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

 

Medical cannabis

Summary of a recent online presentation on medicinal cannabis advertising compliance has been published. TGA presented along with professional experts. Find it here.

RFA Breaking News

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Foods:

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Complementary Medicines and Medical Devices:

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New chemical report as at 15th April. This lists the new chemical public reports published for three new chemicals.    Source: AICIS.   Unregistered importer fined. The imported chemical is…

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Foods:

Review of the Australia New Zealand Food Standards Code The review commenced in July 2020. The plan is to reform the bi-national food regulation system to ensure it remains strong,…

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Complementary Medicines and Medical Devices:

TGA conducting forum on GMP This will be a virtual event, to be held from Wednesday 12th to Friday 14th May, free of charge for members of the industry. More…

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