02.06.2010
Attached is a letter from the TGA advising of the adoption of a new code of GMP in Australia that takes effect from 1 July.
All NZ companies exporting natural products (complementary medicines) to Australia need to make themselves familiar with the implications of the new code of manufacture for your company and/or the contract manufacturer who produces your products.
The new Manufacturing Principle mandates the use of a new code of Good Manufacturing Practice (2009 GMP Guide) by adopting the PIC/S Guide for Good Manufacturing Practice for Medicinal Products –15 January 2009 (PE 009-8) http://www.tga.gov.au/manuf/picsgmpmed.htm
From 1 July there will be one standard (2009 GMP Guide) applicable to all medicinal products including: Prescription medicines, OTC medicines, complementary medicines, Active Pharmaceutical Ingredients (APIs), and Sunscreens (revoking the Australian Code of GMP for Sunscreens products –February 1994). Refer http://www.tga.gov.au/docs/html/gmpcodes.htm
Best regards
Michelle