Application guidelines
European Union guidelines adopted in Australia
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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 Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)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
Application guidelines
Common Technical Document (CTD) Format
Published: TGA Internet site
Effective: 14 October 2002
CPMP/ICH/5552/02 Rev 2 (pdf,162kb)
General Questions and Answers. Common technical document for the registration of pharmaceuticals for human use - Step 5
Published: TGA Internet site
Effective: 7 October 2004
CPMP/VEG/4717/03 (pdf,255kb)
Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application
Published: TGA Internet site
Effective: 16 August 2004
The European Agency for the Evaluation of Medicinal Products (EMEA)