Pharmacovigilance Obligations - important reading, scroll down for full story
Changes to permitted ingredients list
This explains how often and why changes are made to the list. “High-moderate risk changes” have been made for Andrographis paniculata and caffeine. Source: TGA
Consultation on proposed improvements to the Therapeutic Goods Advertising Code
Unlawful advertising of a complementary medicine
Global Therapeutics has paid penalties of $119,880 in response to nine infringement notices issued by the TGA. The infringement notices related to five listed complementary medicines sponsored by Global Therapeutics. The advertising of these medicines was alleged to refer to serious conditions without approval or permission of the TGA, contravene requirements of the Therapeutic Goods Advertising Code, and include therapeutic uses that were not accepted as indications for the medicines. Source: TGA
Peter Evans Chef Pty Ltd fioned $79,920 for alleged unlawful advertising
Fines were issued to the company for the alleged advertising of therapeutic goods that were not, at the time of advertising, included in the Australian Register of Therapeutic Goods. These include the 'BioCharger' device, hyperbaric oxygen therapy chambers and two oral medicines. This is in addition to two fines issued in 2020. Source: TGA
Warning about unlawful advertising of listed medicines
This warning is particularly relevant to products that were cancelled in March 2021 for not transitioning to only include permitted indications. Source: TGA
ACCC issues five infringement notices to Mosaic Brands for alleged false or misleading representations
Mosiac Brands has paid penalties totalling $630,000 advertising breaches related to hand sanitisers and face masks:
- Air Clean hand sanitiser sold on the NoniB website contained 70 per cent alcohol, when a sample tested by the ACCC was found to contain 17 per cent alcohol;
- Miaoyue hand sanitiser sold by Millers contained 75 per cent alcohol, when a sample tested by the ACCC was found to contain 58 per cent alcohol;
- Velcare-branded hand sanitiser products sold on its websites were ‘WHO-approved’, when they were not;
- KN95 Kids Safety Face Masks sold on its websites were ‘CE/FDA certified’, when they were not; and
- KN 95 Adult Face Masks were” non-refundable”, when in fact consumers have a statutory right to a refund under the consumer guarantee remedies.
Proposed amendments to the poisons schedule
TGA warns about some counterfeit products being sold online, and summarises how to legally obtain medicinal cannabis. It is illegal to advertise medicinal cannabis. Source: TGA
Recall - Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets
Care Pharmaceuticals is recalling 10 batches of Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets due to the presence of Carthamus tinctorius flower (safflower flower) as an inactive ingredient. The level of exposure of Carthamus tinctorius flower in this product poses an unacceptable risk if used in pregnancy. Source: TGA
‘Meeting Your Obligations’ workshop
The TGA is live streaming another ‘Meeting Your Obligations’ workshop on Wednesday 23 June 2021. This is a free event aimed at beginners unfamiliar with therapeutic goods regulation. Registration page is here.
Medical device regulation reforms
Some medical devices are to be re-classified to align, wherever possible, with the changes being introduced in European Union medical devices framework. Comprehensive summary on TGA site.
Guidance on regulation of exempt disinfectants, and regulation of listed disinfectants
Listed disinfectants may make more specific claims, but listed disinfectants must still meet certain regulation requirements even though they are not required to be included on the Australian Register of Therapeutic Goods. TGA sources: listed disinfectants and exempt disinfectants.
Changes to regulation of nicotine e-cigarettes
From 1 October 2021 you will no longer be able to buy or import nicotine e-cigarettes or nicotine vaping products from overseas websites without a valid doctor's prescription. Child resistant closures for nicotine vaping products will also become mandatory to reduce the risk to children of accidental ingestion. Source: TGA
Large number of N95 face masks ailing tests.
According to the Sydney Morning Herald, one third of N95 face masks have failed testing. In the last 12 months, 48 defect alerts have been issued and 1,022 masks have had their registration cancelled. Source: smh.com.au and TGA
Faecal microbiota transplant products (“poo transplants”)
A faecal microbiota transplant product (a) comprises, contains or is derived from human stool; and (b) is for introduction into a person for a therapeutic use. Most are regulated as biologicals. What are they used for? Refer to TGA
Sponsors of all medicines including complementary medicines, are obliged to notify the TGA who they have nominated to be their pharmacovigilance contact person. Pharmacovigilance is the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems. As a sponsor of medicines you must:
- let the TGA know who your Australian pharmacovigilance contact person is
- have procedures in place to enable you to meet your pharmacovigilance obligations
- submit any serious adverse reaction reports to the TGA
- notify the TGA of any significant safety issues you identify
- keep records pertaining to the reporting requirements and safety for your medicine
- answer any request from the TGA for additional information within the specified timeframe.
Earlier this month the TGA announced it has issued an infringement notice for $13,320 to Arthropharm Pty Ltd for allegedly failing to provide information on a contact person responsible for medicine safety. Source: TGA