TGA Fees and Charges Summary from 1 July 2019

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. A complete list of the new fees and charges that come into effect from 1st July 2019 can be read here: FY 2019/2020 TGA fees

TGA Lists Important Dates for Suppliers of Complementary Medicines

May 2019 - TGA notifies of fees and charges for 2019-20 (becoming effective from 1 July 2019);

1 July to 22 July 2019 – Period for sponsors to submit their declarations of $0 turnover for any relevant ARTG entries;

1 August 2019 – Annual charge invoices for all non-exempt ARTG entries will be issued;

15 September 2019 – Deadline to pay annual charges invoices.   

TGA Safety Advisories—  

Hair Tonic and Hairpro Capsules: Global Therapeutics, following a safety investigation by the TGA, is recalling all batches and all pack sizes of its Fusion Hair Tonic and Oriental Botanicals Hairpro capsules, due to the risk of liver injury. The recalled products all contain the same ingredients, including the herb Fallopia multiflora. The TGA previously published a safety advisory regarding the potential for liver injury in people who consume products containing Fallopia multiflora, as we reported in the April 2019 edition of this newsletter. The TGA has received 15 reports of liver-related adverse events since 2014 associated with Fusion Hair Tonic and Oriental Botanicals Hairpro, including six cases with markers of severe liver injury. The liver injuries led to hospitalisation in three cases. To date, all cases reported in Australia have either improved or resolved after discontinuation of the product. While the risk of drug-induced liver injury is low, it has the potential to be life-threatening.   Source: Hair-Pro hazard

Vitex agnus-castus - potential for interaction with oral contraceptives: Vitex agnus-castus is mostly marketed for menstrual disorders, including symptoms of premenstrual syndrome and/or menopause and acne and is permitted for use in listed medicines in Australia. The TGA has received one report of an unintended pregnancy following concurrent use of Vitex agnus-castus and norethisterone, a progesterone-only oral contraceptive pill. One other similar case has also been reported internationally. Health Canada and the European Medicines Agency (EMA) advise consumers to consult a health practitioner prior to using Vitex agnus-castus-containing products if they are taking hormone-containing medications such as progesterone preparations, oral contraceptives or hormone replacement therapy. Vitex agnus-castus is also known as Chaste Tree, Chasteberry and Monk's Pepper.   Source: Vitex / Pill interaction

University of Sydney Pulls Claims that Elderberries Can Fight Flu

One of Australia’s leading universities has been forced to retract a claim its study showed eating elderberries could help beat the flu after admitting it was overhyping its own science. The University of Sydney also concealed the research was part-funded by company Pharmacare - which sells elderberry-based flu remedies - at the company's request.   Source: Liam Mannix, SMH Elderberry abuse

TGA Continues Action Against Peptide Clinics Australia for Alleged Advertising Breaches

The Federal Court has granted leave to the Secretary of the Department of Health to continue court proceedings against Peptide Clinics Australia (Peptide Clinics Pty Ltd) following the company's liquidation in March this year. The Secretary commenced proceedings in November last year for alleged breaches of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2015. The alleged breaches relate to inappropriate online advertisements for 'peptides' and other prescription-only products. In Australia, advertisements for medicines and other types of therapeutic goods must not be misleading and they must not advertise prescription-only medicines to the public.   Source: Court proceedings

Medical Board of Australia Consultation for Doctors Recommending Complementary Medicines

The Medical Board of Australia has released a public consultation paper to seek feedback on options for clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments. This consultation has been extended until 30 June 2019.   Source: Medical doctor consultation

REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Due to the importance of this information we are repeating the story that we placed in recent editions of this  newsletter. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently $820 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

RFA Regulatory Affairs provides training on preparing and reviewing permissible indications for your products so you can make these changes. To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it.

Sigma Healthcare to Face Investor Questions Over Claims it Mishandled Prescription Drugs

Pharmaceutical supplier Sigma Healthcare will face shareholder questions over claims that it failed to properly handle a range of popular over-the-counter and prescription drugs that get processed through its distribution centres. There are concerns that product quality may have been compromised due to improper handling and storage, with current and former Sigma workers saying that prescription medicines used to treat bacterial infections, depression, high blood pressure and diabetes were left out in 30 to 40 degree heat for hours over the summer months.   Source: Handling of medicines

GSK and Novartis Misled Consumers with Voltaren Osteo Gel Claims

The Federal Court has accepted admissions by GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (GSK) and Novartis Consumer Health Australasia Pty Ltd (Novartis) that they breached the Australian Consumer Law by making false or misleading representations in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. GSK and Novartis admitted that from January 2012 to March 2017, they marketed Osteo Gel as being specifically formulated and more effective than Emulgel in treating osteoarthritis related pain and inflammation. In fact, Osteo Gel and Emulgel products are essentially the same. An Australian Competition & Consumer Commission investigation found that despite having the same active ingredients, Osteo Gel was often sold at a significantly higher retail price than Emulgel.    Source: Voltaren collusion

Do You Need an Australian Sponsor for Your Complementary Medicine or Medical Device?

The TGA requires therapeutic products to be supplied by an Australian “sponsor”. The sponsor may be an individual resident in Australia, or an entity incorporated in Australia and conducting business in Australia where the representative of the entity also resides in Australia. The label of any medicine supplied in Australia must include the name and contact details of the Australian sponsor or distributor. For overseas companies, appointing an independent distributor as your sponsor may potentially present a serious disadvantage. Independent distributors may act for any number of companies supplying similar therapeutic products, which can become a conflict of interest.  The Australian sponsor/distributor controls the product registrations and can cancel or amend them at any time and has access to confidential product information held by the TGA. RFA Regulatory Affairs can help you set up your own independent Australian sponsor company.

USA Attorneys General Call for Rationalisation of Banking Laws for Emerging Cannabis Industry

33 States and several USA Territories have decriminalised the medical use of marijuana; some now even allow for recreational usage. Trouble is, cannabis is still listed as prohibited under the Federal Controlled Substances Act. The A-Gs of all of these jurisdictions have written to Congress looking for a solution. Until there is some harmonisation of State-Federal legislation in these areas, Federal banking statutes push all financial transactions into a grey area dominated by cash payments and out of reach for taxation and other regulatory compliance purposes. Industry analysts estimate the 2017 revenue spent on cannabis of $8.3 billion will rise to $25 billion per annum by 2015.     Source: Cannabis law reform USA

(Related story: USA Lawmakers Introduce Comprehensive Marijuana Reform Legislation, the Marijuana Freedom and Opportunity Act, to remove marijuana from the Controlled Substances Act (CSA), thus ending the nearly century-long federal policy of criminalization and prohibition.    Source: Marijuana law reform ).

From High to Health — The Evolution of Cannabis Applications in APAC

Supplements containing cannabidiol (CBD) and functional foods with hemp are among the biggest buzz categories in nutrition right now, but can they become mainstream commercial success stories in the Asia-Pacific region?   Source (Copyright): Cheryl Tay, Nutra Ingredients-Asia CBD in APAC 

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