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The TGA sought comments from interested parties on the ‘Review of the low value turnover exemption scheme’ in a consultation that closed on 23 May 2014. A total of 44 submissions were received - 35 from TGA sponsors and 9 from peak industry bodies. All submissions that were not marked as confidential are now available in PDF format.
Sales of herbal dietary supplements in the United States increased by 7.9% in 2013, reaching a total estimated figure of six billion dollars for the first time. These statistics are conclusions of a new report published in the current issue of HerbalGram, the peer-reviewed quarterly journal of the nonprofit American Botanical Council (ABC).
American Botanical Council report: http://tinyurl.com/q95bqxd
The TGA has launched a new web-based service to make it easier for consumers to report side effects, also known as adverse events, associated with medicines and vaccines. It is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators.
The National Industrial Chemicals Notification and Assessment Scheme has included ten substances on to the Australian Inventory of Chemical Substances of Cosmetic Ingredients, which had been previously governed by the Therapeutic Goods Administration.
Giving evidence to the NSW Parliament, ‘Inquiry Into the Promotion of False or Misleading Health Related Information’, Complementary Medicines Australia (CMA) questioned the scope of the inquiry and demanded to know with only 10 complaints against the industry - if it was a good use of taxpayer’s money? Detractors have tried to use the Inquiry to attack the Complementary Medicines Industry and Healthcare Practitioners. In a robust statement to the Inquiry Carl Gibson, CEO of CMA warned the Health Commission Inquiry that fringe groups such as Friends of Science in Medicine were trying to drive an agenda against education and research in complementary medicines.
Read all of Carl Gibson’s speech here: http://tinyurl.com/pqwd2ea
Food Standards Australia & New Zealand has received applications seeking approval of new enzymes, serine protease (trypsin & chymotrypsin), sourced from a genetically modified strain of Bacillus licheniformis, as a processing aid in the production of protein hydrolysates.
African Black Ant capsules (contains the undeclared substance sildenafil) http://tinyurl.com/l6u4hft
MMC Sex Men capsules (contains the undeclared substance sildenafil) http://tinyurl.com/lr5j7hq
TGA advises that the supply of these products is illegal. They have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.
This OTC Medicine Monograph outlines the requirements for Australian market authorisation of oral liquid preparations containing pholcodine as a single active ingredient when applied for as an OTC new medicine N2 application. This monograph only applies to pholcodine (CAS no. 509-67-1) as a single active ingredient and excludes preparations containing any salts and derivatives of pholcodine.
A total of 10 submissions were received. Of these, six respondents consented to have their submissions published alongside TGA responses.
A total of five submissions were received. Of these, three respondents consented to have their submissions published alongside TGA responses.
The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.
The TGA is seeking comments from interested parties on any, or all, of the proposed options in the Regulation Impact Statement on the general labelling requirements for medicines, and other related documents. Submissions are invited to include suggested improvements or alternatives to proposed changes; whether or not you support the specific proposals or combinations of proposals; an assessment of how the proposed change will affect you.
Melbourne / Thursday 2nd Oct & Sydney / Tuesday 14th Oct 2014,
The Australian Competition and Consumer Commission is embarking on a campaign scrutinising claims in the marketing of food. Are your claims safe from prosecution? This workshop will help you identify risks in your marketing and how to mitigate and manage these risks but still being able to stand out in the marketplace. This workshop is run by Charles Fisher, a compliance expert presenter from FoodLegal.
Read all of the material presented by TGA officers at this conference. Thirteen topics are available in PDF format. These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the conference. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
Hospitals and chemists could start supplying free, taxpayer-funded cannabis as part of NSW government reforms that will see possession and use of the drug decriminalised for dying patients. Police will be given formal new guidelines “within weeks” ordering them not to prosecute any terminally ill person who is found in possession of up to 15 grams of cannabis. The Australian Medical Association has backed the plans. A number of other states are investigating similar rules and Victoria has announced plans for clinical trials.
News.com.au report: http://tinyurl.com/nlccgas
Body & Health Essentials Maxi Organic Red Grapeseed (L213272) by Body & Health Essentials Pty Ltd was cancelled from ARTG on 15th September 2014.
Read all this year’s product cancellations at: http://tinyurl.com/neua7t9
The Federal Court has declared that Pirovic Enterprises Pty Ltd (Pirovic) engaged in misleading conduct and made misleading representations in its labelling and promotion of eggs as ‘free range’, in proceedings brought by the Australian Competition and Consumer Commission. The Court ordered that Pirovic pay a pecuniary penalty of $300,000 and contribute to the ACCC’s costs.
From January 2012 until January 2014, Pirovic used egg cartons which included the words ‘Free Range’ and images of hens on open pasture. Pirovic admitted, most of its hens did not move about freely on an open range on most days.
Hydroxycitrate complex (AAN) is derived from the fruit rind of Garcinia quaesita Pierre or Garcinia zeylanica Roxb. It contains one or more of the three salts (calcium, potassium or sodium) of hydroxycitric acid. Varying amounts of plant material from G. quaesita or G. zeylanica may still be present in the substance depending on the manufacturing process employed, but should not exceed 10% of the final preparation.
The Council for Responsible Nutrition – International will be holding its Annual Symposium at the Mercure Hotel, Brisbane on 16th October, 2014. RFA Regulatory Affairs will be represented at this symposium by our Senior Regulatory Affairs Associate, Ms. Samantha King. Samantha is well known to our many clients and would love to see you there and discuss any compliance issues that you might have.
The Council for Responsible Nutrition will also be holding its Annual Symposium at the Ritz Carlton, Laguna Niguel, California on 5th – 8th November, 2014. RFA Regulatory Affairs will be represented at this symposium by our Regulatory Affairs Manager, Ms. Kerry Martin. Kerry will be not only attending this symposium but also taking the time to catch up with several of our USA based clients.
CRN-I Brisbane: http://www.crn-i.ch/2014symposium/
CRN Laguna Niguel: http://www.crnusa.org/2014events/