Latest Regulatory Affairs Newsletter

Consultant,

A collection of regulatory news from this month.

Permitted Indications - Reminder

The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice!

Update list of Ingredients permitted in Listed Medicines

An update to the list of permitted ingredients - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020) - was released on 16th December. A link to the updated list and a summary of changes can be found here.

Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices

The Therapeutic Goods Administration (TGA) has released a guidance document to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete. Source: Guidance for Declaration of Conformity

How to Respond to a Post Market Review for a Medical Device

This compliance dashboard gives very detailed guidance on how to review and reply to a TGA notification. Source: TGA

Listed medicines required to be tested for Aristolochic acids

For safety reasons Aristolochic acids and all plant species that might contain Aristolochic acids are prohibited from supply, sale or use in medicines in Australia. Some listed medicines are at risk of containing aristolochic acids due to inadvertent substitution. To address this risk, the Therapeutic Goods Administration (TGA) places a condition of listing which requires that sponsors of these medicines confirm the absence of aristolochic acids in their medicine and get TGA approval before releasing each batch of the medicine. If you are the sponsor of listed medicines which have the aristolochic acids condition of listing, you should review your records and ensure that you:

hold evidence to confirm the absence of aristolochic; and
provide this evidence to us at the TGA for evaluation and approval, prior to supply of each batch in Australia.

Source: Presence of aristlochic acids

Changes to requirements for listed medicines – Magnesium and Andrographis paniculata

The Therapeutic Goods Administration has published ‘Outcomes: Low-negligible risk changes to Permissible Ingredients - 2020-2021’. This impacts magnesium salts and Andrographis paniculate. The changes will commence on 1 March 2021. Source: Outcomes of Consultation.

Applications now open for the Manufacturing Modernisation Fund Round 2

The Modern Manufacturing Strategy is funding $1.5 billion for eligible manufacturers. Manufacturers can apply for co-funding under the initiative. To be eligible for grants businesses will need to demonstrate expected job growth and the upskilling of their existing employees. Applicants will also need to demonstrate alignment with the National Manufacturing Priorities. The Manufacturing Modernisation Fund is the first program to open under the Modern Manufacturing Strategy which will assist Australian manufacturers to scale-up, improve their competitiveness and to build resilient supply chains. Subscribe to updates at the Department of Industry, Science and Energy – here.

Therapeutic Goods Administration COVID-19 Proceedings

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). There is now a TGA page which lists all face masks that have been cancelled from the ARTG during the review. Source: Cancelled face masks

Man fined $10,656 for alleged unlawful advertising of cannabidiol including COVID-19 claims

Infringement notices totalling $10,656 have been issued to a West Australian man, for alleged unlawful advertising of cannabidiol (CBD). The man allegedly advertised, on websites and a social media platform, various oils containing CBD that were prescription only medicines. The Act prohibits consumer advertising of substances included in Schedule 4 (prescription only medicine) or Schedule 8 (controlled drug) of the Poisons Standard. The TGA alleges that the man referred to prohibited representations in promoting the CBD oils on a social media platform as a treatment for cancer and a cure for brain tumours. Source: TGA media release

GMP annual report

The TGA has released its annual GMP report for the financial year 2019-2020. This includes information on the number of different types of GMP licensing applications received and inspections carried out, processing times for both local and overseas manufacturers, and outcomes of the inspections. On page 13 there is a list of common deficiencies. Interestingly, 29 local manufacturers were given an A1 compliance rating based on inspections conducted during the 2019¬20 financial year. Source: TGA news release

Laboratory Testing Results

The TGA has posted their database of laboratory testing results. Although numerous products passed the tests applied, many did not, and results included bacterial contamination, presence of prohibited substances such as Aristolochic Acid and Amygdalin. Source: TGA.

Country of Origin

On 10th December the country of origin regulations were updated, providing clarity to manufacturers of complementary medicines as to what is a “process of substantial transformation”. The updated legislation can be viewed here.

ACCC Proceedings

Alkaloids of Australia Pty Ltd and its former export manager, Christopher Kenneth Joyce, have each been charged with 33 criminal cartel offences, contrary to the Competition and Consumer Act 2010, formerly the Trade Practices Act 1974, following a criminal investigation by the ACCC. The ACCC alleges that Alkaloids of Australia and other overseas suppliers of SNBB made and gave effect to arrangements to fix prices, restrict supply, allocate customers and/or geographical markets, and/or to rig bids for the supply of SNBB to international manufacturers of generic antispasmodic medications. Alkaloids of Australia produces and supplies the active pharmaceutical ingredient SNBB (scopolamine N-butylbromide, also known as hyoscine butylbromide), which is the active pharmaceutical ingredient in antispasmodic medications taken to relieve stomach pain and bowel cramps. Source: ACCC media release

Unlawful Importation of Cosmetic Injectables

The Magistrates Court of Victoria has convicted a Melbourne woman on three charges of unlawful importation of therapeutic goods, namely dermal filler medical devices (pre-filled syringes containing hyaluronic acid) and hyaluronidase (enzymes that can be used to dissolve dermal fillers), which is a therapeutic good for cosmetic use in humans. At the time of importation, the woman had not included the goods in the Australian Register of Therapeutic Goods (ARTG). Fines were issued but were unpaid. Criminal prosecutions are an enforcement tool the TGA can use to address serious non-compliance and in cases where infringement notices have not been paid. Source: TGA

Down-schedule of low dose cannabidiol (CBD) preparations

The Therapeutic Goods Administration (TGA) has down-scheduled certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine). Low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription. The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures. Source: TGA media release

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AICIS Release Guidance and Documents

The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients. Annual declaration and post-introduction declaration forms will be available at the end of November.

