Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Nutrient Reference Values being revised (6 June 2011)
In 2006, the Nutrient Reference Values replaced the 1991 Recommended Dietary Intakes for Use in Australia (RDIs). The FSANZ website states that NRVs "indicate the daily amount of nutrients required for good health, as well as a safe intake of nutrients".
Goods that are excluded from being therapeutic goods (6 June 2011)
The new order describes those products that are declared not to be therapeutic goods.
TGA advice for applications for registered complementary medicines (6 June 2011)
Very few applications are submitted for registration of commentary medicines, as the listing process is an easier path to market. New TGA advice has been posted on their website.
Review of OTC medicine guidelines (6 June 2011)
The TGA has commenced a review of the 2003 Australian regulatory guidelines for OTC medicines and is inviting input from stakeholders (Source: www.tga.gov.au)
Warning notice – Keratin Complex Intense Rx
1 June 2011 - The government has issued a warning to consumers that Keratin Complex Intense Rx contains excessive levels of formaldehyde which can cause severe skin reactions and even cancer after exposure to chronic high exposure.