Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

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 

 

Raw Potential? New Zealand Opens Raw Milk Regulations Review for Consultation

The New Zealand Ministry of Primary Industries (MPI) has launched an online survey seeking public consultation on the efficacy of current regulations surrounding raw milk.   Source (Copyright): Pearly Neo, Food Navigator-Asia  NZ raw milk

Formulated Supplementary Sports Food Ingredient Restrictions Have Been Updated

As reported in the February 2019 edition of this newsletter under the story heading “Importers of Formulated Supplementary Sports Foods Receive Warning”, some formulated supplementary sports foods currently being imported are not compliant with the Australia New Zealand Food Standards Code (the Code) and may pose a risk to human health. As an update to this story, importers of Supplementary Sports Foods are now advised that 1,4-dimethylpentylamine (DMPA) and Phenpromethamine have been added to the list of substances considered to pose a risk to human health, when found present as an ingredient in formulated supplementary sports foods.   Source: SSF ingredient update

FSANZ Invitation to Have Your Say on Australia’s Food Safety Management Standards

Food Standards Australia New Zealand (FSANZ) has released an information paper on its proposed approach to a review of food safety standards in the Food Standards Code. The review will focus on the requirements for food safety management in the food service sector and closely related retail sectors, and potential development of a primary production and processing standard for high-risk horticulture products to introduce requirements to manage food safety on-farm, including requirements for traceability.  FSANZ has extended the deadline which is now 14 June 2019.    Source: Food safety review

FSANZ Calls for Comment on Minimum Protein in Follow-On Formula

Food Standards Australia New Zealand is calling for comment on an application to reduce the minimum protein requirement for milk-based follow-on formula in the Australia New Zealand Food Standards Code (the Code). Follow-on formula is suitable for infants aged 6 to less than 12 months and is intended to be consumed with complementary food, not as a sole source of nutrition.   Source: Follow-on formula

FSANZ Launches 3rd Biennial Stakeholder Survey

FSANZ Chief Executive Officer Mark Booth said the stakeholder survey measures satisfaction with FSANZ’s performance and explores understanding of FSANZ’s role in the food regulation system. “As always we are seeking responses from all our stakeholders but we are particularly keen this year to expand our reach to small and medium-sized food businesses,” Mr Booth said. “Our stakeholders play an extremely important role in the development of food standards and in other work FSANZ undertakes, so it’s important for us to know how they think we are performing in our key role of developing food standards.”    Source: FSANZ survey

FSANZ Notifications—

Application A1102 – L-carnitine in Food: ​The purpose of this Application is to permit the sale of L-carnitine in a variety of food categories   Source: L-carnitine in food 

Application A1168–Glucoamylase from GM Aspergillus niger as a Processing Aid: The purpose of the Application is to permit the use of glucoamylase produced from a genetically modified strain of Aspergillus niger as a Processing Aid.   Source: Aspergillus enzyme

Application A1176 – Enzymatic production of Steviol Glycosides: The purpose of this Application is to seek approval for a new specification for steviol glycosides produced by an enzymatic bioconversion method using enzymes derived from genetically modified strains of Escherichia coli    Source: E. coli enzyme 

Proposal M1016 – Maximum Residue Limits (2018) : The purpose of this Proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities.   Source: MRL revision

 

Imports Still Impress: Survey Reveals Chinese Consumers Place Premium on Overseas Supplements

More than half (53.7%) of the Chinese consumers surveyed said they bought imported nutrition supplements, while only 7.9% preferred to buy local products, according to a white paper released by the Chinese Nutrition Society.    Source: (Copyright) Tingmin Koe, Nutra Ingredients-Asia China prefers

 

Quote for the month:

“The best time to plant a tree was 20 years ago. The next best time is today”    Chinese proverb

Naturally Good Expo Coming to Sydney in June 2019

Attention to all of our colleagues and customers from outside Australia! This might be just the business opportunity you’ve been waiting for to visit sunny Sydney, Australia. Naturally Good Expo is not open to the public and is ‘trade only’. It’s a total business event that’s 100% devoted to all things healthy, organic and natural. As the largest annual event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. RFA Regulatory Affairs has enjoyed being an exhibitor at Naturally Good Expo in previous years and once again we will be part of the action, helping to support our industry. Plan your calendar now. This is your chance to not only get a first-hand look at the current state of our industry in Australia but also a wonderful opportunity to meet with colleagues and friends down-under. Make sure to call in to our Booth #B43 to chat with us about your latest plans.

 

Early Regulatory Changes Affecting Chemical Importers and Manufacturers Now in Affect

Whilst the new scheme will begin on 1 July 2020, early regulatory changes are now in effect under the current scheme (NICNAS). These changes will reduce the regulatory burden for introducers of some lower risk chemicals such as polymers of low concern. The following changes are now in effect: no more annual reporting for permit holders and self-assessed assessment certificate holders; shorter timeframes for Approved Foreign Scheme assessments; polymers of low concerns (PLCs) are exempt from notification; expansion of the PLC criteria; changes to the definition of a new synthetic polymer; and no more Safety Data Sheets (SDS) and labels required for cosmetics introduced at low volumes.   Source: NICNAS reforms

 

TGA Issues Guidance for TGO 101 (Standard for tablets, capsules and pills)

This guidance includes clarification on, and information relating to, mandatory requirements. It also includes additional information to assist medicine sponsors in meeting their obligations and best practice recommendations. This information may also assist other stakeholders to understand how sponsors and manufacturers assure that medicines that are tablets, capsules or pills are of good quality. When the words 'must' or 'required' are used, a legal requirement is being described. The TGO 101 requirements that apply to pills commence on 31 March 2021.The delayed commencement allows sponsors two years to update their manufacturing documentation and ensure that their goods will comply with the new requirements.   Source: TGO 101 guidance 

TGA Issues GMP Clearance Guidance

This guidance is for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine intended for supply in Australia.   Source: GMP clearance

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 previous month’s 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.