AICIS has recently published guidance on the following topics:

Guide to applying online for an assessment certificate
Categorisation of chemicals introduced for research and development
Extra guidance on categorising polymers
FAQs on Low-risk flavour or fragrance blend introductions
Guide to categorising internationally assessed introductions. Source: AICIS

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Permitted Indications - Reminder

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

See story under Foods heading below

Therapeutic Goods Administration Product Recall

Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445) are not suitable for consumers with a milk allergy as it contains milk products and have been recalled. Source: Safety advisory - Contains undeclared milk products

Adulteration Schemes

Written by members of the American Botanical Council Botanical Adulterants Prevention Program (BAPP)this article details some of the adulteration practices that appear to be attempts at surpassing commonly used analytical techniques for herbs and botanicals. Ingredients for which adulteration has been reported include, extracts of bilberry (Vaccinium myrtillus) fruit, black cohosh (Actaea racemosa) root/rhizome, cranberry (Vaccinium macrocarpon) fruit, ginkgo (Ginkgo biloba) leaf extract, saw palmetto (Serenoa repens) fruit, and St. John's wort (Hypericum perforatum) herb, among others. COVID-19 is only further exacerbating the adulteration problem, the BAPP warns, with sharp increases in demand and supply shortages of certain botanical ingredients causing companies to seek out new suppliers. Source: Adulteration schemes

Adulteration of Milk Thistle (Silybum marianum)

A bulletin from the American Botanical Council identifies issues of adulteration of milk thistle (Silybum marianum, Asteraceae) fruit and its extracts. In an estimated 30–50% of milk thistle products, the label claims of active ingredients do not hold up in the actual product, when analysed with methods such as HPLC-UV. Source: Adulteration of Milk thistle

Pharmacovigilance

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now closed. This program is designed to facilitate the collection and evaluation of safety information relating to all medicines on the ARTG. It involves TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements. To read more about your obligations refer to the TGA responsibilities document.and inspection program guidance.

Notification of a New Proprietary Ingredient

There is a revised form and guidance on the TGA website for a proprietary ingredient notification. This is for suppliers of ingredient mixtures, such as flavours or fragrances, who do not wish to disclose the mixture's formulation details (such as ingredient quantities) to sponsors of the therapeutic goods on the Australian Register of Therapeutic Goods (ARTG). Source: Proprietary ingredient Post

Therapeutic Goods Administration Face Mask Review

The TGA is undertaking a post-market review of all face masks included in the ARTG. Concerns have been raised about the quality and effectiveness of some face masks, including that they are on the ARTG but do not meet the legislative requirements for medical devices, or do not, perform as intended. Source: Post Market Review

Therapeutic Goods Administration Product Defect Alert

The TGA has issued a Product Defect Alert notice for Softmed branded surgical masks manufactured by Wuhan Topmed following a post market review. These face masks have been supplied under the Australian Register of Therapeutic Goods (ARTG) entry 333133 by the sponsor M House. TGA testing showed the masks did not perform, in relation to fluid resistance claims, as labelled. When tested by the TGA Laboratories, some batches of the masks did not perform at Level 3 but passed at Level 2. Others did not perform at Levels 2 and 3 but passed at Level 1. The TGA is awaiting further information from the sponsor regarding some of the Softmed masks and will consider if further regulatory action will be required. The masks have not been imported into Australia by the sponsor since July 2020, and there are no plans to supply them in the foreseeable future. Source: Product defect alert for some Softmed branded surgical masks

Therapeutic Goods Administration COVID-19 Proceedings

The TGA has issued an infringement notice for $13,320 to Target Australia Pty Ltd for the alleged importation of surgical face masks not on the Australian Register of Therapeutic Goods (ARTG). Source: TGA Notice

Victoria-based company Manningham Corporation Pty Ltd was fined $13,320 Source: TGA Notice and a woman based in Victoria fined $2,664 for the alleged unlawful importation of medical face masks in relation to COVID-19 Source: TGA Notice. Nafara Australia has been fined $13,320 for unlawful supply of face masks Source: TGA Notice.

