European Union guidelines published as NOT adopted in Australia
For adopted guidelines see: EU guidelines ADOPTED in Australia
CPMP/180/95
Guideline for PMS Studies for Metered Dose Inhalers with New Propellants
Published: TGA news August 1997
CPMP/328/98 Rev 3 (pdf,143kb)
Guideline on the Acceptability of Invented Names for Human Medicinal Products processed through the Centralised Procedure
Published: TGA Internet site 4 June 2002
CPMP/328/98 Rev 4 (pdf,88kb)
Guideline on the Acceptability of invented names for human medicinal products processed through the centralised procedure
Published: TGA Internet site 24 November 2004
CPMP/BPWG/282/00 (pdf,185kb)
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use
Published: TGA Internet site 12 March 2003
CPMP/BPWG/574/99 (pdf,52kb)
Core SPC for Human Anti-D Immunoglobulin for Intravenous and / or Intramuscular Use
Published: TGA Internet site 19 April 2001
CPMP/BPWG/859/95 Rev 1 (pdf,48kb)
Note for Guidance on Core SPC for Human Immunoglobulin for Intravenous Administration (IVIg)
Published: TGA Internet site 19 April 2001
CPMP/BPWG/1619/99 (pdf,67kb)
Core SPC for Human Plasma Derived and Recombinant Coagulation Factor VIII Products
Published: TGA Internet site 19 April 2001
CPMP/BPWG/1625/99 (pdf,69kb)
Core SPC for Human Plasma Derived and Recombinant Coagulation Factor IX Products
Published: TGA Internet site 19 April 2001
CPMP/BPWG/3226/99 (pdf,167kb)
Core SPC for Human Plasma Derived Antithrombin
Published: TGA Internet site 5 March 2003
CPMP/BPWG/BWP/561/03 (pdf,198kb)
Note for Guidance on the Warning on Transmissible Agents in Summary of Product Characteristics (SPCs) and Package leaflets for Plasma-Derived Medicinal Products
Published: TGA Internet site 2 May 2005
EMEA/CPMP/BWP/1571/02 (pdf,105kb)
CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
Published: TGA Internet site 2 May 2005
CPMP/BWP/4663/03 (pdf,218kb)
Guideline on Requirements for Plasma Master File (PMF) Certification
Published: TGA Internet site 16 August 2004
CPMP/BWP/41450/98 (pdf,83kb)
Points to Consider on the Manufacture and Quality Control of Somatic Cell Therapy Medicinal Products
Published: TGA Internet site 10 January 2002
CHMP/BWP/2458/03 (pdf,200kb)
Guideline on Development and Manufacture of Lentiviral Vectors
Published: TGA Internet site 15 June 2006
CPMP/BWP/2879/02 (pdf,215kb)
CPMP Position Statement on Creutzfeldt-Jakob Disease and plasma-derived and urine-derived medicinal products
Published: TGA Internet site 25 February 2004
CPMP/ICH/288/95 (pdf,150kb)
Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
Published: TGA Internet site 10 October 2002
CPMP/ICH/4106/00 (pdf,275kb)
Note For Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients
Published: TGA Internet site 6 February 2001
NB. This guideline has not been adopted in this format. Sponsors should refer to the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2002 on Active Pharmaceutical Ingredients, which was adopted by the TGA with effect from 29 May 2002.
CPMP/PhVWP/005/96 (pdf,76kb)
Rapid Alert System (RAS) in Pharmacovigilance
Published: TGA news August 1997
CPMP/PhVWP/108/99 Corr (pdf,236kb)
Notice to Marketing Authorisation Holders: Pharmacovigiliance Guidelines
Published: TGA Internet site 10 October 2002
CPMP/PhVWP/175/95
Note for Guidance on the Procedure for Competent
Authorities on the Undertaking of Pharmacovigilance studies
Published: TGA news August 1997
CPMP/PhVWP/2056/99 (pdf,76kb)
Note for Guidance on Electronic Exchange of Pharmacovigilance Information for Human and Veterinary Medicinal Products in the European Union
Published: TGA Internet site 15 December 2000
CPMP/PhVWP/2058/99 Rev 1 (pdf,168kb)
Joint Pharmacovigilance Plan for the Implementation of the ICH E2B, M1 and M2 Requirements Related to the Electronic Transmission of Individual Case Safety Reports in the Community
Published: TGA Internet site 30 August 2001
CPMP/PhVWP/BPWG/2231/99 (pdf,72kb)
Core SPC for Human Albumin
Published: TGA Internet site 24 October 2002
