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European Union guidelines published as NOT adopted in Australia

24 January 2017

The guidelines on this page have NOT been adopted in Australia. For adopted guidelines see: EU guidelines ADOPTED in Australia

CHMP/5579/04 Rev 1
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

CHMP/BWP/2458/03
Guideline on Development and Manufacture of Lentiviral Vectors

Published: TGA Internet site 15 June 2006

CHMP/SWP/4447/00
Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use

Published: TGA Internet site 29 September 2006

CHMP/VWP/382702/2006
Guideline on clinical Evaluation of New Vaccines Annex: SPC Requirements

Published: TGA Internet site 6 January 2009

CPMP/180/95
Guideline for PMS Studies for Metered Dose Inhalers with New Propellants

Published: TGA news August 1997

CPMP/328/98 Rev 3
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
Guideline on the Acceptability of invented names for human medicinal products processed through the centralised procedure

Published: TGA Internet site 24 November 2004

CPMP/1100/02
Note for Guidance on the Development of Vaccinia Virus based Vaccines against Smallpox

Published: TGA Internet site 10 February 2009

CPMP/3070/01
Position Paper on Terminology in Pharmacogentics

Published: TGA Internet site 29 September 2006

CPMP/4548/03
Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification

Published: TGA Internet site 7 September 2004

CPMP/BPWG/282/00
Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use

Published: TGA Internet site 12 March 2003

CPMP/BPWG/574/99
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
Note for Guidance on Core SPC for Human Immunoglobulin for Intravenous Administration (IVIg)

Published: TGA Internet site 19 April 2001

CPMP/BPWG/1619/99
Core SPC for Human Plasma Derived and Recombinant Coagulation Factor VIII Products

Published: TGA Internet site 19 April 2001

CPMP/BPWG/1625/99
Core SPC for Human Plasma Derived and Recombinant Coagulation Factor IX Products

Published: TGA Internet site 19 April 2001

CPMP/BPWG/3226/99
Core SPC for Human Plasma Derived Antithrombin

Published: TGA Internet site 5 March 2003

CPMP/BPWG/BWP/561/03
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

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CPMP/BWP/1571/02
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
Guideline on Requirements for Plasma Master File (PMF) Certification

Published: TGA Internet site 16 August 2004

CPMP/BWP/41450/98
Points to Consider on the Manufacture and Quality Control of Somatic Cell Therapy Medicinal Products

Published: TGA Internet site 10 January 2002

CPMP/BWP/2758/02
Guideline on Pharmaceutical Aspects of the Product Information for Human Vaccines

Published: TGA Internet site 13 January 2005

CPMP/BWP/2879/02
CPMP Position Statement on Creutzfeldt-Jakob Disease and plasma-derived and urine-derived medicinal products

Published: TGA Internet site 25 February 2004

CHMP/GTWP/125491/2006
Guideline on Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products

Published: TGA Internet site 25 March 2009

CPMP/ICH/288/95
Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

Published: TGA Internet site 10 October 2002

CPMP/PhVWP/005/96
Rapid Alert System (RAS) in Pharmacovigilance

Published: TGA news August 1997

CPMP/PhVWP/108/99 Corr
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
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
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
Core SPC for Human Albumin

Published: TGA Internet site 24 October 2002

CPMP/QWP/576/96 rev 1
Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation

Published: TGA Internet site 20 January 2009

CPMP/QWP/609/96
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

CPMP/VEG/4986/03
Guideline on Submission of Marketing Authorisation Applications for Pandemic Influenza Vaccines Through the Centralised Procedure

Published: TGA Internet site 16 August 2004

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EDQM Guideline
EC Administrative Procedure for Official Control Authority Batch Release (OCABR) 2001

Published: TGA Internet site 27 March 2002

EDQM OCABR # 05 - 2001
Solvent Detergent (SD) Plasma

Published: TGA Internet site 22 May 2002

EDQM OCABR # 09 - 2001
Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)

Published: TGA Internet site 22 May 2002

EDQM OCABR # 12 - 2001
Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine

Published: TGA Internet site 22 May 2002

EDQM OCABR # 17 - 2001
Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed)

Published: TGA Internet site 22 May 2002

EDQM OCABR # 18 - 2001
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
Mumps Vaccine

Published: TGA Internet site 22 May 2002

EDQM OCABR # 36 - 2001
Tick-Borne Encephalitis (TBE) Vaccine

Published: TGA Internet site 22 May 2002

EDQM OCABR # 39 - 2002
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

EMA/CHMP/GTWP/212377/2008
Questions and Answers on Gene Therapy
Published: TGA Internet site 5 November 2010

EMEA/106464/2006 Rev 1
Guideline on the use of Statistical Signal Detection Methods in the Eudravigilance Data Analysis System

Published: TGA Internet site 25 March 2009

EMEA/CHMP/BWP/473191/2006 - Corr
Guideline on Environmental Risk Assessments for Medicinal Products Consisting of, or Containing, Genetically Modified Organisms (GMOs)

Published: TGA Internet site 26 March 2010

EMEA/CHMP/EWP/692702/2008
Reflection Paper on Extrapolation of Results from Clinical Studies Conducted Outside the EU to the EU-Population

Published: TGA Internet site
Effective: 28 May 2010

F2/AN D(2002) (part of EudraLex Volume 2C)
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

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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/3380/93
CORE SPC - INDIUM [111In] CHLORIDE, PRECURSOR SOLUTION

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
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

European Medicines Agency
European Medicines Agency (EMA)

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