On 3 July Clexane 80 mg and 100mg were issued a recall on four additional batches of the anticoagulant (blood-thinning) medicine which were found to contain the contaminant over-sulphated chondroitin sulphate (OSCS). This is in addition to seven batches of the product recalled previously on April 22nd, May 27th and June 17th. (Sponsor Sanofi-aventis Australia)
Therapeutic goods (listing) notice
Arabinogalactan - Larix, is now permitted as an active ingredient in listed medicines provided it complies with the following requirements:
it is derived from Larix occidentalis or Larix larcinia;
the concentration of polysaccharides is greater than or equal to 85 percent; and
the maximum recommended daily dose of the ingredient is not to exceed 15 grams.
TGA eBusiness services (eBS)
The TGA is releasing an upgraded version of the Online Services Internet site that will replace the current multi-point access online interface (SIME). It amalgamates draft applications into the one filterable view; facilitates their final submission to the TGA and provides easier access for sponsors seeking information about their entries on the ARTG and TGA approved terminology.
CMEC 66th meeting
The Complementary Medicines Evaluation Committee 66th Meeting on April 18, made the following recommendations to the TGA:
- Ligusticum lucidum is not suitable for use as an ingredient in Listed medicines.
- the current label warning statement for products containing from 50 to 200 mg vitamin B6 (pyridoxine, pyridoxal, pyridoxamine) per recommended daily dose be amended as follows: for single ingredient products: "WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible." For multi-ingredient products:
"WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6."
- the use of Caesalpinia sappan as an ingredient in Listed medicines should be limited to traditional preparations of the heartwood.
- only an essential oil preparation of the wood of Cedrus atlantica, when administered topically or via inhalation, is suitable for use in Listed medicines.
- the use of Selaginella tamariscina as an ingredient in Listed medicines should be limited to traditional preparations of the herb.
- the use of Psoralea corylifolia as an ingredient in Listed medicines should be limited to preparations of the fruit/seed containing less than 1.1 per cent psoralen per recommended daily dose. Also an advisory statement, informing consumers of the photosensitizing potential of psoralen, is recommended to be included on any product containing preparations of Psoralea corylifolia. Read more
CMEC 67th meeting
The Complementary Medicines Evaluation Committee 67th Meeting on June 20, made the following recommendations to the TGA:
- only the stir-fried burs of Xanthium sibiricum and Xanthium strumarium, prepared according to the monograph for 'Fructus Xanthii (stir-baked)' in the Pharmacopoeia of the People's Republic of China (2005), are suitable for use as an active ingredient in Listed medicines, at a maximum recommended daily dose of 9 g.
- only preparations of the rhizome of Ligusticum wallichii are suitable for use as an ingredient in Listed medicines.
- only preparations of the root and rhizome of Ligusticum sinense are suitable for use as an ingredient in Listed medicines.
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Guidance on changes to ELF 3
Following the inclusion of a product as a Listed medicine in the ARTG, sponsors may wish to change certain details previously advised to the TGA. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry is necessary and the regulatory impact that making certain changes to currently Listed products may have.Read more ...
Required advisory statements for medicine labels - proposed changes
A consultation document is available to advise stakeholders of the proposed changes to the Required Advisory Statements for Medicine Labels dated April 2008 (RASML). These changes include pregnancy related advisory statements on aspirin containing products and a new advisory statement for anticholinergic products. Comment is requested by 31 July.
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Therapeutic excluded goods order No 1
The Therapeutic Goods Order No 1 was gazetted in June and outlines goods declared not to be therapeutic goods. A new category of product has been added these were previously regulated as therapeutic goods and are now regulated as cosmetics: Goods that are not therapeutic goods, with allowable limited therapeutic use when advertised, represented or presented for supply in a particular way.
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Declaration of low volume low value turnover therapeutic goods
An application form is available for declaring products with turnover of low volume and low value for 07/08 and 08/09.
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Annual charges invoices for the 2008/09 financial year should have been received by sponsors by July 11, 3 weeks earlier than in the previous year which allows sponsors more time to review all their ARTG listings. Sponsors will have more than two months to review the product range listed in the invoice and identify products which should be cancelled (where supply ceased before 1 July 2008) and products for which an LVLV exemption will be sought. The due date for payment of the invoice will be 1 October 2008.
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Recall coordinators' contact details (updated June 2008)
TGA business plan 2008-2009
Advice from TGA on Gardasil (Human papillomavirus vaccine)
TGA open day 24 August