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Kate Durey our Regulatory Affairs Manager will be starting maternity leave soon in anticipation of her new arrival. We are really happy for her and wish her new family all the best for the future. Her maternity leave will start from Monday 3rd December. Kate will be returning to the team mid-2013. In the meantime Samantha King will be performing Kate’s role as well as helping to train and mentor our two new regulatory affairs associates, Ellie Ji Yoon Kim and Tina Camilleri.
Latest Regulatory News
TGA appoints new advisory council
The TGA has appointed a group of health care professionals to monitor its performance and communications.
BSE food safety risk assessment reports for the Netherlands, Croatia and Vanuatu
FSANZ has determined that the risk assessments for these countries show that effective controls for BSE are in place. FSANZ has concluded that the risk posed to consumers from the export of beef products from these countries is negligible.
Infant formula requirements - proposed changes
Food Standards Australia New Zealand invites submissions on proposed changes – closing date is 20th December 2012. FSANZ is considering an application to reduce the minimum required level of L-histidine from 12 mg/100 kJ to 10 mg/100 kJ. FSANZ states that this level is comparable to the average L?histidine content of breast milk and is considered adequate to support the growth of formula-fed infants, and the proposed change would provide consistency with international and overseas food standards, and reduce trade barriers. No public health and safety issues have been identified with the proposed change.
Chemical Formulators (ChemForm) admits engaging in Resale Price Maintenance
ChemForm supplies cleaning chemicals to hospitals, hotels, food processors, mining companies and aged care facilities. Chemform admitted that it was likely to have engaged in resale price maintenance by entering into agreements restricting resale prices and withholding supply from a distributor that did not agree to the price specified by ChemForm. ChemForm has entered into a court enforceable undertaking to revise its distributor agreements, not engage in resale price maintenance in the future, and advise their distributors they are free to set the minimum price at which they wish to sell the products.
ACCC not happy with proposed free range egg standards
The claim “free range” could be misleading to consumers as (1) The proposed outdoor stocking densities are very significantly higher than those in existing standards; (2) Only a very small proportion of birds actually venture onto the range at any one time; and (3) The animal management practice of beak trimming is routinely practised. 1700 submissions were received and processed.
Pharmaceutical industry Code of Conduct authorised for 3 years
The ACCC has authorised edition 17 of the code for 3 years. The code regulates interactions between Medicines Australia’s pharmaceutical member companies and healthcare professionals such as doctors and pharmacists. The ACCC stated that the revised code provides greater transparency, but also stated that community expectation of disclosure have increased and continue to increase, and that Medicines Australia “could go further in ensuring the Code meets these expectations now and in the future.”
ACCC launches consumer guidance on country of origin claims
These guidelines help consumers understand the difference between “Product of/Grown in” and 'Made in', and explains that label statements such as 'Proudly Australian owned' or '100% Australian owned' are statements are about the ownership of the company not the origin of the product or its ingredients.
Palm tocotrienols complex compositional guidelines out for comment
The proposed revision of draft compositional guideline for this substance is now on the TGA website and comments are invited – closing date is 19th December 2012.
Advisory statements required on medicine labels updated
Edition 1, update 4, details these statements and is available here
Adulteration of slimming capsules with non-declared prescription medicines
Yet another imported product that is not entered on the Australian Register of Therapeutic Goods has been found to be contaminated. Majestic Slimming Capsules are labelled as being “herbal” yet contain sibutramine, a prescription medicine withdrawn from sale due to the risk of serious cardiovascular events, and phenolphthalein, which was also withdrawn from sale due to serous safety concerns.
New names for some metal amino acid chelates
19 new names have been added for certain metal amino acid chelates. These are ingredients already permitted in listed medicines. The new names can be viewed here. The reference standard for these names is “TGA 2011”.
SPF 50 sunscreens will be available in Australia this summer
Harmonising with regulations in the USA, New Zealand and parts of Europe, the Australian and New Zealand Sunscreens Standard now allows sunscreen products to be labelled with a maximum SPF claim of 50+. The Australian regulatory guidelines for sunscreens (ARGS) have been produced and this replaces Chapter 10 'Sunscreens' in the Australian regulatory guidelines for OTC medicines (ARGOM). The two standards differ in (1) how high an SPF can be on the label, (2) the statistical requirements for the SPF and water resistance tests and (3) the broad spectrum test. More information on TGA website.
Nordoff-Robbins Music Therapy Corporate Christmas Cards
This year Nordoff-Robbins Music Therapy are working with Charity Greeting Cards. Corporate Christmas cards can be designed and ordered online, and 40c from the cost of every card will go to Nordoff-Robbins Music Therapy, who use music to transform lives and bring the benefits of music therapy to those in need. Christmas cards can be ordered at www.christmascards4charity.com.au/nordoff and more information about Nordoff-Robbins can be found at www.nordoff-robbins.com.au
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