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Part IV Pre-Clinical and Clinical Trial PDF Print E-mail
Written by Eva Vernerová   

The particulars and documents, which shall accompany applications for marketing authorisations pursuant to the third indent of Article 12(3)(j) shall be submitted in accordance with the requirements of Annex I of Directive 2001/82/EC. The specific efficacy guidelines are published on the EMEA website under: http://www.emea.europa.eu/htms/vet/vetguidelines/efficacy.htm 

General

NázevČísloDatum platnostiZdrojPoznámka/dokument
Fixed combination productsEMEA/CVMP/83804/05July 2007 EMEA 
Statistical principles for veterinary
clinical trials
EMEA/CVMP/816/00December 2001 EMEA 
VICH GL9: Good clinical practicesEMEA/CVMP/VICH/
595/98
July 2000 EMEA 

Pre-clinical

NázevČísloDatum platnostiZdrojPoznámka/dokument
Evaluation of the safety of veterinary
medicinal products for target
animals
7AE2a Volume 7September 1994 EMEA 
VICH GL43: Target Animal Safety:
Pharmaceuticals
CVMP/VICH/393388/06July 2009 EMEA 
Conduct of bioequivalence studies
for veterinary medicinal products
EMEA/CVMP/016/00
- Rev. 1
July 2001 EMEARevision: Conduct
of bioequivalence studies
for veterinary medicinal
products
Conduct of pharmacokinetic studies
in target animal species
EMEA/CVMP/133/99September 2000 EMEA  

Specific Guidelines

NázevČísloDatum platnostiZdrojPoznámka/dokument
Dossier requirements for anticancer
medicinal products for dogs and cats
EMEA/CVMP/28510
/08
November 2009 EMEA 
Conduct of efficacy studies
for non-steroidal anti-inflammatory
drugs
EMEA/CVMP/237/01June 2002 EMEA 
Efficacy of veterinary medicinal
products for use in farmed
aquatic species
7AE22a Volume 7 September 1994 EMEARevision: Efficacy of veterinary
medicinal products for use
in farmed aquatic species
Anticoccidials for the therapy
of coccidiosis in chickens, turkeys
and geese
7AE15a Volume 7May  1993 EMEA 
Veterinary medicinal products
for zootechnical purposes
7AE7a Volume 7September 1992 EMEA 
Veterinary medicinal products
for fluid therapy in case of diarrhoea
7AE14a Volume 7September 1992 EMEA 
Veterinary medicinal products
controlling Varroa jacobsoni and Acarapis
Woodi
parasitosis in bees
7AE16a Volume 7March 1992  EMEARevision: Veterinary medicinal
products controlling Varroa
jacobsoni
and Acarapis
Woodi
parasitosis in bees
Performance enhancers7AE6a Volume 7November 1991  

Antimicrobials
NázevČísloDatum platnostiZdrojPoznámka/dokument
SPC for antimicrobial productsEMEA/CVMP/SAGAM/
383441/2005
May  2008 EMEA 
Demonstration of efficacy
for veterinary medicinal products
containing antimicrobial substances
EMEA/CVMP/627/01June 2003 EMEA 
Product for intramammary use

NázevČísloDatum platnostiZdrojPoznámka/dokument
Conduct of efficacy studies
for intramammary products
for use in cattle
EMEA/CVMP/344/99
-Rev.1
September 2000 EMEA 
Local tolerance of intramammary
preparations in cows
7AE21a Volume 7 May 1993 EMEA 

Anthelmintics

NázevČísloDatum platnostiZdrojPoznámka/dokument
SPC of anthelminticsCVMP/EWP/170208
/2005
February 2008 EMEA 
VICH GL7: Efficacy of anthelmintics:
General requirements
CVMP/VICH/832/99December 2000 EMEA 
VICH GL12: Efficacy of anthelmintics:
Specific recommendations for bovines
CVMP/VICH/839/99December 2000 EMEA 
VICH GL13: Efficacy of anthelmintics:
Specific requirements for ovines
CVMP/VICH/840/99December 2000 EMEA 
VICH GL14: Efficacy of anthelmintics:
Specific requirements for caprine
CVMP/VICH/841/99December 2000 EMEA  
VICH GL15: Efficacy of anthelmintics:
Specific recommendations for equines
CVMP/VICH/833/99July 2002 EMEA 
VICH GL16: Efficacy of anthelmintics:
Specific requirements for porcines
CVMP/VICH/834/99July 2002  EMEA 
VICH GL19: Efficacy of anthelmintics:
Specific recommendations for canines
CVMP/VICH/835/99July 2002 EMEA 
VICH GL20: Efficacy of anthelmintics:
Specific recommendations for feline
CVMP/VICH/545/99July 2002 EMEA  
VICH GL21: Efficacy of anthelmintics:
Specific recommendations for poultry
CVMP/VICH/546/99July 2002 EMEA 

 Ectoparasiticides
NázevČísloDatum platnostiZdrojPoznámka/dokument
Revision: Testing and evaluation
of the efficacy of antiparasitic substances
for the treatment and prevention
of tick and flea infestations'
in dogs and cats
EMEA/CVMP/005/00
-Rev 2
June 2008 EMEA 
Specific Efficacy Requirements
for Ectoparasiticides in cattle
EMEA/CVMP/625/03January 2005 EMEA 
Specific Efficacy Requirements
for Ectoparasiticides in Sheep

EMEA/CVMP/411/01

January 2003 EMEA 
Demonstration of efficacy
of ectoparasiticides
7AE17a Volume 7 September 1994 EMEA  
Summary of Product Characteristics (SPC)
NázevČísloDatum platnostiZdrojPoznámka/dokument
Summary of Product Characteristics
for Pharmaceutical Veterinary Medicinal
Products
DG ENTR/F/2/KK
D(2006)
July 2007Eudralex 
SPC of anthelminticsCVMP/EWP/170208
/2005
February 2008 EMEA 
SPC for antimicrobial productsEMEA/CVMP/SAGAM/
383441/2005
May 2008 EMEA 
Reflection paper on the use
of fluoroquinolones in food producing animals
- Precautions for use in the SPC regarding
prudent use guidance
EMEA/CVMP/416168
/2006-FINAL
November 2006 EMEA 
Availability (minor use/ minor species)
NázevČísloDatum platnostiZdrojPoznámka/dokument
Efficacy and target animal safety data
requirements for veterinary medicinal
products intended for minor uses or minor
species
EMEA/CVMP/EWP/
117899/2004
February 2007 EMEA 
CVMP Guidelines on Data Requirements
for Veterinary Medicinal Products
intended for Minor Uses or Minor Species
EMEA/CVMP/133672
/2005-Rev.1
February 2007 EMEA 
 Multidisciplinary Guidelines

NázevČísloDatum platnostiZdrojPoznámka/dokument
CVMP Advisory Notice to Veterinary Surgeons
regarding the development of fibrosarcoma
at sites of injection of Veterinary Medicinal
Products in cats
EMEA/CVMP/205/03July 2003 EMEA 
Fixed combination productsEMEA/CVMP/83804/05July 2007 EMEA 
Investigation of chiral active substancesEMEA/CVMP/128/95January 1998 EMEA 

Last Updated on Thursday, 02 March 2017 10:19