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New Zealand’s outdated dietary supplement regulations extended but to be replaced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.