TGA Publishes Online Catalogue of Permitted Ingredients for Use in Listed Medicines

The TGA is pleased to announce that an online catalogue of ingredients approved for use in listed medicines has been finalised and is now available. Listed medicines can only contain certain low risk ingredients in acceptable amounts that are approved by the TGA. The ingredients available for use in listed medicines and requirements associated with their use are specified in the Permissible Ingredients Determination.   Source: Permiited ingredients

TGA – CMA Bilateral MeetingThe Therapeutic Goods Administration bilateral meeting with Complementary Medicines Australia was held on Friday 24 February. The annual bilateral meeting is a chance for industry associations to meet with TGA executives to discuss the business performance and financials of the previous year, the budget forecast and proposed increases to fees and charges. This meeting also provides a chance for CMA to provide an industry update on its strategic outlook, achievements and issues. A summary of the main updates is provided here:   TGA - CMA meeting  

 

TGA Safety Advisories -

Australia Kangaroo Essence Tablets; & Africa Black Ant capsules; & Nangen Zengzhangsu capsules - The Therapeutic Goods Administration (TGA) has tested these products and found that the tablets and capsules contain the undeclared substance sildenafil (active in Viagra)   Sources: Jump! & Bite! & Rise!

Counterfeit Tadalafil 100mg Tablets - The TGA has tested a product labelled Tadalafil 100mg tablets and found that the tablets contain trace amounts of the undeclared substances sildenafil (active in Cialis) and dipyrone (an analgesic, no longer sold in Australia due to links to a rare but sometimes fatal condition called agranulocytosis.   Source: Fake Cialis

Placebo Tablets - The TGA has tested a product labelled Placebo and found that the tablets contain the undeclared substance clenbuterol (bronchodilator).   Source: Fake Placebo

Change Me Herbal Slimming capsules; & Ultimate & Herbal Slim Weight Loss Capsules; & Lose Weight Capsules - The TGA has tested these products and found that they contain the undeclared substance sibutramine (active ingredient in Reductil, that was withdrawn in October 2010 after a study showed an increased risk of major cardiac events).   Sources: Slim chance & Fat chance & Lose it caps

TGA Releases Medical Devices Safety Update

Health facilities may have justifiable reasons for not following advice given by a medical device sponsor during a product recall, but it is important to document the risk assessment leading up to the decision. A facility declining to implement a recall should complete a well-reasoned risk assessment that is endorsed by the appropriate executive within the facility and stored for future reference. Suppliers may be surprised to learn that some topical creams are classed as medical devices, while others are classed as medicines. According to the Australian medical devices guidance document number 35 'emollient and moisturising preparations, formulated and presented for therapeutic use' are classed as medicines, whereas 'uncompounded emollients, moisturisers presented for therapeutic use' are classed as medical devices. The essential difference is that those topical creams classed as devices achieve their intended action in ways that do not primarily rely on 'pharmacological, immunological or metabolic means'.   Source: Medical device’s

New Zealand Expert Fears Health Product Causes 'Life-Threatening Allergic Reactions'

An Auckland specialist is convinced an over-the-counter health product (herbal ingredient – andrographis) is causing "life threatening allergic reactions" - and her fears have been backed by Medsafe. She skin-tested one patient to determine whether the herb had caused their anaphylactic reaction, but it came up negative. "But that doesn't exclude that it was the ingredient they reacted to - skin testing doesn't exclude a clinically significant allergy. "She reported the drug reactions to New Zealand's Centre for Adverse Reactions Monitoring.   Source: Nicole Barratt, NZ Herald Herb reaction

Read the NPNZ response to the Andrgraphis allergy story here: NPNZ reaction

 

RFA Breaking News

Training Course Update:

NEW COURSE NOW AVAILABLE Pharmacovigilance Obligations Training. For details see foot of this newsletter

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Complementary Medicines (“Dietary supplements”):

  Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 Update. This far reaching bill has implications for those involved in the supply of Listed Medicines, or Medical Devices, as…

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Foods:

  New NZ Government Pulls NHP Bill Regular readers of this newsletter will have noticed the tortuous path of the Natural Health Products bill as it slowly makes its way…

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Cosmetics (& Household cleaning products):

  Correction of an Error on AICS The National Industrial Chemical Notification Scheme (NICNAS) has corrected a listing error on the Australian Inventory ofChemical Substances (AICS), after an entry that…

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Marketing News:

The Seismic Shifts in Marketing’s Role in Direct Selling “Marketing doesn’t matter for a direct selling company.” Have you ever heard this one before? If you’ve been working in direct…

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RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available

Are you new to the Australian market? Are you unsure about how to comply with recent changes to TGA regulations such as the new TGA Order 92? Do you have…

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