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

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. (See following story). The key transition dates to note are: 6^th 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 6^th 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

TGA Details Upcoming Changes to Permissible Indications for Listed Medicines

The Therapeutic Goods Administration has detailed the changes that will be made to the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2018 (the 2018 Determination) in February 2019. Since the implementation of the 2018 Determination in March 2018, stakeholders have raised issues that sponsors have encountered when selecting indications for their listed medicines. A Traditional Chinese Medicine (TCM) expert was also engaged to undertake a further review the TCM indications included in the Determination to confirm that they are appropriate for listed medicines. Based on stakeholder and subject matter expert feedback, the Determination will be amended with the changes outlined in this article. The new Determination will be titled the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2019 (the 2019 Determination).   Source: Permitted indications guidance

TGA Guidance: Releasing Medicines Manufactured at Multiple Sites

The TGA has provided technical guidance on the interpretation of the PIC/S Guide to GMP for sponsors or manufacturers of a medicine manufactured across multiple sites. These guidelines will help relevant manufactrurers understand ‘release for further processing (RFFP)’ requirements, and how RFFP fits into the ‘release for supply (RFS)’ process.   Source: Release for supply

TGA Summarises the First Six Months Since New Advertising Reforms Commenced

There have been many important developments in therapeutic goods advertising regulation over the last six months. This update provides a recap of these changes and outlines what the TGA will focus on next. The Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) came into effect on 1 January 2019.    Source: Advertising reforms

TGA Provides GMP Guidance

Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. Australian based manufacturers of medicines are required to hold a licence to manufacture. To obtain a licence, a manufacturer must demonstrate compliance with the relevant code of GMP. This is usually, but not always, done through an on-site inspection. Overseas manufacturers of medicines supplied to Australia are also required to meet an acceptable standard of GMP. If acceptable documentary GMP evidence cannot be provided, the TGA will undertake on-site inspections in the same manner as those conducted for the Australian manufacturers. GMP Clearance is a non-statutory mechanism used to verify that overseas manufacturing sites comply with the principles of GMP for the products being supplied to Australia. A GMP clearance can be obtained per manufacturing site via one of three pathways: a Mutual Recognition Agreement (MRA) desktop assessment; a Compliance Verification (CV) desktop assessment; or, an on-site inspection by the TGA. This guidance decribes an eleven-step process to assist sponsors when applying for a new GMP clearance while also covering the steps for maintaining an existing active GMP clearance.   Source: GMP guidance

TGA Reminds Manufacturers that they are Responsible for Maintaining their Active GMP Clearance

Once a manufacturer has successessfully achieved GMP clearance they are then responsible for maintaining the currency and accuracy of that GMP clearance(s) at all times. Maintaining existing GMP clearances by submitting variation applications allows the manufacturer to keep the original GMP clearance number and to avoid the need to update ARTG entries. Only an existing GMP Clearance can be varied. If that clearance is expired by more than 30 days then it will not be able to be varied via the TGA Business Services portal.   Source: Maintaining GMP clearance

TGA Updates the Advertising Complaints and Investigation Information Database

The TGA publishes the outcomes of all advertising complaints, including the actions taken on the complaint. For complaints in the medium risk category or higher, they publish additional information such as the responsible party and the products involved in the complaint. New search options added to the database make it easier to find information about advertising complaints and investigations.    Source: TGA advertising complaints 

CMA Produces Booklet to Harmonise Industry Response to Skewed Media Reports

Complementary Medicines Australia (CMA) is the peak industry body for the complementary medicines industry, representing members across the supply chain, including manufacturers, importers, exporters, raw material suppliers, wholesalers, distributors and retailers. CMA has developed this booklet in response to some biased, inaccurate and misleading media reporting that may ultimately cause undue concern for the Australian public.    Source: CMA media handbook      (Media example: Channel Nine’s 60 Minutes TV show aired on February 10^th 2019, with a segment titled ‘Trick Or Treatment’. https://www.9now.com.au/60-minutes/2019/episode-2 . The main thrust of the program was on adverse reactions to products that were not listed on the Australian Register of Therapeutic Goods (ARTG) and hence were illegally supplied products; and other adverse reactions which have not been formally reported using the recognised TGA medicines safety monitoring program.)

Australian Company Pays Fine For Illegal Medicine Exports

On 14 December 2018, the TGA issued Australian company, TK Imports Wholesale Pty Ltd, an infringement notice. It is alleged that TK Imports Wholesale Pty Ltd exported unlawful medicines from Australia. These medicines were not included on the Australian Register of Therapeutic Goods (ARTG) or subject to approvals, exemptions or permits. They were also found to contain undisclosed ingredients. The TGA Regulatory Intelligence and Investigations Section (RIIS) confirmed that the alleged exporter was a repeat offender that had knowledge of the therapeutic goods regulatory scheme through previous dealings with the TGA. TK Imports Wholesale Pty Ltd paid the infringement notice in full on 1 February 2019. The investigation is now closed.   Source: Illegal medicine exports

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

Mang Luk Power Slim capsules ; Boxy Indelar capsules ; ISHOU Fulin Ruan Jiaonang capsules ; BASCHI Quick Slimming capsules ; Deli by New Queen capsules – each of thse products contain the undeclared substance *sibutramine.

*Sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). Sibutramine was withdrawn from the Australian market in October 2010 after a study showed an increased risk of major cardiac events.

Beyond Belief: NZ Supplements Sector Staggered as Government Goes Back to Drawing Board

New Zealand’s natural products sector is facing yet another lengthy process of workshops, surveys and consultations to secure regulations that are fit-for-purpose, after the government signalled its intention to go back to the drawing board.   Source (copyright): Gary Scattergood, Nutraingrdients-Asia NZ regulations

Joint Supplement Arthrem's Makers Being Prosecuted By NZ Health Ministry

The company behind arthritis supplement Arthrem is being prosecuted by the New Zealand Ministry of Health. The directors of Promisia Integrative told the sharemarket recently that the ministry was filing nine charges against the company, alleging that Arthrem was being sold as an unlicensed medicine. The ministry also claims some of Promisia's marketing activities breached the Medicines Act 1981. Promisia's chief executive, Rene de Wit, said it disputed all charges.    Source: Catherine Harris, Stuff Arthrem challenged

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Examines Ashwagandha Roots

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program (BAPP) is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The BAPP has released its first publication in 2019, a bulletin on adulteration of ashwagandha roots, and root extracts. Despite its long history of use in Ayurvedic medicine, the primary traditional medicine system in India, the popularity of ashwagandha has increased only recently in the United States, now being one of the top 10 best-selling herbs in natural food stores in USA. Unfortunately, there have been reports of adulteration, primarily by replacing ashwagandha root with undeclared ashwagandha leaf material.    Source: ABC on Ashwagandha

Australian Cosmetic Animal Test Ban Bill Passes Senate

The Australian Senate has recently passed the Government's Industrial Chemicals Bills 2017, including measures to prohibit reliance on new animal test data for chemicals introduced into Australia for use as ingredients in cosmetics. The Ministerial Rules that accompany the bill will prohibit new animal test data for all cosmetic uses of chemical ingredients introduced to Australia.There are further measures to increase compliance with the ban once implemented, as well as measures which extend beyond the cosmetics ban, and will contribute even more significantly to a reduction in animal testing.    Source: HSI Animal testing

Current Developments in Food Law and Policy In Australia and Overseas

Australian law-firm, FoodLegal, has conveniently summarised the latest (February 2019) changes affecting the food industry both locally and overseas. Some of the stories, which you may have already read here and other relevant stories, are all presented with an emphasis on how the law relates to the current supply of foods in various global jurisdictions.   Source: FoodLegal Global food news

Importers of Formulated Supplementary Sports Foods Receive Warning

Importers of formulated supplementary sports foods have been advised that some of the products currently being imported into Australia are not compliant with the Australia New Zealand Food Standards Code (the Code) and may pose a risk to human health. Under section 8 of the Imported Food Control Act 1992, it is an offence to import food into Australia if the importer knows, or ought reasonably to have known, that it poses a risk to human health. The offence carries a penalty of imprisonment for up to 10 years.  Source: Sports food fail

Foot-And-Mouth Disease Detected in Airport Seizures

A disease that could potentially wipe out Australia's multi-billion-dollar livestock industry has been detected at Australian airports. Two detections of foot-and-mouth disease (FMD) since December 2018 were confirmed by the Australian Animal Health Laboratory in meat products declared and seized at airports. The pork jerky, sausages and other pork products were collected by Department of Agriculture staff. The highly contagious foot-and-mouth disease can spread between animals by inhalation, ingestion, and direct contact with the disease and could cost Australia's livestock industries $40-60 billion.   Source: ABC News Foot-and-mouth

January 2019 Failing Food Report

The Department of Agriculture and Water Resources targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at the rate of 100 per cent until a history of food safety compliance is established. When an emerging human health and safety hazard is identified in food, the department may temporarily increase monitoring and testing. This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of August. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, coagulase positive Staphylococci E coli, and Salmonella, as well as the toxins histamine and aflatoxin and more. Source: Latest failed foods

FAQS For Food Businesses

Food Standards Australia & New Zealand has helpful information for all food businesses.   Source: Food FAQs

Strawberry Tampering Incident Report to Government

As reported in previous editions of this newsletter and elsewhere, a food tampering incident occurred involving sewing needles inserted into Australian strawberries in September 2018. Initially an isolated event in Queensland, the incident escalated to other states and territories involving multiple tampering events in strawberries and other fruit across the country. Only a few instances were believed by authorities to be associated with the original event with most other instances believed to be multiple hoax or ‘copycat’ events. This report on these food tampering incidents has been produced by Food Standards Australia New Zealand (FSANZ). The report summarises measures taken by food regulatory agencies, the police and industry in response to the incident, as well as canvassing issues identified by food regulatory agencies, police and industry stakeholders about supply chain vulnerabilities, response procedures and communications.   Source: Strawberry tampering outcome    P.S. In November 2018, a former berry supervisor for one of the affected brands was arrested and charged with the crime in Brisbane, Australia. Her motive was said to be spite over a workplace grievance.

