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TGA Reminder to Cancel Unnecessary ARTG Entries to Avoid Annual Charges 

Sponsors are reminded that if they are no longer supplying a product they can cancel their entries from the ARTG before 1 July 2015 if they do not wish to incur an annual charge for those entries in the 2015-16 financial year. Source:


TGA Aims to Improve Clearance Application Process for GMP 

The Therapeutic Goods Administration has experienced a significant increase in the total number of GMP Clearance Applications for overseas manufacturers, from approximately 2500 in 2010 to more than 4000 in 2014/2015. To improve TGA's ability to meet demand, processes are being reformed. The reforms include the collection of performance data which will enable better understanding of the inefficiencies involved. Stakeholders are invited to comment.  Source:


FSANZ Reports on Hepatitis A Risk in Imported Ready-to-Eat Berries 

Food Standards Australia & New Zealand has completed a risk statement on hepatitis A virus and imported ready-to-eat (RTE) berries. This statement has been given to the Department of Agriculture which is the enforcement agency for imported food.   Source:


All You Need to Know About Nutrition or Health Claims for Foods 

FSANZ has issued a guide to complying with the Nutrition, Health and Related Claims Standard of the Australia New Zealand Food Standards Code. Easy to read with simple flow charts, this PDF document is a valuable resource for anyone considering enhancing their food product with specific claims.  Source


TGA Issues Safety Advisory for Slim Fit capsules 

The Therapeutic Goods Administration warns that Slim Fit Capsules contain the prescription drug Sibutramine, which was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke.   Source:


TGA Releases Latest Edition of The Poisons Standard (The SUSMP) 
The Poisons Standard has been presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia and is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). SUSMP No.7 is the current edition and is known as Poisons Standard June 2015.  Source:


FSANZ Application A1090 - Voluntary Addition of Vitamin D to Breakfast Cereal 

Food Standards Australia New Zealand has assessed an application made by DSM Nutritional Products Australia Pty Ltd to permit the voluntary fortification of breakfast cereals with Vitamin D3 and to permit a maximum claim of 2.5 µg per normal serving of breakfast cereals as purchased. Source:


FSANZ Calls for Submissions on Genetically Modified Corn Line 

Food Standards Australia New Zealand today called for submissions on an application to allow food derived from a genetically modified corn line. The corn line had been genetically modified to be tolerant to the herbicide glufosinate ammonium, and for protection against common corn pests. The closing date for submissions is 6pm 14 July 2015.  Source:


India’s Food Safety and Standards Authority Pulls Maggi Instant Noodles from Shelves 

INDIA’S food safety regulator has banned Nestlé from making and selling its hugely popular Maggi instant noodles, calling them “unsafe” and “hazardous” after tests found they contained excessive lead. The Food Safety and Standards Authority of India (FSSAI) said it was ordering Nestle to halt manufacturing after tests by some states found lead levels above statutory limits. An FSSAI statement said it was ordering Nestle India to “withdraw and recall all the nine approved variants of its Maggi Instant Noodles from the market ... and stop further production”. Nestle, which says the lead content in its Maggi noodles is well below the limit, had already announced it would withdraw the product from sale as it tries to contain the growing scandal.  Source:


TGA Safety Advisory: Ja Dera 100% Natural Weight Loss Supplement Capsules 

Ja Dera 100% Natural Weight Loss Supplement capsules pose a serious risk to your health and should not be taken, as they contain the undeclared, prescription-only substance,sibutramineSibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke. The supply of Ja Dera 100% Natural Weight Loss Supplement capsules is illegal.  Source:


The World of Regulatory Convergence: an Australian Reflection 

This presentation was delivered by Prof John Skerritt at the 2015 ARCS Scientific Conference. It provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods. Although this discussion focuses on medicines and medical devices, it does give an insight into the direction that regulations in general are going in this country. Source:


FSANZ Application A1107 - Asparaginase from Bacillus subtilis as a Processing Aid (Enzyme) 

Food Standards Australia & New Zealand is considering permitting the use of a new microbial source for Asparaginase sourced from a genetically modified strain of Bacillus subtilis for use in food production to reduce the risk of acrylamide formation. Written submissions close 6pm (Canberra time) 31 July 2015.  Source:


TGA Advises Changes to the Advertising of Folic Acid 

The Therapeutic Goods Administration now provides for an advertising exemption with regard to Folic acid (minimum recommended daily dosage of 400 micrograms), to the effect that the goods may help to prevent neural tube defects such as spina bifida and/or anencephaly.  Source:


TGA Advises Changes to the Advertising of Calcium 

The Therapeutic Goods Administration now provides for an advertising exemption with regard to Calcium (minimum recommended daily dosage of 290 mg of elemental calcium), to the effect that the goods may assist in the prevention of osteoporosis when dietary intake is inadequate.  Source:


FSANZ Proposal P1037 – Amendments Associated With Nutrition Content & Health Claim 

The purpose of this Proposal is to address inconsistencies and lack of clarity associated with previous standards and also to provide exemptions for certain Health Star Rating label elements.  Source:


ACCORD Responds to NICNAS Streamlining Initiative 

Accord Australasia, the Australian hygiene, cosmetic and specialty products industry body, welcomes the Government’s commitment to reducing unnecessary regulatory burdens arising from the chemicals regulatory framework as announced recently. Accord Executive Director Bronwyn Capanna has said, “Everyday products have been the losers under the current regulatory system which is poorly targeted and treats chemical ingredients of low hazard in much the same manner as those of high hazard”.  Source: Acccord Media Statement


Special Report – Changes to Low Value Turnover Scheme 

On 1st July 2015, the TGA will roll-out the new Annual Charge Exemption (ACE) scheme that will replace the Low Value Turnover (LVT) scheme. An exemption with the ACE scheme is only applicable to those with $0 turnover. The TGA have advised that they have informed sponsors who pre-qualify for the ACE scheme based on the information the sponsors provided for the LVT scheme. All new entries from the 1st May 2015 will automatically be granted an exemption until it is declared that turnover has commenced. Once turnover has commenced, an annual charge will be applicable each year until the product is taken off the register. Sponsors must declare between the 1st and 22nd July each year (starting in 2016) if there was NO turnover in the previous year. If they do not declare $0 turnover, they will be invoiced for the current and previous financial year. An important point to note is that annual charges will now be due by 15th of September each year, where it was previously 1st of October. There is a new option of a waiver of the annual charge on the basis of public health risk/financial viability, which is available for AUST R, biologicals, medical devices of class IIa, IVD class II and above.  Source:

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