European Union guidelines used by the Office of Complementary Medicines

Please note: Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation.

Herbal medicinal products

CPMP/QWP/2819/00 (pdf,73kb)
Note For Guidance on Quality of Herbal Medicinal Products
Published: TGA Internet Site: 7 April 2003
This guideline has been included for the reference of complementary medicine sponsors seeking guidance in addition to that provided in the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

CPMP/QWP/2820/00 (pdf,159kb)
Note For Guidance on Specifications: Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products
Published: TGA Internet Site: 7 April 2003
This guideline has been included for the reference of complementary medicine sponsors seeking guidance in addition to that provided in the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).