Reforms to the Regulatory Framework for Complementary Medicines

In February 2017 the TGA announced a public consultation, ‘Consultation: Reforms to the regulatory framework for complementary medicines: Assessment pathways’. A total of 60 submissions were received. All submissions that gave permission to be published on the TGA website are now available in PDF format.    Source: TGA reforms

Broad Support for New ‘Third Way’ Supplements (Complementary Medicine) Health Claims in Australia: TGA

Australian regulator the Therapeutic Goods Administration (TGA) says there is broad support for plans to introduce a ‘third level’ of health claims for supplements (complementary medicines).    Source: Gary Scattergood+, NutraIngredients TGA 3rd way

Updates to the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in July 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017. A total of 67 changes have been made in the updated Determination. These changes include the addition of 4 new ingredients; Changes to 55 existing ingredient entries; and, the removal of 8 ingredients that have been determined not to be suitable for inclusion in listed medicines. A complete list of changes to ingredient availability is available here: Permissible ingredients

TGA Announces Electronic Signatures to Replace 'Wet Ink' Signatures

All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and no longer contain a wet ink signature. This initiative will position industry for a future move to online self-service.    Source: e-Signatures

TGA Safety Advisories –

V8 tablets; & Sirrori Green Viagra Tablets: the tablets contain the undeclared substance sildenafil    Source: V8 tabs ; Sirrori tabs

Jing Pin Heijin Gang Tablets: the tablets contain the undeclared substances sildenafil and paracetamol    Source: Jing tabs

RUFF Natural Formula capsules: the tablets contain the undeclared substances tadalafil, sildenafil and dapoxetine    Source: Ruff tabs

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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