Retail NZ Welcomes Nathan Guy Bill on Food Contamination

Retail NZ has applauded National MP Nathan Guy for proposing a Member’s Bill that will create stronger penalties for deliberate food contamination. “Following on from the many recent incidents in Australia involving needles in fruit, and copycat in New Zealand, Retail NZ and the Food and Grocery Council have asked the Government to create a specific criminal offence relating to grocery sabotage,” Greg Harford, Retail NZ’s General Manager Public Affairs said today. “While the Government has not responded to our request, Retail NZ is delighted that National’s Nathan Guy has proposed a Member’s Bill to deal with this issue.    Source: Scoop Food contamination bill

FSANZ Notifications—

Application A1159 – Triacylglycerol lipase from Trichoderma reesai as a processing aid(enzyme): The purpose of this Application is to permit the enzyme lipase, triacylglycerol from Trichoderma reesei as a processing aid for the production of bakery products and cereal-based beverages. Source: Trichoderma enyme

Application A1172 – Enzymatic production of Rebaudioside D: The purpose of this Application is to seek approval for a new specification for rebaudioside D produced by an enzymatic conversion method.   Source: Rebaudioside D enzyme

Consultation on EU-NZ Free Trade Agreement

The New Zealand Government has called for consultation on lists of geographical indications (GIs) that the European Union is asking New Zealand to protect as part of negotiations for a free trade agreement. The lists include GIs for a range of foods and beverages. Food suppliers with registered trade marks in New Zealand that are similar to the terms on the list, or use any of the terms as common descriptors for goods exported into New Zealand, may wish to make a submission. Submissions are due by the 19 March 2019   Source: NZ-EU food consultation

NZ Company Hellers Prosecuted Over Mispackaged Sausages

New Zealand Food Safety has announced that smallgoods manufacturer Hellers has been fined almost $40,000 and ordered to pay a total of $15,000 to 3 children who had moderate to severe allergic reactions after consuming mispackaged Sizzlers sausages. This is the first time that tougher penalties introduced in the Food Act 2014 have been imposed.   Source: Sausage allergy

Famous Chinese Health Food Brand Stung In Honey Scandal

One of China's most famous health brands, Tong Ren Tang, has been banned from making honey and fined 14 million yuan (AUD$2.9 million), after it was caught "recycling" expired honey into premium label jars for sale in supermarkets. A Chinese television program had found that hundreds of bottles of expired honey were taken to a factory to be repackaged and resold under the Tong Ren Tang label. An official investigation by the Food and Drug Administration later found 2284 bottles had entered the market since October 2018. The blending of adulterated honey from China with Australian honey sparked a backlash against "fake" honey on Australian supermarket shelves in 2018. Australian regulators have not taken action against Australian honey makers accused of selling blended honey, and are instead reviewing testing standards for imported honey. In a separate and recent fake honey case in New Zealand, food safety regulators are taking a company, Evergreen Life, to court alleging its manuka honey product is fake and mixed with artificial chemicals.    Source: Kirsty Needham, SMH Chinese honey

DSA Warns of Dangers in Using Affiliate Marketing

Direct Selling Australia (DSA) is the industry association for direct selling in Australia of retail products. ‘Affiliate marketing’ is a type of performance-based marketing in which a business rewards one or more ‘affiliates’ for each visitor or customer brought by the affiliate's own marketing efforts. Direct Selling Australia is deeply concerned by the legitimacy of some of these models and urges that extreme caution be exercised by anyone looking to join a scheme that claims to use affiliate marketing as the primary form of marketing a product offering. Of particular concern is whether these companies may be misleading and involved in deceptive conduct which is illegal under Australian Consumer Law. Globally, the direct selling industry is committed to preventing illegal activity and to protect individuals from scams. Work is on-going in many jurisdictions to track the use of affiliate marketing models within the direct marketing channel so that best practice guidance can be issued.   Source: Affiliate marketing

Australian Natural Healthcare and Wellbeing Snapshot

The domestic Australian complementary medicine industry is robust and significant . Market research shows that the popularity of complementary medicines is increasing with a growth rate of seven per cent year on year. Three-quarters of Australians, including 92 per cent of women aged 20-24; take at least one complementary medicine and a quarter of the population visit complementary healthcare practitioners each year. In Australia, the fastest growth areas are nutritional oils, men’s health and eye health. Products are manufactured to some of the highest standards in the world based on GMP validation and stringent therapeutic regulations. These standards are maintained by the Therapeutic Goods Administration (TGA) through a transparent approval process, strict manufacturing compliance guidelines and effective post-market monitoring. The TGA register also supports the complementary medicine industry with evidence-based research, monitoring and safety data. These elements combine to allow Australian manufacturers to supply world-class products at globally competitive prices.   Source: Austrade snapshot

Quote for the month:

“Health is a state of mind. Wellness is a state of being”   Anon

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.