Very Important Information for All Sponsors of Listed Complementary Medicines

Details of all products listed on the Australian Register of Therapeutic Goods (ARTG) must now be changed to ensure that:

  • Previously permitted ‘free text’ indications are removed.
  • All indications must be selected from the revised list of permitted indications
  • These changes are mandatory. Updates to change indications will not incur a TGA fee until 6th September 2019. Each product not revised before 6th September 2019 will incur a TGA fee for the change.
  • The transition period to relist ALL products with permitted indications expires on 6th March 2021. Listed medicines not transitioned by 6th March 2021 will be cancelled!

Updated Therapeutic Goods Act is Now Law

As detailed in the last two recent editions of this newsletter, the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by both houses of Parliament on 15th February 2018. The compilation of the Therapeutic Goods Act 1989 (‘the Act’), which now incorporates the amendments from the Therapeutic Goods Amendment Bill No. 1 of 2017 legally effective from 6 March 2018, has now been uploaded onto the Federal Register of Legislation (FRL). The new Act incorporates significant amendments to the regulatory framework for complementary medicines, including introduction of the permitted indications, relevant changes to sponsor certifications under the Act, the introduction of the new pathway for complementary medicines, and a new advertising framework.    Source: TGAact 1989

TGA Announces Updates to the Permissible Ingredients Determination For Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in March 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018. A total of 64 changes have been made in the updated Determination. These changes include: The addition of 4 new ingredients; changes to 56 existing ingredient entries (including, making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use; making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and making minor changes to make a number of entries clearer); and, the removal of 4 ingredients that have been determined not to be suitable for inclusion in listed medicines or were synonymous with other existing ingredients to avoid duplication. A complete list of changes to ingredient availability can be read here: Permissible ingredients update  

TGA Releases Assessed Listed Medicines Evidence Guidelines

The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). The new pathway sits between the current listed (lower risk) and the registered (higher risk) pathways. It enables sponsors to list products with higher level indications than permitted in standard listed medicines without having to meet the extensive requirements for full registration. This is provided that assessed listed medicines have robust scientific evidence to support the efficacy of the product, and this evidence is pre-market assessed by the TGA. This guidance applies to 'assessed listed medicines' that are eligible for evaluation by the TGA's Complementary and Over-the-counter Medicines Branch (COMB).     Sources: ALM guidelines & ALM pathway

(Editor’s note: These are the most significant changes to complementary medicine legislation in a generation. If you think that your product may be better marketed as an ‘assessed listed medicine’ then please feel free to contact RFA Regulatory Affairs for more detailed and confidential advice).


Country of Origin Labelling for Complementary Healthcare Products - A Guide For Business

The Australian Competition & Consumer Commission has prepared this guide to assist the complementary healthcare industry to understand how the safe harbour defences set out in section 255 of the Australian Consumer Law apply to their products. It is intended to supplement the information in the ACCC’s Country of origin claims and the Australian Consumer Law publication. (Please note this document does not constitute legal advice. The ACCC always recommends that businesses seek independent advice when deciding which origin claims to make about their products). This guide will assist businesses to understand the application of the Australian Consumer Law (ACL) in relation to country of origin claims and in particular, when businesses can safely make a ‘made in’ claim about their products. In contrast to origin labelling requirements for food products, neither the ACL or the Therapeutic Goods Act 1989 require complementary medicine products to carry country of origin labelling. However, if companies choose to make such claims they must be aware of the laws against false, misleading or deceptive claims.   Sources: CoOL CMeds.pdf & CoOL ACL (Editor’s note: Please see related story under 'Foods', in this newsletter)

TGA Safety Advisories—

LIPRO Dietary capsules – the capsules contain the undeclared substances sibutramine and diphenhydramine   Source: LIPRO caps

Gold Viagra 9800mg capsules - the capsules contain the undeclared substance sildenafil.   Source: Gold viagra caps

ViaGro 500mg Male Enhancement capsules - the capsules contain the undeclared substances theophylline and caffeine.   Source: ViaGro 500 caps

Black Ant King tablets - The Therapeutic Goods Administration has tested a product labelled Black Ant King tablets and found that the tablets contain the undeclared prescription only substances sildenafil and chloramphenicol.   Source: Black ant tabs

Vegetal Vigra capsules - the capsules contain sildenafil.   Source: Vegetal vigra caps

Stree Overlord Strong tablets - the tablets also contain sildenafil.   Source: Stree tabs


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Details at the bottom of this newsletter.


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