Complementary Medicines and Medical Devices:

Pharmacovigilance – important reading for all suppliers/sponsors and manufacturers of complementary medicines! This is an often overlooked responsibility and the TGA is now issuing fines for non-compliance - see next story. RFA offers a 1.5 hour course (much cheaper than getting a fine!) which includes a full set of documents and procedures. Courses are conducted by via Zoom, by appointment. This email address is being protected from spambots. You need JavaScript enabled to view it. for details or go here: https://rfaregulatoryaffairs.com/training-courses .

Information also publicly available on CMA website.

 

Compliance enforcement

Ferngrove Pharmaceuticals fined $13,320 for alleged breaches of legislation in relation to pharmacovigilance - failure to provide information on a contact person responsible for medicine safety.    TGA

Kardwi Pharmaceuticals fined $13,320 for alleged breaches of legislation in relation to pharmacovigilance - failure to provide information on a contact person responsible for medicine safety.    TGA

Shen Neng Herbal Medicines Group fined $53,280 for alleged breaches of legislation - breaching a condition of listing and failing to provide information to the TGA. The same company was fined $100,800 in 2020 in relation to breaches of supply, labelling and pharmacovigilance.    Source: TGA

Dentist fined $5,328 for alleged unlawful importation of Botox.    TGA

CheckMe fined $13,320 for alleged unlawful import of rapid antigen test kits.    TGA

G1 Resources fined $26,640 for alleged importation and advertising of unapproved rapid antigen tests.    TGA

Cat Media fined $39,960 for advertising unregistered weight-loss products. This is the third time that the TGA has issued such notices to Cat Media.    TGA

24K Rhino capsules – tested and found to contain undeclared sildenafil.    Source: TGA

 

Advertising Code. A very useful FAQ page, a “must” read. Explains some important issues especially testimonials and endorsements. This explains the TGA decisions. Other topics include mandatory statements, health warnings, short form advertisements, restricted representations and social media advertising.    Source: TGA

 

Transitioning to the new Therapeutic Goods Advertising Code. Mandatory statement requirements in the 2021 Code have been simplified and reduced in number.    Source: TGA

 

Training course in advertising: RFA offers a one hour training course on advertising. Information here: https://rfaregulatoryaffairs.com/training-courses

 

Reporting medicine adverse events – a presentation delivered by the TGA on 30th March.    Source: TGA

 

Urgent national product recall. iNova Pharmaceuticals has recalled a batch of Kynd Stress Relief tablets containing the equivalent of 6 g of Withania somnifera (Ashwagandha) per tablet, due to an unexpected number of allergic reactions.    Source: TGA

 

Ingredients permitted in listed medicines. Updated in April 2022, a list of the 2 added ingredients and 5 changed ingredients.    Source: TGA

 

Bacillus coagulans Strain MTCC 5856 a compositional guideline has been published.    Source: TGA

 

Good Manufacturing Practice – summary of TGA-Industry Working Group meeting on 25th February.    Source: TGA

 

TGA performance review. This covers the period 1st July to 31st December 2021, and includes processing and approval times. During this time there were 1,055 new listed medicine applications.    Source: TGA

 

Updates to standard for medicinal cannabis. Includes 2022 updates. This is for manufacturers and sponsors, to assist in ensuring medicinal cannabis products conform with Therapeutic Goods Order 93.    Source: TGA

 

Webinar: Medicinal cannabis reforms. Contents of a webinar delivered by the TGA explaining the changes to TGO 93.    Source: TGA

 

Approved COVID-19 rapid antigen self-tests. This list is regularly updates by the TGA.    Source: TGA

 

Medical devices reforms. Consumer Working Group of costumer and patient representatives meets regularly.  A small working group of volunteers formed the Medical Devices Action Plan Consumer Working Group.    Source: TGA

 

Therapeutic Goods Advertising Consultative Committee. Last met on 21st March. Among other issues, the Committee discussed the issue of the supply of therapeutic goods that are not included on the Australian Register of Therapeutic Goods (ARTG) and considered whether allowing references to the TGA in advertising would enable consumers to more easily distinguish therapeutic goods that are on the ARTG.    Source: TGA

 

 

Foods:

Imported kava – update to the definition of permitted kava products and labelling requirements for retail ready packs and bulk imported kava not for immediate retail sale.    Source: Dept Agriculture, water and Environment