CPMP/QWP/227/02 (pdf,179kb)
Guideline on Active Substance Master File Procedure
Published: TGA Internet site 7 October 2004
CPMP/QWP/609/96 (pdf,53kb)
Note for Guidance on Declaration of Storage Conditions for Medicinal Products in the Product Particulars (Annex to Note for Guidance on Stability Testing of New Active Substances and Medicinal Products)
Published: TGA Internet site 19 April 2001
EDQM Guideline (pdf,283kb)
EC Administrative Procedure for Official Control Authority Batch Release (OCABR) 2001
Published: TGA Internet site 27 March 2002
EDQM OCABR # 05 - 2001 (pdf,113kb)
Solvent Detergent (SD) Plasma
Published: TGA Internet site 22 May 2002
EDQM OCABR # 09 - 2001 (pdf,167kb)
Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)
Published: TGA Internet site 22 May 2002
EDQM OCABR # 12 - 2001 (pdf,158kb)
Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine
Published: TGA Internet site 22 May 2002
EDQM OCABR # 17 - 2001 (pdf,163kb)
Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed)
Published: TGA Internet site 22 May 2002
EDQM OCABR # 18 - 2001 (pdf,191kb)
Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined Vaccine (Adsorbed)
Published: TGA Internet site 22 May 2002
EDQM OCABR # 30 - 2001 (pdf,164kb)
Mumps Vaccine
Published: TGA Internet site 22 May 2002
EDQM OCABR # 36 - 2001 (pdf,164kb)
Tick-Borne Encephalitis (TBE) Vaccine
Published: TGA Internet site 22 May 2002
EDQM OCABR # 39 - 2002 (pdf,15kb)
Procedure For Official Control Authority Batch Release of Centrally Authorised Immunological Medicinal Products For Human Use And Medicinal Products Derived From Human Blood And Plasma
Published: TGA Internet site 29 October 2004
EMEA/CHMP/5579/04 Rev 1 (pdf,91kb)
Guideline on Procedural Aspects Regarding a CHMP Scientific Opinion in the Context of Cooperation with the World Health Organisation (WHO) for the Evaluation of Medicinal Products Intended Exclusively for Markets Outside the Community.
Published: TGA Internet site 11 August 2006
EMEA/CHMP/SWP/4447/00 (pdf,133kb)
Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use
Published: TGA Internet site
Effective: 29 September 2006
EMEA/CPMP/3070/01 (pdf,173kb)
Position Paper on Terminology in Pharmacogentics
Published: TGA Internet site
Effective: 29 September 2006
EMEA/CPMP/4548/03 (pdf,251kb)
Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification
Published: TGA Internet site 7 September 2004
EMEA/CPMP/BWP/2758/02 (pdf,195kb)
Guideline on Pharmaceutical Aspects of the Product Information for Human Vaccines
Published: TGA Internet site 13 January 2005
EMEA/CPMP/VEG/4986/03 (pdf,223kb)
Guideline on Submission of Marketing Authorisation Applications for Pandemic Influenza Vaccines Through the Centralised Procedure
Published: TGA Internet site 16 August 2004
F2/AN D(2002) (part of EudraLex Volume 2C) (pdf,400kb)
Notice To Applicants - Guideline On The Categorisation of New Applications (Na) versus Variations Applications (V) - January 2002
Published: TGA Internet site 21 August 2002
III/3111/93
CORE SPC - I-125 ALBUMIN INJECTION
Published: TGA Internet site 15 December 2000
III/3113/93
CORE SPC - I-131 ALBUMIN INJECTION
Published: TGA Internet site 15 December 2000
III/3117/93
CORE SPC- KIT FOR PREPARATION OF TECHNITIUM [99mTc] HUMAN ALBUMIN INJECTION
Published: TGA Internet site 15 December 2000
III/3118/93
CORE SPC - KIT FOR PREPARATION OF TECHNITIUM [99mTc] MACROSALB INJECTION (MAA)
Published: TGA Internet site 15 December 2000
III/3119/93
CORE SPC - KIT FOR PREPARATION OF TECHNITIUM [99mTc] MICROSPHERES INJECTION
Published: TGA Internet site 15 December 2000
III/3120/93
CORE SPC - TECHNITIUM [99mTc] SUCCIMER (DMSA) SOLUTION FOR INJECTION
Published: TGA Internet site 15 December 2000
III/3121/93
CORE SPC - TECHNITIUM [99mTc] PENTETATE (DTPA) SOLUTION FOR INJECTION
Published: TGA Internet site 15 December 2000
III/3122/93
CORE SPC - TECHNITIUM [99mTc] GLUCONATE SOLUTION FOR INJECTION
Published: TGA Internet site 15 December 2000
III/3123/93