Therapeutic Goods Administration Proceedings

In other TGA actions, Australian Beauty Group Pty Ltd has been fined $26,640 for alleged advertising breaches in which they advertised on their websites non-contact thermometers and implied the TGA had endorsed the medical devices. Promoting products as "TGA approved" or "TGA registered", or including other government endorsements, whether they are included in the Australian Register of Therapeutic Goods (ARTG) or not, is a breach of the Therapeutic Goods Act 1989 (the Act). Source: TGA Notice

Alleged Unlawful Advertising of Hydrogen Peroxide

Analytical Products & Services Pty Ltd (ANPROS) has received three infringement notices totalling $39,960 for advertising hydrogen peroxide as a treatment for cancer and emphysema Source: TGA Notice. a Sydney man has been fined $10,656 for unlawful advertising of hydrogen peroxide and Condy’s crystals for treatment of coronavirus and cancer. Source: TGA Notice

Unlawful Advertising of a Complementary Medicine

Cat Media has been fined $13,320 for advertising a product called Fat Baster Apple Cider Vinegar and Garcina Max that was not included in the Australian Register of Therapeutic Goods (ARTG). Source: TGA Notice

TGA Provides Latest Guidance on Advertising Requirements

The TGA has published guidance on how advertisers can lawfully advise consumers that a product is included in the ARTG. Source: TGA Advertising therapeutic goods

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TGA Manufacturing Webinar

A webinar the TGA presented at RACI NSW Pharmaceutical Science Group is now available on the TGA website. The topic is “Remote Inspections from TGA perspective - Impact of Covid-19 Restrictions on Manufacturers and Test Laboratories”. Source: TGA Webinar

Remote Inspections of Overseas Manufacturers

The TGA has published guidance for overseas manufactures on how they conduct remote GMP inspections here and here.

Government Program to Support Manufacturing

A $1.5 billion investment in a Modern Manufacturing Strategy has been announced with funding for eligible manufacturers for key manufacturing initiatives. Manufacturers can apply for co-funding under the Modern Manufacturing initiative. To be eligible for grants businesses will need to demonstrate expected job growth and the upskilling of their existing employees. Applicants will also need to demonstrate alignment with the National Manufacturing Priorities. Subscribe to updates at the Department of Industry, Science and Energy – here.

Failing Food Reports – September 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of September. Among the usual pathogens detected in these imported foods are such organisms as E.coli (found in Indonesian and Vietnamese clam) and assorted toxins such as histamine (found in anchovies from the Philippines), and the illegal addition of vitamins to many foods (Vitamin B5 in shakes from the Netherlands). Numerous foods seized due to excessive amounts of caffeine. Source: Food fails September 2020

FSANZ Notifications

Application A1214 – Nicotinamide riboside chloride as Vitamin BS in FSMP: Application to amend the Food Standards Code to permit the use of nicotinamide riboside chloride as a permitted form of Vitamin B3 in food for special medical purposes (FSMPs). Source: Application A1214

Application A1215 – Cetylpyridinium chloride as washing processing aid: To request the addition of Cetylpyridinium chloride (CPC) to Schedule 18 of the Australia New Zealand Food Standards Code. Source: Application A1215

Application A1193 – Application to approve the use of irradiation as a phytosanitary measure for all types of fresh fruits and vegetables. Source: Application A1193

Proposal P1051 – Code Revision (2020) - The purpose of this proposal is to make minor amendments to the Food Standards Code, including the correction of typographical errors, formatting issues and updating of references. Source: Proposal P1051

Public Consultation

The consultation ‘Public Consultation – Consistency of food regulatory approaches’ is available through the Department of Health’s Consultation Hub. Survey responses and submissions are due by midnight 18 December 2020. This is part of the plan to reform the Bi-national Food Regulation System and includes a comprehensive review of the Food Standards Australia New Zealand Act 1991 and the Intergovernmental Food Regulation Agreement. Source: Modernisation of the food regulation system

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released. Source: Federal Register of Legislation. From 30 November certain sports supplements are regulated as therapeutic goods (medicines). Department of Agriculture, Water and the Environment imported food notice to advise of requirements released here.

Konjac Restrictions

The Department of Agriculture, Water and the Environment released a reminder imported food notice to advise that mini jelly cups containing konjac having a height or width of less than or equal to 45mm are banned for sale under the Australian Consumer Law within the Competition and Consumer Act 2010. Source: Konjac imported food notice

Product Recall

Pete Evans Healthy Everyday Jamaican Simmer Sauce 330g has been recalled, as Thai Green Curry Sauce 330g has been labelled incorrectly as Jamaican Simmer Sauce 330g which has resulted in the presence of fish (an undeclared allergen). Source: Food Recall

Made in Australia

Simplot Australia has amended the country of origin labelling on 31 frozen fish products, from ‘Made in Australia’ to ‘Packed in Australia’, following concerns raised by the ACCC. The fish were imported and not substantially transformed in Australia. Source: ACCC news

Ingredients added to the Inventory

The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients.

Seven new industrial chemicals have been added to the Australian Inventory of Industrial Chemicals in accordance with section 83 of the Industrial Chemicals Act 2019 this month. Source: Chemicals added

Accord's 'Hand Sanitiser Industry Benchmark for non-therapeutic products'

Accord has published a “Hand Sanitiser Industry Benchmark for non-therapeutic products” providing requirements for the quality of hand sanitiser ingredients, guidance on product performance (efficacy), safety, record keeping and quality assurance considerations, and guidance on packaging type, product claims and labelling. Source: Industry benchmark

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