Guidelines used by the Office of Complementary Medicines
European Union guidelines adopted in Australia
To search for a guideline by key word on this page, use your browser's 'Find' function (Control-F or Edit, Find in most browsers).
AGRD refers to: Australian Guidelines for the Registration of Drugs, Volume I, second edition, July 1994 (Australian Government Publishing Service). Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
ARGPM refers to: Australian Regulatory Guidelines for Prescription Medicines, June 2004. Published on the Therapeutic Goods Administration (TGA) Internet site
Rules 2001 (Vol. 9) refers to: EU Pharmacovigilance Rules for Human and Veterinary Medicinal Products - EudraLex Volume 9 - December 2001
Rules 1989 refers to: The Rules Governing Medicinal Products in the European Community Volume III 1989 - Guidelines on the quality safety and efficacy of medicinal products for human use
Rules Addendum refers to: The Rules Governing Medicinal Products in the European Community Volume III Addendum July 1990 - Guidelines on the quality safety and efficacy of medicinal products for human use
Rules 1998 (3A) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3A - Quality and Biotechnology
Rules 1998 (3B) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3B - Safety and the Environment
Rules 1998 (3C) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3C - Efficacy and information on the medicinal product
Rules 1997 (4) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human and veterinary use, 1997 Edition: Volume 4 - Pharmaceutical Legislation - Good Manufacturing Practices
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)."
The European Agency for the Evaluation of Medicinal Products (EMEA)