Permitted Indications - Reminder

The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice if you are uncertain of your obligations.

 

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

See story under Foods heading below

 

Therapeutic Goods Administration Product Recall

Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445) are not suitable for consumers with a milk allergy as it contains milk products and have been recalled.    Source: Safety advisory - Contains undeclared milk products

Adulteration Schemes

Written by members of the American Botanical Council Botanical Adulterants Prevention Program (BAPP)this article details some of the adulteration practices that appear to be attempts at surpassing commonly used analytical techniques for herbs and botanicals. Ingredients for which adulteration has been reported include, extracts of bilberry (Vaccinium myrtillus) fruit, black cohosh (Actaea racemosa) root/rhizome, cranberry (Vaccinium macrocarpon) fruit, ginkgo (Ginkgo biloba) leaf extract, saw palmetto (Serenoa repens) fruit, and St. John's wort (Hypericum perforatum) herb, among others. COVID-19 is only further exacerbating the adulteration problem, the BAPP warns, with sharp increases in demand and supply shortages of certain botanical ingredients causing companies to seek out new suppliers.    Source: Adulteration schemes

 

Adulteration of Milk Thistle (Silybum marianum)

A bulletin from the American Botanical Council identifies issues of adulteration of milk thistle (Silybum marianum, Asteraceae) fruit and its extracts. In an estimated 30–50% of milk thistle products, the label claims of active ingredients do not hold up in the actual product, when analysed with methods such as HPLC-UV.    Source: Adulteration of Milk thistle

 

Pharmacovigilance

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now closed. This program is designed to facilitate the collection and evaluation of safety information relating to all medicines on the ARTG. It involves TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements. To read more about your obligations refer to the TGA responsibilities document.and inspection program guidance.

Notification of a New Proprietary Ingredient

There is a revised form and guidance on the TGA website for a proprietary ingredient notification. This is for suppliers of ingredient mixtures, such as flavours or fragrances, who do not wish to disclose the mixture's formulation details (such as ingredient quantities) to sponsors of the therapeutic goods on the Australian Register of Therapeutic Goods (ARTG).    Source: Proprietary ingredient Post

 

Therapeutic Goods Administration Face Mask Review

The TGA is undertaking a post-market review of all face masks included in the ARTG. Concerns have been raised about the quality and effectiveness of some face masks, including that they are on the ARTG but do not meet the legislative requirements for medical devices, or do not, perform as intended.    Source: Post Market Review

 

Therapeutic Goods Administration Product Defect Alert

The TGA has issued a Product Defect Alert notice for Softmed branded surgical masks manufactured by Wuhan Topmed following a post market review. These face masks have been supplied under the Australian Register of Therapeutic Goods (ARTG) entry 333133 by the sponsor M House. TGA testing showed the masks did not perform, in relation to fluid resistance claims, as labelled. When tested by the TGA Laboratories, some batches of the masks did not perform at Level 3 but passed at Level 2. Others did not perform at Levels 2 and 3 but passed at Level 1. The TGA is awaiting further information from the sponsor regarding some of the Softmed masks and will consider if further regulatory action will be required. The masks have not been imported into Australia by the sponsor since July 2020, and there are no plans to supply them in the foreseeable future.    Source: Product defect alert for some Softmed branded surgical masks

 

Therapeutic Goods Administration COVID-19 Proceedings

The TGA has issued an infringement notice for $13,320 to Target Australia Pty Ltd for the alleged importation of surgical face masks not on the Australian Register of Therapeutic Goods (ARTG). Source: TGA Notice  

Victoria-based company Manningham Corporation Pty Ltd was fined $13,320    Source: TGA Notice and a woman based in Victoria fined $2,664 for the alleged unlawful importation of medical face masks in relation to COVID-19    SourceTGA Notice. Nafara Australia has been fined $13,320 for unlawful supply of face masks   Source: TGA Notice.

 

Therapeutic Goods Administration Proceedings

In other TGA actions, Australian Beauty Group Pty Ltd has been fined $26,640 for alleged advertising breaches in which they advertised on their websites non-contact thermometers and implied the TGA had endorsed the medical devices. Promoting products as "TGA approved" or "TGA registered", or including other government endorsements, whether they are included in the Australian Register of Therapeutic Goods (ARTG) or not, is a breach of the Therapeutic Goods Act 1989 (the Act).    Source: TGA Notice

 

Alleged Unlawful Advertising of Hydrogen Peroxide

Analytical Products & Services Pty Ltd (ANPROS) has received three infringement notices totalling $39,960 for advertising hydrogen peroxide as a treatment for cancer and emphysema Source: TGA Notice.  a Sydney man has been fined $10,656 for unlawful advertising of hydrogen peroxide and Condy’s crystals for treatment of coronavirus and cancer.    Source: TGA Notice

 

Unlawful Advertising of a Complementary Medicine

Cat Media has been fined $13,320 for advertising a product called Fat Baster Apple Cider Vinegar and Garcina Max that was not included in the Australian Register of Therapeutic Goods (ARTG).    Source: TGA Notice

 

TGA Provides Latest Guidance on Advertising Requirements

The TGA has published guidance on how advertisers can lawfully advise consumers that a product is included in the ARTG.    Source: TGA Advertising therapeutic goods

 

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

 

TGA Manufacturing Webinar  

A webinar the TGA presented at RACI NSW Pharmaceutical Science Group is now available on the TGA website. The topic is “Remote Inspections from TGA perspective - Impact of Covid-19 Restrictions on Manufacturers and Test Laboratories”.    Source: TGA Webinar 

 

Remote Inspections of Overseas Manufacturers

The TGA has published guidance for overseas manufactures on how they conduct remote GMP inspections here and here.

 

Government Program to Support Manufacturing

A $1.5 billion investment in a Modern Manufacturing Strategy has been announced with funding for eligible manufacturers for key manufacturing initiatives. Manufacturers can apply for co-funding under the Modern Manufacturing initiative. To be eligible for grants businesses will need to demonstrate expected job growth and the upskilling of their existing employees. Applicants will also need to demonstrate alignment with the National Manufacturing Priorities. Subscribe to updates at the Department of Industry, Science and Energy – here.

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