Regulatory Compliance & Good Manufacturing Practice (GMP)

Herbs, vitamins, minerals and other health supplements in dosage form are regarded as Complementary Medicines by the Australian Government and are regulated as therapeutic goods by the Therapeutic Goods Administration (TGA) which falls under the jurisdiction of the Commonwealth Department of Health and Ageing. In contrast the same supplements in the United States and many other countries are regulated as dietary supplements, not medicines.

In Australia prescription medicines and most over-the-counter (OTC) medicines are registered and labelled with an AUST R. number. These registered medicines usually carry a high level claim of efficacy for a serious disease which requires evaluation for quality, safety and efficacy.

Complementary medicines are ‘Listed’ and are labelled with an AUST L. number following assessment by the TGA for quality, safety and efficacy. Sponsors must hold traditional or scientific evidence to support their label claims.

This assessment process ensures Australian consumers have complementary medicines produced at a high level of quality control.

Manufacturers of Australian therapeutic goods, regardless of their origin must be in compliance with the Australian Code of Good Manufacturing Practice (GMP). This means the manufacturer is audited regularly by the Audit & Licensing section of the TGA to ensure that the strict code of manufacturing practice is maintained. Nature’s Sunshine Products Inc. (U.S.A.) has successfully completed all audits carried out on their Spanish Fork manufacturing facility.