Listed and assessed listed medicines – a guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications – updated 21st July

Consultations:

* TGA is seeking comments on proposed changes to the Required Advisory Statements for Medicine Labels. RASML sets out advisory statements that are required to be included on the labels of specified OTC and registered complementary medicines. Closes 4th September, more information here.

* Comments requested on improvements to the Therapeutic Goods Advertising Code, to make sure it reflects current advertising practices, in particular should the TGA: – update the Code, or – provide clearer guidance to advertisers, and – understand the impact of proposed changes on stakeholders.. Closes 3rd  September, read more here.

* Proposed changes to the Permissible Indications Determination. This is the list of indications for use (“claims”) permitted for listed complementary medicines. The current list can be viewed here. Proposed amendments include: – Omission of the word mild from an indication referring to eczema – Inconsistent/incorrect requirements for indications relating to the thyroid – Lack of flexibility to use alternative label statements for an indication including the term antipyretic – Missing label statement requirement for an indication referring to neural tube defects – Missing label statement requirement for an indication referring to inducing sleep. A summary is here and a more detailed document is here. Closes 12th August.

* TGA is seeking comment on adoption of international scientific guidelines – in particular 11 guidelines which are listed here. Closes 11th September.

Advertising:

* Advertising health services and cosmetic injections. This is a VERY informative FAQ document published 21st July here.

* Advertising price lists for pharmacy and prescription-only medicines that are prohibited from advertising to consumers. A new guideline here.

* How to advertise therapeutic goods exclusively to health professionals. This guideline was updated 21st July.

* Applying the Advertising Code rules: price information. Explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public. Updated 21st July, here.

Applications to vary an entry in the Australian Register of Therapeutic Goods (ARTG) for a listed medicine if the entry contains information that is incomplete or incorrect – some applications will no longer be approved – details here. Information page is here.

How to access an unapproved therapeutic good – a guide for health practitioners: includes who can apply, what you can access and what to do before you apply. More here.

Updated guidelines

* Regulatory Guidelines for OTC Medicines updated 7th July, here.

* Regulatory Guidelines for Registered Complementary Medicines, updated 7th July is here

* How to determine whether your product is a cosmetic or therapeutic good – updated 3rd July, published here.

* How to change a listed or assessed listed medicine on the ARTG, includes changes that create a separate and distinct good. Published 16th July, source: TGA

* How to correct information in the ARTG about listed medicines, guideline updated 16th July, here

Dossier requirements for non-prescription medicines, including registered complementary medicines, assessed listed medicines and listed medicines, updated 7th July, here.

GMP clearance Sponsor Information Dashboard provides industry with regular updates about the backlog reduction, actual processing times, existing workloads, requesting prioritisation and other key messages for GMP clearance applications. Updated 27th July, here.

TGA licensed manufacturers – recent decisions include 3 new licences issued, 6 licences suspended, and 1 licence revoked. Clear here for a summary and for links to more details.

TGA has adopted 23 international scientific guidelines after a public consultation process – they are listed here.

* Suppliers of complementary medicines containing herbs should read the European Medicines Agency Guideline on quality of herbal medicinal products/traditional herbal medicinal products – published here.

* Guideline on manufacture of the finished dosage form is here

* Guideline on Stability Testing: Stability testing of existing active substances and related finished products is here (we are updating our course on stability testing – are you interested?)

Guideline on the quality of water for pharmaceutical use – International Scientific Guideline has been adopted, Source: TGA

Poisons Standard 

* Some responses to public submissions are published here.

* How to amend the poisons standard – application form updated 14th July, here.

TGA’s freedom of disclosure (FOI) log – last updated 28th July, is here.

Annual summary Jul 2025 – Jun 2026 is here (published 13th July)

Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, Communique, Meeting 6, 14 July 2026, read more here.

Product warnings across the GLP-1 RA class of medicines have been updated due to the potential for these products to cause a rare, but severe, form of eye disorder. The high-profile glucagon-like-peptide-1 receptor agonist (GLP-1 RA) class of prescription medicines are used primarily to manage type 2 diabetes mellitus and obesity. More here and here.

Medicines and medical devices that have been cancelled or suspended and no longer appear in the ARTG – updated 6th July.

Nicotine pouches

*new regulations restricting access to nicotine pouches from 24 July 2026, summarised here.

* How nicotine pouches are regulated in Australia – It is illegal for retailers, including online sellers, to sell nicotine pouches in Australia. Updated 17th July

Guide to prepare a cover letter for an over-the-counter (OTC) medicine application updated 9th July, read it here.