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 Updates 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 April 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019. A total of 16 changes have been made in the updated Determination. These changes include: Addition of 8 new ingredient entries; and changes to 8 existing ingredient entries, including making requirements clearer and less restrictive. For more details go to: Permissible ingredients update

TGA Consultation: Proposed New Medical Device Classification for Substances Introduced Into the Body via a Body Orifice or Applied to the Skin

Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device’s intended use. The TGA periodically reviews classification rules for medical devices to ensure they continue to be appropriate. When undertaking such reviews, the TGA has regard among other things, to the international best regulatory practice and any emerging issues. This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification.    Source: Medical devices consultation

TGA Consultation: Proposed Amendments to the Poisons Standard (SUSMP)

The TGA is inviting comment on The Poisons Standard which is also referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Of particular relevance to some suppliers of complementary medicines are the proposed changes related to *arbutin and sanguinarine from Sanguinaria Canadensis ('bloodroot'). This consultation closes on 13 May 2019.    Source: SUSMP consultation    (Editor’s note: *Arbutin is a constituent of a number of herbs, however the scheduling has particularly affected the supply of herbal preparations of Bearberry (Arctostaphylus uva ursi) and Damiana (Turnera diffusa)).

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

Meizitang Botanical Soft Gel Capsules: contain the undeclared substance Sildenafil & Sildenafil N-Oxide.

JOYSMI Capsules: contain the undeclared substances sibutramine, phenolphthalein and frusemide.

X Power 3 Tablets: contain the undeclared substance Sildenafil.

BMSW 4600MG Black Ant Capsules: contain Sildenafil.

Double Maxx D.B.M. Capsules: contain Sildenafil.

Japan Tengsu tablets: contain Sildenafil.

Magnum XXL Capsules: contain the undeclared substance Tadalafil.

Horny Little Devil Capsules: contain both Sildenafil and Tadalafil.

Lotus Flower Capsules: contain a derivative of fenfluramine. (Fenfluramine is a prescription-only (S4) synthetic anorexic drug, which is no longer available for sale in Australia following its withdrawal from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension were associated with its use).

TGA Safety Advisory - Fallopia multiflora (he shou wu)

Fallopia multiflora (also called Polygonum multiflorum, Fo ti, Reynoutria multiflora and Chinese fleece-flower root) is a herb, also known by the Chinese name 'he shou wu'. Although it is still permitted for use in listed medicines in Australia Fallopia multiflora has been associated with a low risk of liver damage in rare cases. As a consequence, it is a requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: 'Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.' The TGA has received reports of nine cases of liver damage in consumers taking products containing Fallopia multiflora, in the period spanning 2008 to 2018.    Source: fallopia-multiflora-he-shou-wu

Significant Decrease in the Amount of Codeine Supplied to Australians

The up-scheduling of codeine to a Prescription Only Medicine (Schedule 4) in February 2018 has resulted in a significant decrease in the amount of codeine supplied to Australian patients. The decision to up-schedule codeine products to prescription only was taken after evidence showed that medicines containing low-dose codeine combined with paracetamol or nonsteroidal anti-inflammatory drugs (NSAIDs) - such as ibuprofen or aspirin - were generally no more effective than other non-codeine medicines. The codeine-containing combinations were also associated with a number of health risks including addiction leading to misuse, liver damage, gastrointestinal perforations, blood potassium imbalances and respiratory depression. These risks were judged to be too high for the codeine combination products to be supplied without oversight from a doctor.    Source: Codeine consumption drops

Thinking of importing a medicine for personal use in Australia?

Answer: Yes, you can! Provided all appropriate rules are followed, you can import many medicines for personal use.  This includes some medicines that have not been approved for supply in Australia. Usually, it depends on the ingredients in the medicine. There are more restrictions on higher risk ingredients such as ingredients with potential for abuse. This article from the TGA, explains the rules around importing medicines for personal use, including how to find out whether you will be able to import a particular product.    Source: Personal use importation

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

The TGA requires that any therapeutic product supplied in Australia must 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 potentially become a conflict of interest.  The Australian sponsor/distributor controls the product registrations and can cancel or amend them at any time. The sponsor also has access to confidential product information held by the TGA. RFA Regulatory Affairs can help you set up your own independent Australian sponsor company.

Consumer Story: Tim and Selective Androgen Receptor Modulators (SARMS)

Selective androgen receptor modulators (SARMs) are a group of experimental, prescription-only medicines sometimes used illegally by bodybuilders. People who use SARMs purchased online risk their health because SARMS haven't been approved for human use (they are still being researched, and have documented health risks), they are an illegal medicine sold online and may not contain what the seller says it will (It could contain other, potentially dangerous ingredients, or a different dose to the one on the label), and access to SARMs without a valid prescription, license or authority is illegal, and in some cases may result in fines and/or jail time. SARMs also require a permit to import. Tim's story explains the risks of using SARMs, and how to find reliable information about the safety, effectiveness and legality of a medicine. Read Tim's story here: Tim's story

TGA Suggests Three Questions to Ask Natural Health Practitioners About Testing Services

If you are thinking about visiting a natural health practitioner for a diagnosis, some practitioners may offer to diagnose a range of health conditions using tests like live blood analysis, bioresonance, electrodermal testing or hair analysis. Before you consent to this type of test, it's important to do your research about the test and the practitioner offering it. Here are three questions to get you started. Who is conducting the test? Is the test conducted in an accredited laboratory? What are the risks?    Source: Three questions

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