Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines and Medical Devices:
Artemisia annua and Artemisia absinthium updated product recalls
A further 8 products have been cancelled and recalled. It seems there is an unacceptable risk if these products are used during pregnancy, and the cancelled products did not include the mandatory label warning statement about pregnancy. Source: TGA News
Updated guide to medicine labelling requirements
This is an updated guide to the two labelling orders Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) (including complementary medicines). Source: TGA guidance document
Industry Forum on Good Manufacturing Practice (GMP)
TGA has announced the third GMP forum, which will be held over three half days on Wednesday, 12 May - Friday, 14 May 2021. This will be a virtual event and it will be free to attend. TGA states “This Forum will be of interest to industry personnel involved in the quality assurance, regulation, risk assessment and good manufacturing practice of medicines and biological products.” Source: TGA news
Changes to ingredients permitted in listed medicines
This is a summary of the changes to 169 ingredients. Source: TGA news
TGA compliance activity
CW IP Pty Ltd fined $53,280 for alleged advertising breaches on the Chemist Warehouse and My Chemist websites. They allegedly advertised Fatblaster Clinical capsules, a therapeutic good, on four pages of its Chemist Warehouse and My Chemist websites. At the time of advertising, Fatblaster Clinical capsules were not entered in the Australian Register of Therapeutic Goods. The TGA cancelled Fatblaster Clinical capsules from the ARTG on 20 December 2019. Source: TGA news
Newcastle-based retailer Junction Rx trading as My Community Pharmacy (Junction Rx) has been issued an infringement notice for $13,320 for alleged advertising of an unlisted complementary medicine after they failed to comply with a cease and desist notice by the set deadline. They advertised a therapeutic good called ‘FatBlaster Apple Cider Vinegar and Garcinia Max' which is not included on the Australian Register of Therapeutic Goods. Source: TGA news
Epharmacy Group fined $26,640 for alleged unlawful advertising on the ePharmacy website. The fines were issued for the alleged unlawful advertising of Fatblaster Clinical, a complementary medicine cancelled from the Australian Register of Therapeutic Goods. Source: TGA News
Bulk Buys fined $13,320 for alleged unlawful importation of surgical face masks. TGA claims they breached a condition of the Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 by importing surgical face masks that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile. Source: TGA news
Medicine packaging definitions
A useful guide to understanding packaging terms which do not always align between different regulations. What is the difference between “primary packaging” and “primary pack”? What is “tertiary packaging”? Source: TGA
New standard for serialisation and data matrix codes on medicines
1st January 2023 is the commencement date for the new Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021. This order does not make the use of data matrix codes or serialisation of medicines mandatory, but sets out requirements if medicine sponsors choose to do either of these. Medicines must comply with TGO 106 by 1st January 2023 if they are serialised, or include a dot matrix code that encodes the Global Trade Item Number (GTIN). Sources: TGA news, and Federal Register of Legislation
Medical devices – essential principles checklist
Available in either word or pdf format – this 28 page checklist will be very helpful for sponsors of medical devices. It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices. Source: TGA news
Standard for unapproved vaporiser nicotine products
TGA is proposing a standard and proposed safety and quality requirements. This is a copy of an online presentation. Source: TGA news
Post-market review of face masks
The TGA is continuing its review of face masks and this page summarises the findings. The TGA states some … “are not performing as intended, i.e. as claimed by the manufacturer. Some masks may pose a risk to public health and safety when used in healthcare settings or industrial / commercial settings where protection from contaminated fluids and airborne particulates is required”. Some products require no action, some have been cancelled, others need corrective action. Source: TGA face mask review
Summary of a recent online presentation on medicinal cannabis advertising compliance has been published. TGA presented along with professional experts. Find it here.
Cosmetics and TGA Listed Sunscreens:
Kimberley-Clark fined $200,000 for misleading country of origin statement
The website claimed the products were made in Australia. Source: ACCC
Correction of chemical names – updated to terminology. Source: AICIS
New Industrial chemicals – guide to preparing report
Guide to completing the most common type of pre-introduction report (PIR) – ‘highest indicative risk is low risk’. Source: AICIS
Complementary Medicines and Medical Devices:
Permitted Indications – Reminder – one week left! – If you don’t act NOW your products will be cancelled!
The deadline for all listed medicines to transition to only including permitted indications for their products is 5th March 2021. Any products that are non-compliant after this period will be cancelled. The very minimum you need to do is access your TGA product record, delete any free text indications, and ensure the only ones remaining are those on the list of permitted indications. Don’t forget - it is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use.
A new list of ingredients permitted in listed medicines has just been released. Source: Federal Register of Legislation.
AUST L(A) complementary medicines (Assessed listed medicines)
Parliament has passed a bill to provide clinical data protection for a period of 5 years.