Compliance activity – Compliance enforcement

* Infringement notices: a list of infringement notices issued in response to breaches, updated 28th July published on this webpage Also refer to Information about Infringement notices – updated 3rd July here

* Cellife Health Care issued infringement notice for $19,800 (paid in July) for alleged breach of child‑resistant packaging requirements. The product did not have the required child-resistant packaging, where the level of iron in the medicine exceeded the threshold at which child-resistant packaging is required. Source: TGA

* TGA, NT Health, Northern Territory Police Force and the Northern Territory Department of Trade, Business and Asian Relations, seized more than 6,000 illegal vaping goods and more than 17,900 nicotine pouches from a retail premises and two associated storage units, more than 350,000 illicit cigarettes and over 280 kilograms of loose-leaf tobacco. Source: TGA

* Acacia Pharmacy was issued 5 infringement notices totalling $99,000 (paid in June) for unlawful importation of unapproved melatonin products, More here,

* Canngea Pty Ltd issued infringement notices totalling $59,400 for alleged failure to comply with a request for information about the supply of therapeutic vaping goods. Canngea has agreed to pay the infringement notices. Read more here.

* A nurse has been issued with 3 infringement notices totalling $11,880 for import of unapproved vials of botulinum toxin and pre-filled syringes containing lidocaine. Source: TGA

Compliance actions and outcomes – TGA responses to breaches such as warnings, fines and legal action. Summary updated 3rd July, here.

Unapproved peptide product promoters and suppliers are put on notice. Products continue to be promoted online for weight loss, anti-ageing, muscle growth, performance enhancement and cosmetic purposes but serious health risks to consumers. Source: TGA

Recalls

* Procedure for recalls, product alerts and product corrections – Questions and answers updated 14th July and published here

* Key Sun Laboratories recalling thirteen (13) batches of Key Sun Kids Homeopathic Products, due to the risk of a small metal wire being present in the lozenge. Source: TGA

Varying biological entries on the ARTG – updated July 14th here – (you will need a cup of tea to help you go through this lengthy document)

Safety advisories

* Counterfeit ‘honey’ sachets for sexual enhancement – 5 imported unapproved imported products were tested and found to contain undeclared tadalafil: Black Horse Honey sachets, Royal Honey VIP sachets, Vital Honey sachets, Helmi’s Honey sachets, Etumax Royal Honey sachets. Source: TGA )

* SARMS: TGA Laboratory testing of Eagle Research Lab SR-9009, S-23, YK-11 and RAD-140 has found that these products contain significantly less active ingredient than stated on the label. The [products are not included in the Australian Register of Therapeutic Goods and have not been assessed by the TGA for quality, safety or efficacy. Supplying unapproved products is illegal. Source: TGA

* Imported unapproved  ITCHAA SSS capsules marketed for weight management have been found to contain oxedrine, an undisclosed prescription-only medicine found in Citrus aurantium which may have serious side effects. Source: TGA

Safety alert – Withania somnifera (Ashwagandha) – update: cases of liver injury associated with Withania somnifera continue to be reported both in Australia and internationally – it may be associated with liver injury in very rare cases. Source: TGA

Medicinal cannabis vaping devices

* Checklist that helps sponsors and manufacturers identify relevant industry standards and evidence needed to demonstrate compliance of medicinal cannabis vaping devices. Published here

* Information for importers, exporters, and manufacturers about product quality, manufacturing standards, and reporting requirements updated 7th July, published here.

Vaping: Notified vape list, goods for smoking cessation or nicotine dependence that can legally be supplied, updated 2nd July here.

Medical devices

A list of Artificial Intelligence (AI) enabled medical devices included in the Australian Register of Therapeutic Goods updated 27th July is available here

The EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition. Health care providers and consumers can use the service to find out about changes to devices. Read more here.

Post-market review of plastic syringes – 27th July update is here.

Database of Adverse Event Notifications (DAEN) for medical devices – updated 17th July (editor’s note: that was my birthday!) – also how to use the database is here  

Medical device Conformity Assessment application – a 2nd July revised form has been published here

Additional medical device news can be viewed in the July 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting

Updated TGA contact details here.

Botanical Adulterants Prevention Programme (BAPP) and similar articles supplied by Michael D. Levin of Health Business Strategies LLC 

* Ashwagandha safety and efficacy: one article published in Phytotherapy Researchand another one is here.

* Adulteration of cordyceps, identifying falsified products. Published here

* Authentication of ginseng species – Journal of Dietary Supplements

* Adulteration of English Lavendar oil, on LinkedIn

For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.

IN THE PRESS

* Telehealth peptide prescriptions expose longevity industry stretching the rules – looks at the ethics of some telehealth companies. Published on ABC website

* AstraZeneca to provide breast cancer and endometriosis drug Zoladex to patients for free indefinitely. Published on ABC website

Foods