogalactan
14 February 2012 - This ingredient is permitted in listed complementary medicines and the compositional guideline has been published on the TGA website www.tga.gov.au

New guidelines for raw material and packaging suppliers
9 February 2012 - Two industry associations, ASMI and the CHC, have jointly developed new guidelines and questionnaires for suppliers. Copies of the guidelines can be downloaded from the relevant association website: Good Supplier Practice – An Industry Guideline for the Management of Quality Starting and Packaging Materials can be found at http://www.asmi.com.au/industry/Good-Supplier-Practice.aspx and The CHC Guideline for the Quality and Safety of Raw Materials used in Complementary Medicines can be found at http://www.chc.org.au/CHC-Guidelines. The ASMI & CHC Joint Guideline Launch will be held at Rydges North Sydney on Tuesday 22 May 2012, commencing with networking lunch from 12pm and the launch event from 1pm to 3pm. The launch will include an address by a representative from the TGA’s Office of Manufacturing Quality speaking on Supplier Qualification and common deficiencies found at audit; ASMI & the CHC’s Overview of the Guidelines; a range of industry perspectives on the Guidelines; and an expert Industry & TGA Panel. You are invited to attend this launch. To accept this invitation and attend the Joint Guideline Launch, RSVP to Ruth at This email address is being protected from spambots. You need JavaScript enabled to view it. " ' + path + '\'' + prefix + ':' + addy49535 + '\'>'); document.write(addy_text49535); document.write('<\/a>'); //-->\n This email address is being protected from spambots. You need JavaScript enabled to view it. or to Emma at This email address is being protected from spambots. You need JavaScript enabled to view it. " ' + path + '\'' + prefix + ':' + addy11966 + '\'>'); document.write(addy_text11966); document.write('<\/a>'); //-->\n This email address is being protected from spambots. You need JavaScript enabled to view it. , detailing the number of attendees, their names, and their positions in your company.Food

Comments invited on proposed warning statements on cough and cold medications
9 February 2012 - The TGA invites comment on proposed warning statements on cough and cold preparations containing certain types of antihistamines, antitussives, mucolytics/expectorants, and decongestants. The proposed label warning is that the products should not be administered to children under 6 years, and should only be administered to children from 6 to 11 years on the advice of a doctor or pharmacist. Details on TGA website www.tga.gov.au

Joint Australian and New Zealand therapeutics regulator to be phased in over 5 years
8 February 2012 - Health ministers from Australia and New Zealand have agreed on the framework for a joint therapeutic products regulator which will replace Australia’s TGA and New Zealand’s Medsafe, enabling a single approval process for medicines and medical devices for both countries. The first projects to be implemented include a database of adverse reactions and potential safety issues, common recall procedures, a revised process for approval of OTC medicines, and sharing of GMP audit information.

Calls for Warning Labels on Caffeinated Energy Drinks
16 January 2012 - A study published in the Medical Journal of Australia detailing a number of cases of poisoning that have led to hospital admission has led to calls for stricter regulation and warning statements on all caffeinated beverages. Over a period of 7 years in the State of NSW alone, there were 297 reported overdoses with 128 people needing hospitalisation. Symptoms included hallucinations, seizures, cardiac ischaemia, heart palpitations, agitation, tremors and gastrointestinal upset. 25 per cent of calls to the poisons hotline related to a combination of alcohol and energy drinks and another 30 per cent involved stimulants such as amphetamines. Red Bull and V accounted for around two-thirds of the reported cases.

Consumer Guide to Food Labelling Released
11 January 2012 - This gives information on the general labelling requirements for foods and is now available on the FSANZ website. The information applies both to food for retail sale and to food for catering purposes.

Application to have Low-THC Hemp Permitted in Foods
11 January 2012 - FSANZ is assessing an application for approval to use the seed and seed products of Cannabis sativa, with low levels of delta 9-tetrahydrocannabinol (THC), as food. Currently any form of Cannabis is prohibited from being added to food or supplied as a food in both Australia and New Zealand. The applicant is Dr Andrew Katelaris, a medical doctor who has long been an advocate of medical use of cannabis.

Genetically Modified Corn
11 January 2012 - FSANZ has received an application for approval for food derived from corn line 5307, which has been genetically modified for protection against insect pests.

Hotline Established to Provide Information to Women Concerned about Breast Implants
11 January 2012 - The number 1800 217 257 is now available to concerned members of the public, and the TGA has released statements on their website clarifying their current position.

Compositional Guideline for “Natural Fish Oil”
11 January 2012 - The TGA has released a compositional guideline for the listed medicine ingredient “natural fish oil” and this can be viewed on the news section of www.tga.gov.au. The TGA also recognises two BP monographs for refined fish oil, namely “Fish Oil, Rich in Omega-3-Acids” and “Farmed Salmon Oil”, along with the monograph for reconfigured fish oil – “Omega-3-Marine Triglycerides”.

Comment Invited on New Zealand’s Proposed Natural Health Products Bill
11 January 2012 - The bill will replace the Dietary Supplements Regulation and aims to provide a legislative framework for “low-risk natural health products”. The bill is can be viewed on the New Zealand legislation website, and comments are due by 24th February.


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