Complementary Medicines and Medical Devices:

Permitted Indications – Reminder – not much time left!

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 by the TGA. 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. Ask us for advice!

Update list of indications for use permitted in Listed Medicines

An update to the list of permitted indications - Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 - was released on 21st January. A link to the updated list and a summary of changes can be found on TGA website.

ACCC takes Lorna Jane to court over 'Anti-virus Activewear' claims

ACCC has launched legal proceedings against Lorna Jane Pty Ltd due its publication on social media platforms, in its stores and on its website “Cure for the Spread of COVID-19? Lorna Jane Thinks So”, “With Lorna Jane Shield on our garments it meant that we were completely eliminating the possibility of spreading any deadly viruses”, and “LJ Shield – Protecting you with ANTI-VIRUS ACTIVEWEAR”.   Source: ACCC

Post-market review of face masks

TGA has summarised the results of its post-market review of face masks including a list of face masks that have been cancelled.   Source: TGA

Life Biotech Pty Ltd fined $106,560 for alleged non-compliance with requests for information and face mask samples in relation to COVID-19

The TGA has been conducting a post-market review of face masks. The TGA alleges that Life Biotech failed to provide samples to the TAG, failed to provide information and also provided partial, late and misleading responses to other requests.    Source: TGA

Safety advisory – medicines containing Eucommia ulmoides

Medicines containing Eucommia ulmoides - (known as Du-Zhong or Tu-chung), may pose a risk for individuals with a latex allergy or sensitivity.    Source: TGA

Product recall – Infants’ Friend

Due to the presence of a small amount of chloroform, there was a potential for children to consume an unacceptably high level of chloroform.   Source: TGA

Quality and safety of medicinal cannabis products

The TGA is consulting on introducing GMP requirements for products manufactured overseas so they are equivalent to those manufactured domestically.   Source: TGA

Test methods for cannabinoids

This method describes the analysis of samples derived from Cannabis species, specifically the assay of the primary compounds of regulatory interest [Tetrahydrocannabinolic Acid (THCA), Tetrahydrocannabinol (THC), Cannabidiolic Acid (CBDA) and Cannabidiol (CBD)] by UPLC coupled with UV or PDA.    Source: TGA

Nicotine e-cigarettes now only available by prescription only

This aims to prevent adolescents and young adults from taking-up nicotine e-cigarettes while allowing current smokers to access these products for smoking cessation on their doctor's advice. The products will be available from a pharmacy on presentation of a medical doctor’s prescription.   Source: TGA

Amendments to the SUSMP (“the Poisons Standard”)

Has just been released. The change to scheduling of boric acid will be of interest to suppliers of complementary medicines, cosmetics and oral hygiene products.   Source: TGA

Pharmacovigilance obligations of medicine sponsors

Sponsors of medicines (including complementary medicines) have an obligation to collect and report adverse events. A “Frequently asked questions” page has been published on the TGA website here.

Foods:

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

New applications:

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

Cosmetics, Personal Care and TGA Listed Sunscreens:

Chemicals added to the Inventory following issue of assessment certificate - 27 January 2021

Variation of Inventory listing following revocation of CBI approval - 25 January 2021

Chemicals added to the Inventory 5 years after issue of assessment certificate - 25 January 2021

*** Learn more about AICIS and cosmetic regulatory changes***

We offer a 1 hour zoom training course on the new AICIS regulatory requirements for cosmetics and ingredient assessments. Contact us for more information by emailing This email address is being protected from spambots. You need JavaScript enabled to view it.