Product recalls
On 29 October Dymatize Nutrition Anabolic Meth-X 100 capsules were issued a Class I Recall. This product has been found to contain the prescription only substance Ipriflavone and as such should only be used under the direction of a Doctor. (Sponsor – Superior Supplements) Read more …
On 29 October Physio Care Lida Dai Dai Hua Jiao Nang Slimming Capsules were issued a Class I Recall. The product has been found to contain a derivative of SIBUTRAMINE, which is a prescription only substance that should only be used under the supervision of a Doctor. (Sponsor – Phsyio Care) Read more …
On 22 October VPX 'No Shotgun' & BSN 'Cell Mass' Body Building Powders were issued a Class I Recall. These products contain traces of the prescription drug coumarin. (Sponsor – Crestkey Pty Ltd)
Read more …
On the 19 October the TGA issued a health alert that a South Australian company, Mekong Grocery is undertaking a consumer level recall of Lida Daidaihua Slimming Capsules as it contains an undeclared pharmaceutical ingredient (a derivative of sibutramine, a prescription only substance). This product is not currently approved for supply in Australia.
Read more …
The consumer alert can be viewed here …
[Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]
Use of modified unprocessed herbal and biological materials in CMs
A guidance document has been drafted by the Office of Complementary Medicine (OCM), in collaboration with the OCM / Industry Consultation Group (OICG), as an adjunct guideline to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM). The draft guidance document applies to unprocessed herbal and biological materials whose composition has been chemically modified to the extent that it is significantly different from the original material approved for use in Listed or Registered medicines. Submissions on the adequacy or otherwise relevance of the draft document are being sought before finalisation of the guideline. Read more …
Equivalence of herbal extracts
Another draft guidance document has been drafter by the OCM in collaboration with the OICG, as an adjunct guideline to the ARGCM. This guidance document has been developed in recognition of the fact that there are some situations where a sponsor or manufacturer may need to accept extracts with slightly different extractions profiles to those recorded in ARTG. This draft guidance document describes the circumstances under which herbal extracts may be considered to be 'equivalent', and where a sponsor/manufacturer may substitute an ingredient, without the product becoming a separate and distinct good. Read more …
Required advisory statements for medicine labels
A consultation document is available outlining the proposed changes to the Required Advisory Statements for Medicine Labels (edition 1, including update 3.1). Request for review and comment on the changes has been made.
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Complementary Medicine Evaluation Committee 63rd meeting
Recommendations to the TGA from the 63rd CMEC meeting include:
~ Rhodiola rosea dried root (powdered), its aqueous extract and its hydroethanolic extracts (up to 70% ethanol v/v) are suitable for use as ingredients in listed medicines, following finalisation of a compositional guideline.
~ a warning statement be included on the labels of all preparations for oral use containing selenium with a recommended daily dose of 150 mcg or less of selenium.
~ three warning statements be included on the labels of preparations for internal use containing 3,000 mcg retinol equivalents or less of vitamin A other than those containing a)33 µg retinol equivalents or less of vitamin A per dosage unit of a divided preparation; or b) 33 µg retinol equivalents or less of vitamin A per gram of an undivided preparation.
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Evidence summary table for listed medicines
The TGA recommends that sponsors use a standard format, provided by the TGA, to summarise evidence they hold to support the claims/indications made for listable medicines. Read more …
Australian adverse drug reactions
Issue 26, volume 5 of the Australian Adverse Drug Reaction Bulletin reported on the dangers associated with chronic ingestion of colloidal silver.
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TGA business plan
The quarterly report for April-June 2007 has been issued. Read more …
Transfer of sponsorship on the ARTG
Forms are available for:
Relinquishing company requesting to transfer sponsorship on the ARTG here …
Accepting company requesting transfer of sponsorship on the ARTG here …
