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.