RFA Regulatory Affairs - Latest Regulatory Affairs Newsletter

Latest Regulatory Affairs Newsletter

Consultant,

A collection of regulatory news from this month.

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

Special Report: Strawberry Tampering and its Aftermath

This article from Food Legal addresses the February 2019 report by government body Food Standards Australia New Zealand (FSANZ). FSANZ had been commissioned to examine regulatory deficiencies in relation to the Australian horticultural supply chain and food incident response protocols following a major strawberry tampering incident in 2018. This article examines the lack of progress. Source: Joe Lederman, Food Legal Strawberry tampering

FSANZ Conducts Biennial Stakeholder Survey

Food Standards Australia & New Zealand regulates the supply of foods in these countries and wants to know how you think they are performing in their key role of developing food standards, your understanding of their role and how well they are communicating what they do. Please take a moment and complete the survey which should take about 4 minutes: FSANZ survey

FSANZ Notifications—

Application A1160 – Aspergillopepsin I from Trichoderma reesei as a processing aid (enzyme): The purpose of this Application is to seek approval to permit the enzyme Aspergillo-pepsin-I from Trichoderma reesei as a processing aid for the production of potable alcohol products and protein processing. Source: Enzyme

Application A1170 – Rebaudioside MD as a Steviol Glycoside from Saccharomyces cerevisiae: The purpose of the Application is to seek approval for a steviol glycoside mixture (Reb MD) for use as an intense sweetener, produced from a genetically modified Saccharomyces cerevisiae. Source: Sweetener

Premium New Zealand Honey Producer Admits Adding Chemicals

A New Zealand company has pleaded guilty to charges of adding artificial chemicals to its premium manuka honey, in a flagship prosecution over a product that is a high-value export for the country. New Zealand Food Safety filed the case against Auckland-based Evergreen Life, whose products were pulled from shelves in 2016 by the Ministry for Primary Industries, which said they might contain "non-approved substances". Evergreen Life and a company manager, Jason Lee, have pleaded guilty to seven representative charges of selling adulterated honey with intent to deceive for material gain and of selling non-compliant honey. Source: Lidia Kelly, SMH NZ honey dope

Australia Takes Top Spot From USA for Supplements and Health Foods Imported Into China

Australia now accounts for 22.3% of all supplements and health foods imported into China, taking the top spot from the US, which had a 20.4% share of the market in 2018. Source: (Copyright) Gary Scattergood, Nutra Ingredients-Asia Aussies beat USA into China

Importers Beware!

Did you know that anyone in Australia who imports a product, will be deemed to be the manufacturer for the purposes of the Australian Consumer Law (ACL). Even though the importer has not manufactured the product, this law is in place as a matter of public policy to ensure that importers are not importing poor quality products for consumers without the imported products undergoing the proper checks to ensure the product’s safety. In other words, importers of products will be held to the same manufacturer standards which apply here in Australia. To find out more visit IME Insurance

Quote for the month:

“A year from now you will wish that you started today” Anon.

Important Brisbane Conference

The 14th International Conference on Complementary Medicine Research (ICCMR), ‘Pathways to Partnerships’, is being held in Brisbane, Australia over four days on Tuesday 7th May to Friday 10th May 2019. This event is the pre-eminent annual research event for the field convened by Endeavour College of Natural Health in association with the International Society for Complementary Medicine Research and leading research institutions around Australia. Source: ICCMR 2019

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. When you do get here, make sure to call in to our Booth #B43 to chat with us about your latest plans.

NICNAS Seeks Consultation on 2019 Draft General Rules

The National Industrial Chemicals & Notification Scheme is seeking feedback on proposed changes to the new scheme's draft General Rules. This consultation closes 17 May 2019. Source: Cosmetic consultation (Please note: From 1 July 2020, NICNAS will be replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS). Whilst the new scheme will begin on 1 July 2020, early regulatory changes are now in effect under the current scheme (NICNAS)).

TGA Lists Changes to Permissible Indications for Listed Medicines

The list of permissible indications has been updated by Therapeutic Goods (Permissible Indications) Determination (No. 1) of 2019 [the ‘Second Determination (2019)’]. The changes made are organised into 8 tables of items on the TGA website. Of particular interest to suppliers of listed complementary medicines, the TGA have added a number of new indications to choose from; removed some Traditional Indications; and have re-added or changed some label warning statements. Source: Permissible indications

(Editor’s note: Please see following story for more information and important dates regarding changes to the indications and warnings that must be displayed for listed complementary medicines).

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 last 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 provide 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.

Required Advisory Statements for Medicine Labels (RASML)

Australian labelling requirements for non-prescription medicines require some over-the-counter and complementary medicine labels to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines. These advisory statements are set out in the TGA document 'Required Advisory Statements for Medicine Labels' (RASML). The specification sets out required advisory statements for over-the-counter medicines and registered complementary medicines. As an example, the entry for fennel oil reads: "Fennel oil - Conditions: For the purpose of exclusion from the schedules to the SUSMP (in preparations or oils containing more than 5 per cent of methyl-chavicol); and packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert. Required statement: KEEP OUT OF REACH OF CHILDREN". Listed complementary medicines are not subject to this specification as they must comply with the different standard, the Permissible Ingredients Determination (see previous stories for more). Source: RASML 5

TGA Looks at Brexit Implications for Supply of Therapeutic Goods in Australia

In examining the possible implications of Brexit for the supply of therapeutic goods in Australia, the TGA has detailed the consequences of different scenarios. In the event of a 'no deal' exit of the United Kingdom (UK) from the European Union (EU), the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia. If there is a 'no deal' Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. There will be no impact on the supply of medicines to Australia from the UK. If there is a Brexit 'deal' or exit extension, then under the proposed Brexit 'deal', UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will also be no immediate impact on manufacturers certified by these notified bodies. Source: Brexit implications

TGA Provides Application and Submission User Guide for Listed and Assessed Listed Medicines

The TGA Business services (TBS) portal provides an electronic facility for the listing and registration of medicines on the Australian Register of Therapeutic Goods (ARTG). There are two pathways for listing a medicine in the ARTG: AUST L listed medicines which are listed in the ARTG after self-certification by sponsors that all legislative requirements are met; and AUST L(A) assessed listed medicines which are listed in the ARTG after self-certification of quality and safety of the product and pre-market assessment for efficacy evidence to support the product indications. The Act allows for cancellation of a product from the ARTG if a sponsor's certification is incorrect. Source: User guide

TGA Explores Hosting a 'Drop-In Day' (Sydney) for SMEs

The Therapeutic Goods Administration is seeking expressions of interest for a potential Drop-In Day: an opportunity to meet with TGA representatives one-on-one to discuss the regulatory process with respect to your products and business. Drop-In Day is tentatively open to small-to-medium enterprises (SMEs), researchers and start-ups that are new to therapeutic goods regulation, don't often engage with the TGA, are looking to supply a therapeutic good in Australia for the first time and would like advice about preparing their application for market authorisation. It is important to note that advice will not be provided regarding existing applications or already approved products. Appointments will be 50 minutes in duration. There is no cost to attend. Proposed meetings are to be held on Thursday 11th April 2019 in Parramatta, NSW. Source: TGA drop-in day

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

Make Coarser Make Bigger capsules: the capsules contain the undeclared substances 2-mercaptobenzothiazole, diclofenac and glibenclamide.