Artemisia annua and Artemisia absinthium product recalls
TGA has announced that four products have been recalled due to the presence of high levels of artemisinin in Artemisia annua and Artemisia absinthium. The concern is an unacceptable risk if used during pregnancy. Source: TGA news
Illegal adulterated herbal products continue to be a problem
Products are regularly seized at the border, the latest is Resurrection Male Sexual Enhancement Capsules. Source: TGA news
New Zealand’s outdated dietary supplement regulations extended but to be replaced
A bill has passed through New Zealand parliament to allow an extension of the old Dietary Supplement Regulations, but there is widespread support for the development of more modern and relevant legislation to replace it. Source: Nutra Ingredients
The February 2021 update includes changes to boron and cannabidiol. Interim decisions are published for amygdalin and hydrocyanic acid, bilastine, psilocybin, magnesiun hydroxide, and other compounds.
Ex federal government senator directed to remove claims about COVID
David Leyonhjelm was advertising products containing ivermectin as a treatment for COVID. Source: TGA news.
Bajaria Global fined $26,640 for alleged unlawful importation of therapeutic goods containing betel nut
The products “Pan Masala” contained betel nut (the seed of the Areca palm Areca catechu) which is a prescription only medicine. The products were not included on the Australian Register of Therapeutic Goods (ARTG). TGA states “The Indian Journal of Medical and Paediatric Oncology published a review of the systemic adverse effects of betel nut. The journal article indicates betel nut is an addictive substance associated with a range of harmful health effects, including mouth and throat cancer. Consuming betel nut while pregnant may also be harmful to the unborn baby.” Source: TGA news
Haimex International fined $53,280 for alleged unlawful importation of medical devices
Products included infrared thermometers, rigid strapping tapes and iodine prep pads. None of the products were included on the ARTG. Source: TGA news
Federal court finds Evolution Supplements guilty of breaching advertising laws
We reported on the first story in our March 2020 newsletter. However, the director of Evolution Supplements, Mr Cumhur Keskin, failed to comply with previous directions about advertising of Selective Androgen Receptor Modulators (SARMs), and other products, when no SARM has been approved for human use. The use of SARMS has been linked to liver failure and increased risk of heart attack and stroke. Source: TGA news.
New Zealand guards against imported agricultural pests
New Zealand continues to be vigilant with imported foods that may damage their agricultural industry:
Bus driver fined NZ$4,500 for smuggling seeds and cigarettes
Auckland woman sentenced to intensive supervision for 12 months and 100 hours' community work for smuggling succulents and endangered cacti into New Zealand
And brown marmorated stink bugs continue to be a problem in both New Zealand and Australia. (Editor’s note: they are a pest on my two citrus shrubs and yes they do stink)
Maximum residue limits
Food Standards Australia New Zealand (FSANZ) today released its annual call for comment on proposed changes to Maximum Residue Limits (MRLs) for some agricultural and veterinary chemicals in food.
FSANZ Notifications and amendments
New applications: Application A1222 – Steviol glycosides from Yarrowia lipolytca:
Approval and notifications:
A1191 – Mono- and diglycerides of fatty acids (471) as a surface coating
A1202 – Food derived from insect-resistant and herbicide-tolerant corn line DP23211
Source: FSANZ media centre
Failing Food Reports November and December 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme. Once again, the usual pathogens were detected especially histamine, and the illegal addition of vitamins to foods including long grain rice from USA. Source: November and December.
Department of Agriculture announces changes to import conditions of some types of animal products
This notice mainly affects birds nests, table eggs, and goods that are imported in temperature-controlled containers below 10°C, that are imported for human consumption. These goods will undergo a more rigorous inspection. Source: Department of Agriculture, Water and the Environment
Department of Agriculture reviews biosecurity risks associated with importing dairy products
This review includes dairy products for human consumption manufactured from milk obtained from cattle, buffalo, sheep and goats. Source: Department of Agriculture, Water and the Environment
Pregnancy warnings on alcoholic beverages
Businesses have three years from 31 July 2020 to implement the requirements, FSANZ has published guidelines on design elements of the label and downloadable labels, and Q & A on Code requirements for pregnancy warning labels. Source: FSANZ
FSANZ Notifications and amendments
Call for comment on a new source for an enzyme processing aid - maltogenic alpha-amylase derived from Saccharomyces cerevisiae
Call for comment for food from genetically modified herbicide-tolerant canola
β-Galactosidase from Bacillus subtilis (Enzyme)
Alpha-amylase from GM Bacillus licheniformis as PA (Enzyme):
Beta-amylase from Bacillus licheniformis
Phospholipase A1 from Aspergillus niger
Source: FSANZ media centre
New Zealand Ministry of Primary Industry fines edible birds nest seller NZ$31,500
Birds nest are a potential source of avian pathogens. Source: NZ MPI