Extracted ratified minutes

How to access a pdf document

CMEC Meeting 16 extracted ratified minutes (pdf,31kb)

Public recommendation summary

Item 3 Report of the Working Party on Substantiation of Claims

Recommendation 16.1

CMEC endorses the amended document Standards for levels and kinds of evidence to support claims for therapeutic goods, noting that during the implementation process CMEC may need to further refine aspects of it.

Item 5.1 Colloidal silica

Recommendation 16.2

CMEC recommends to the TGA that colloidal anhydrous silica and silicon dioxide (otherwise known as colloidal hydrated silica) are suitable for use as active ingredients in listable therapeutic goods, other than in goods where the dosage form is a powder.

Item 6.1 Fish oils

Recommendation 16.3

CMEC recommends to the TGA that the existing permission within the Therapeutic Goods Regulations to use fish oils as active ingredients in therapeutic goods be amended to remove the requirement that the fish oils can only be used if they are sources of either vitamins or omega-3 marine triglycerides. CMEC also recommends that no daily dose limits or specific label advisory statements be required when fish oils are used in listable therapeutic goods. However, prior to the implementation of these recommendations, CMEC further recommends that the TGA develops compositional specifications for fish oils that are not already covered by pharmacopoeial monographs, and seeks broad comment on these specifications.

Top of page