CORE SPC - TECHNITIUM [99mTc] GLUCEPTATE SOLUTION FOR INJECTION
Published: TGA Internet site 15 December 2000
III/3126/93
CORE SPC - I-123 NA-IODIDE (ORAL SOLUTION)
Published: TGA Internet site 15 December 2000
III/3142/93
131I IODOMETHYL NORCHOLSTEROL INJECTION
Published: TGA Internet site 15 December 2000
III/3143/93
CORE SPC - TECHNETIUM [99mTc] GENERATOR
Published: TGA Internet site 15 December 2000
III/3189/93
CORE SPC - Tc-99M ALBUMIN MICROCOLLOID MILLIMICROSPHERES
Published: TGA Internet site 15 December 2000
III/3190/93
CORE SPC - Tc-99M ALBUMIN MICROCOLLOID (MICROMETRES)
Published: TGA Internet site 15 December 2000
III/3191/93
CORE SPC - Tc-99m ALBUMIN MICROCOLLOID (NANOMETRES)
Published: TGA Internet site 15 December 2000
III/3193/93
CORE SPC - TI -201 CHLORIDE INJECTION
Published: TGA Internet site 15 December 2000
III/3246/93
CORE SPC - I-123 MIBG INJECTION
Published: TGA Internet site 15 December 2000
III/3247/93
CORE SPC - I-131 MIBG INJECTION
Published: TGA Internet site 15 December 2000
III/3381/93
CORE SPC - INDIUM [111In] OXINE, PRECURSOR SOLUTION
Published: TGA Internet site 15 December 2000
III/3415/93
CORE SPC - Y-90 COLLOIDS (INJECTION)
Published: TGA Internet site 15 December 2000
III/3454/91
Control Authority Batch Release of Adsorbed Diphtheria, Tetanus, Pertussis and Combined Vaccines - Superseded by III/3775/92 (adopted in Australia 1/1/95)
Published: TGA Internet site 23 February 2001
III/3593/91
CPMP list of allowed terms for the pharmaceutical dosage form, route of administration, container, closure and administration devices
Published: TGA Internet site 15 December 2000
III/3653/91
NOTE FOR GUIDANCE: SUMMARY OF PRODUCT CHARACTERISTICS (PART 1B) FOR BENZODIAZEPINES AS ANXIOLYTICS
Published: TGA Internet site 15 December 2000
III/3654/91
SPC (PART 1B) OF BETA-ANDRENERGIC BLOCKING AGENTS
Published: TGA Internet site 15 December 2000
III/3679/92
CORE SPC - KIT FOR THE PREPARATION OF TECHNITIUM [99mTc] COLLOID SULPHUR SUSPENSION FOR INJECTION
Published: TGA Internet site 15 December 2000
III/3680/92
CORE SPC - Tc- 99m RE-SULPHIDE COLLOID
Published: TGA Internet site 15 December 2000
III/3719/92
NOTE FOR GUIDANCE - SPC BISACODYL
Published: TGA Internet site 15 December 2000
III/3779/92
CORE SPC - Kr81m GENERATOR
Published: TGA Internet site 15 December 2000
III/3813/93
CORE SPC - I-123 Na-IODIDE
Published: GA Internet site 15 December 2000
III/3814/92
CORE SPC - I - 123 Na- IODIDE (INJECTION)
Published: TGA Internet site 15 December 2000
III/3859/92 (pdf,65kb)
Administrative EC Batch Release Procedure
Published: TGA Internet site 27 March 2002
III/3879/90
Abridged Applications
Published: TGA Internet site 6 February 2001
III/5462/93
Matters Relating to the Replacement of CFCs in
Medicinal Products
Published: TGA Internet site 6 February 2001
III/5447/94
Guideline on the Assessment Report (AR)
Published: TGA news December 1998
III/5458/93
CORE SPC - GALLIUM [67Ga] CITRATE (INJECTION)
Published: TGA Internet site 15 December 2000
III/5568/93
CORE SPC - FERRIC [59Fe] CITRATE (INJECTION)
Published: TGA Internet site 15 December 2000
III/5569/93
CORE SPC - CALCIUM [47Ca] CHLORIDE SOLUTION
Published: TGA Internet site 15 December 2000
III/5573/93
CORE - SPC - CYANOCOBALAMIN [57Co] CAPSULES
Published: TGA Internet site 15 December 2000
III/5574/93
CORE SPC - CYANCOBALAMIN [58Co] SOULUTION
Published: TGA Internet site 15 December 2000
III/5575/93
CORE SPC - CAPSULE CYANOCOBALAMIN [57Co] BOUND TO HUMAN GATRIC JUICE; CAPSULE CYANOCOBALAMIN [58Co]; AMPOULE CYANCOBALAMIN FOR INTRAMUSCULAR INJECTION
Published: TGA Internet site 15 December 2000
III/5627/93
CORE SPC - SODIUM CHROMATE [51CR] SOLUTION
Published: TGA Internet site 15 December 2000
III/5880/94
Mutual recognition of the Summary of Product Characteristics (SPC)
Published: TGA Internet site 6 February 2001
III/9163/90
Summary of Product Characteristics
Published: TGA Internet site 10 January 2002
The European Agency for the Evaluation of Medicinal Products (EMEA)