TGA Launches New Advertising Hub and Online Complaints Form

Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1 July 2018, the Therapeutic Goods Administration launched a web hub bringing together news and information about the regulation of therapeutic goods advertising. This online resource contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting unfair or misleading advertising and submitting enquiries. The new complaint form makes it easy for anyone to lodge complaints about advertisements for therapeutic goods. The TGA is now the sole body for handling complaints about medicine and medical device advertisements aimed at the public, with new sanctions and penalties for advertisers who do not comply with regulations. Consumers can use the hub to educate themselves on the rules that protect them against unfair or misleading ads for therapeutic goods. Fact sheets such as "The top 10 things to look out for in medicine advertisements" explain the controls in place to protect the health and safety of consumers. Advertisers can learn how to meet the requirements of a compliant advertisement through e-learning modules on the hub. The first module on the basics of therapeutic goods advertising regulation is now available, with future modules planned for the coming months. Advertisers can also check whether a particular therapeutic good can be advertised to the public by using a simple online decision tool.   Source: TGA advertising hub (You can also choose to attend one of our training courses specific to advertising: http://www.rfaregulatoryaffairs.com/training-courses)

TGA Provides Medicine Labelling Guidance

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders. There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they're used. In recognition of this, medicine label requirements are specified in two separate labelling Orders: Therapeutic Goods Order No. 91 (prescription), and, Therapeutic Goods Order No. 92 (non-prescription). Transition period ends 1 September 2020.   Source: Medicine labelling (RFA also offers training courses on labelling http://www.rfaregulatoryaffairs.com/training-courses )

TGA Changeover to Therapeutic Goods Advertising Code 2018

The following information is provided for advertisers to explain what will happen in the changeover from the 2015 Code to the 2018 Code. The 2018 Code takes effect from 1 January 2019. On this date, the 2015 Code will be repealed. However, the 2015 Code will still be relevant in some situations. Delaying the date for when the 2018 Code takes effect allows advertisers time to familiarise themselves with it and to bring existing advertising material into compliance. The delay will also allow advertisers to undertake the training and education offered by the TGA.   Source: Advertising code .   Editor’s Note: See the latest updates in two most recent TGA presentations--Code update

TGA Advises on the Future Regulation of Low Risk Products

When the Australian Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applying to a range of products that represent a very low safety risk to consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products, over 1,000 submissions were received in response. The proposed options for reform spanned from retaining the status quo to exclusion or exemption from the therapeutic goods regulatory framework. Following analysis of consultation responses, a range of reform activities have been endorsed by Government. It has been decided that there will be no changes concerning the regulation of water soluble vitamins / minerals, nor sunscreens. However there are changes affecting tampons and menstrual caps, nappy rash creams, and hard-surface disinfectants. Anti-perspirants and ear-candles will become exempt from regulation under this code.   Source: Low-risk future

Australia Leads the Way in Regulatory Standards for Complementary Medicines

Mr Carl Gibson, CEO of Complementary Medicines Australia (CMA) syas that Australia leads the way in regulatory standards for complementary medicines. “Whilst criticism can be healthy, increasingly our industry has become the target of irresponsible and ill-informed commentary that appears to stem from a misunderstanding of the existing stringent regulatory standards that apply to complementary medicines in Australia and the recent regulatory changes that have strengthened regulatory controls even further.” “The fact remains that Australian complementary medicines industry operates within one of the most tightly regulated systems in the world, where products are manufactured to a pharmaceutical standard under Good Manufacturing Practice (GMP), and strict safety and quality regulations are enforced by the Department of Health’s Therapeutic Goods Administration (TGA).” “This regulatory approach demands that manufacturers are licensed and inspected and follow the highest standard of GMP, not only for products for the Australian market but also for those exported overseas.”  Source: CMA media release Vitamins in Australia

TGA's Compliance Review Of Sunscreens

Consumer information - In May 2017, the Therapeutic Goods Administration published the laboratory testing results of 31 commonly used sunscreens. These included lotions, creams and aerosol sprays sourced from Australian pharmacies and supermarkets. All of the products tested contained the levels of active ingredients specified on their labels. Since May, the TGA has completed a desktop review of 94 listed sunscreen products, examining the quality, safety and efficacy of sunscreens on the Australian market. TGA found no compliance deficiencies in relation to quality, safety and efficacy in every-day use of these products. (Background: Last Summer there were many media reports of consumers suffering significant sunburn even after using authorised sunscreens in Australia. Consumers are reminded that suncreens will under-perfrom unless the following advice is followed: Apply sunscreen liberally (at least 1 teaspoon/5 ml) to each area (arm, leg, back, etc.) for full coverage and effectiveness; Re-apply sunscreen regularly (every two hours), especially after swimming or towelling (water activities or activities that may cause perspiration require more frequent application); Sunscreen products do not block 100% of UV radiation. You will become sunburnt if your skin is exposed to the sun for extended periods).    Source: Sunscreen effectiveness

Submissions Received: ‘Options For The Implementation Of A Claimer For Efficacy Assessed Non-Prescription Medicines’

Between 10 May and 21 June 2018, the TGA sought comments from interested parties on the review of Consultation: Options for the implementation of a claimer for efficacy assessed non-prescription medicines. All submissions that gave permission to be published on the TGA website are available online in PDF format. The outcomes of this consultation will be published on the TGA website in due course.   Source: TGA submissions

New Zealand Supplement Rules: New Members' Bill Proposes Raft of New Regulations to Replace 1980s Laws

The long-running saga of proposed new regulations for New Zealand's supplement industry has taken another turn, with a new Members' Bill being laid out in parliament detailing a whole new set of proposals.   Source: Gary Scattergood, Nutra Ingredients-Asia NZ rules

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Need for Seal tablets: the tablets contain the undeclared substance sildenafil.

Gold Maka tablets: the tablets contain the undeclared substance sildenafil

One Night Lover tablets: the tablets contain the undeclared substance sildenafil

RFA Breaking News

New Service From RFA Regulatory Affairs - New Product Development

Details at the bottom of this newsletter.

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Complementary Medicines (“Dietary supplements”):

  TGA Launches New Advertising Hub and Online Complaints Form Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1…

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Foods:

  Australia and New Zealand Ministerial Forum on Food Regulation Communiqué 29 June 2018 The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) met to consider a…

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Cosmetics (& Household cleaning products):

  Accord Australasia Sets Up ‘WashWise’ – All You Ever Wanted to Know About Washing Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic…

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Marketing News:

  When are ‘Naturals’ not Natural? When you’re in Aldi Products marketed by supermarket giant Aldi using the term "naturals" don’t need to be made of mostly natural ingredients if…

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Complementary Medicines (“Dietary supplements”):

  Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 – Update The Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 was registered on the Federal Register of Legislation…

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