When Does Disease Education Stray Into Product Promotion?

This TGA guidance is to assist providers of disease education activities (including sponsors, health professionals, pharmacies, peak organisations and community educators) to ensure that disease education activities do not inadvertently become advertisements for therapeutic goods. While a disease education activity may legally make reference to a range of treatment options, if the information provided is likely to encourage consumers to seek to obtain a particular good, or seek a prescription for a particular medicine, then it will be considered an advertisement.    Source: Education V Promotion

Are You A Business Involved with Medicinal Cannabis Products but Unsure How to Advertise?

This TGA guidance aims to assist providers of medicinal cannabis products and therapies (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) to comply with the therapeutic goods advertising restrictions. The focus of this guidance is to help providers understand how to promote their business or service without advertising medicinal cannabis products to the public, which is prohibited.   Source: Medicinal cannabis advertising

TGA Provides Consent to Supply Therapeutic Goods that Don’t Comply With New Label Laws

The TGA has established a process for sponsors of non-prescription medicines (which include complementary and OTC medicines) to request consent for non-compliance with the new TGO No. 92 - Standard for labels of non-prescription medicine, relating to the presentation of the name of the medicine on product labels. This is an interim measure to assist industry to transition to the requirements for TGO 92. This new order includes requirements to ensure easy readability and identification of key health information such as active ingredients.   Source: TGO 92 consent for non-compliance

Advertising of Complementary Medicines: Update

The Complementary Healthcare Council of Australia (CHC) is no longer accepting any new applications for advertising pre-approvals of complementary medicines (CMs). Applications received by CHC before 14 November 2019 will continue to be processed and decided, with final decisions for all these applications to be made by 27 January 2020. From 19 November 2019, all new applications for approval of medicines advertising in any specified media (broadcast, print, cinema or public display) should be lodged with Consumer Healthcare Products Australia (CHP Australia), which was previously known as the Australian Self Medication Industry. These new arrangements will apply until the pre-approval process is disbanded on 30 June 2020. Application fees will not change from those already published on the website.   Source: CM advertising update

Summary: Therapeutic Goods Determinations

Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Registration) Determination 2018: (Sets out the kind of information which must accompany an application for the registration of a complementary medicine, and the form in which the application must be submitted).

Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Section 26AE Listing) Determination 2018: (Sets out the kind of information which must accompany an application for the listing of a complementary medicine under section 26AE of the Therapeutic Goods Act 1989 and the form in which the application must be submitted).

Therapeutic Goods (Permissible Indications) Determination (No.2) 2019: (Specifies the indications that are permitted for use in a medicine listed in the Australian Register of Therapeutic Goods under subsection 26BF of the Therapeutic Goods Act 1989 and any requirements associated with their use in such medicines).

Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019: (Determines those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods ("the Register") under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines).  

Update to Listed Medicine Ingredients

Therapeutic Goods (Permissible Ingredients) Determination (No. 3) has recently been registered on the Federal Register of Legislation. A total of 40 changes have been made in the updated Determination. These changes include: Addition of 6 new ingredient entries; and changes to 34 existing ingredient entries to make requirements clearer and less restrictive.    Source: TGA updates LM ingredients

Consultation: Are Sports Supplements Foods or Therapeutic Goods? CMA Responds

In the October 2019 edition of this newsletter we ran a story with the heading ‘Consultation: Are Sports Supplements Foods or Therapeutic Goods?’. Complementary Medicines Australia has released a major Position Statement regarding this proposed change to legislation, highlighting concerns that may force some current ‘foods’ to be reclassified as ‘medicines’. CMA believes that probably 40% of ‘foods’ in the specialty sports supplement sector may be affected, with a possible cascading or “domino” effect of around 60-80% of products due to other factors such as inability to access manufacturing lines that are licensed under the TGA requirements.    Sources: TGA sports food consultation; &   CMA position statement; & Media comment

Communique: Therapeutic Goods Advertising Consultative Committee

The fourth meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) was held in Canberra on 17 October 2019. TGACC members represent a diverse range of stakeholders with an interest in the advertising of therapeutic goods, including consumer, industry and health professional bodies. Topics covered included: work on improving granularity of complaints data against Key Performance Indicators; guidance documents on advertising requirements (specifically for providers of medicinal cannabis products), human cell and tissue products and disease education activities; testimonials and endorsements (including the role of social media influencers); and the role product samples.    Source: TGACC communique

The Importance of Approved Terminology for Therapeutic Goods

The TGA develops and maintains approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). This provides a consistent and standardised method for naming of: ingredients; components; routes of administration; dosage forms; container types; units of expression; and proportion.    Source: Approved terminology

TGA Rules on Products Containing Folate

Clarity has been provided that certain goods containing folate, which are represented as being foods for "special medical purposes" or dietary management, are considered to be therapeutic goods. This is due to the high likelihood that these goods may be used for a therapeutic purpose, i.e. to prevent, cure or alleviate folate deficiency or depression, or an inborn error of folate metabolism. This means they must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) and regulated accordingly.   Source: Folate substances

Changes Made to Propolis and Royal Jelly in Listed Medicine Applications

The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Registry of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. This guidance does not apply to ‘Export Only’ medicines. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry.    Source: Propolis & royal jelly

Beware the ‘Barbie Drug’: The Dangers of Using Melanotan

The TGA urges consumers to steer clear of products containing 'melanotan'. These products are usually marketed as injectable tanning products. They are not included on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed for quality, safety or efficacy by the TGA. It is illegal to advertise and supply these products, and their use has proven serious side effects that can be very damaging to one's health (darkened skin, increased moles and freckles, nausea, vomiting, loss of appetite, flushing of the face, involuntary stretching and yawning, and spontaneous erections!). Melanotan and melatonin (which is commonly used as a sleep aid) are different substances, and the above warnings do not apply to melatonin.    Sources: TGA melanotan warning & Lauren Golman, A Current Affair: ACA melanotan story

TGA Safety Advisories- Source: TGA current year alerts

Grakcu capsules: The capsules contain the undeclared substances Sildenafil and Tadalafil

Me2Shape capsules: The capsules contain the undeclared substance Fluoxetine

De2Xy capsules: The capsules contain the undeclared pharmaceutical substance Bisacodyl.

Ying Da Wang tablets: The tablets contain the undeclared substance Sildenafil.

RFA Breaking News

Complementary medicines ('Dietary supplements')

  When Does Disease Education Stray Into Product Promotion? This TGA guidance is to assist providers of disease education activities (including sponsors, health professionals, pharmacies, peak organisations and community educators)…

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Foods

  Proposal to Prohibit the Retail Sale of Pure and Highly Concentrated Caffeine Products As previously reported in the July and September 2019 editions of this newsletter, there has been…

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Cosmetics and TGA Listed Sunscreens

There is no Cosmetics news to report this month, but if you haven’t already seen it, you might like to view: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)

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Marketing News:

  General Interest: Vaccines - Inoculating Against Fear Along with good nutrition and public sanitation, vaccination is one of the most effective ways to prevent diseases. In Australia, the Therapeutic…

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Complementary medicines ('Dietary supplements')

  Country of Origin Labelling for Complementary Medicines Consultation In February 2017 amendments were made to the Country of Origin Labelling (CoOL) laws that changed the basis for being eligible…

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Foods

  Amendments to Imported Food Regulations Recent changes to the Imported Food Control Regulations 2019 take effect on 1 October 2019 and will impact on the operation of the Imported…

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