 

Failing imported food reports for January 2020

List of – 22 products that failed testing.    Source: Dept Agriculture, water and Environment

 

Call for submissions and comments

Proposal – P1028 Infant Formula: To revise and clarify standards relating to infant formula products comprising category definitions, composition, labelling and representation of products. Deadline 10th June.    Source: FSANZ

M1019 - Review of Schedule 22 – Foods and classes of foods.    Source: FSANZ

A1244 - Chymosin from GM Trichoderma reesei as a processing aid (enzyme).    Source: FSANZ

 

Plasticisers in Australian Foods. A survey of the levels of seven plasticisers which may be used in food packaging materials found the levels were generally low. Estimated dietary exposure for Australian consumers was below internationally recognised safe levels.    Source: FSANZ

 

Food Recalls

Kahlua Espresso Martini – alcohol content mislabelled.    Source: NSW Food Authority

Coles Baby Spinach - potential microbial (Salmonella) contamination.    Source: NSW Food Authority

Coles Organic Unsweetened Coconut Milk - undeclared allergen - milk. The label also incorrectly advises the product is suitable for vegans.    Source: NSW Food Authority

Various Ferrero Kinder chocolate products - potential microbial (Salmonella) contamination.    Source: NSW Food Authority

Malt Brewing Co PTY LTD (Revel Brewing Co) Pine Lime Sour Ale - potential secondary fermentation.    Source: NSW Food Authority

Trans Oriental Import and Export Garden Fortune Cookies - chemical (naphthalene) contamination.   Source: FSANZ

Macro Certified Organic plant-based milks - presence of an undeclared allergen (milk).    Source: NSW Good Authority

Barossa Fresh Lamb Mince and Beef Mince - presence of foreign matter (plastic, metal).    Source: FSANZ

Vegan Perfection Golden Crunch Vegan Honeycomb - presence of an undeclared allergen (milk) (milk is not vegan!).    Source: NSW Food Authority

Terra Madre Organic Vegan Chocolate Coated Almonds - undeclared allergens (tree nuts [cashew and hazelnut].    Source: FSANZ

 

Call for submissions and comments

Proposal – P1028 Infant Formula: To revise and clarify standards relating to infant formula products comprising category definitions, composition, labelling and representation of products. Deadline 10th June.    Source: FSANZ

M1019 - Review of Schedule 22 – Foods and classes of foods.    Source: FSANZ

A1244 - Chymosin from GM Trichoderma reesei as a processing aid (enzyme).    Source: FSANZ

 

 

Cosmetic, Personal Care and TGA Listed Sunscreens:

Guide to categorising your chemical importation and manufacture. Updates to the guide.    Source: AICIS

 

Draft evaluation of a chemical with CAS number 1428963-39-6. Call for comment, deadline 3rd June.    Source: AICIS

 

Guidance to help foreign companies interested in selling their chemicals and products in Australia and assist businesses that supply information in AICIS applications or declarations – but don’t wish to disclose their trade secrets.   Source: AICIS

 

Chemicals added to the Inventory 5 years after issue of assessment certificate. Updated 5th April.    Source: AICIS

 

Product safety rules and standards

Discover which products are banned. Check if your product has mandatory standards. Find out what standards you need to comply with. Learn what you need to do to comply with the Australian Consumer Law, including product safety. Includes product safety rules in the various state and territories.    Source: Australian Government Business

 

Biodegradable, degradable and recyclable claims on plastic bags. A very useful guidance document.    Source: ACCC

 

New Zealand

Proposed changes to recycling laws. The New Zealand Government is seeking feedback on three proposals the guidance to make it faster and easier for business elating to transforming recycling: 1. Container Return Scheme 2. Improvements to household kerbside recycling 3. Separation of business food waste.    Source: Cosmetics New Zealand.

 

Industry support for ending animal testing for cosmetics. New Zealand has not tested on animals for cosmetics for over 30 years and in 2015, NZ made it illegal to test cosmetics products or ingredients on animals.    Source: Cosmetics New Zealand and New Zealand Ministry for the Environment

 

New recall guidance. New Zealand Food Safety has updated the guidance to make it faster and easier for all food businesses.    Source: Ministry for Primary Industries

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