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Part IV Pre-Clinical and Clinical Trial |
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Written by Eva Vernerová
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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 Pre-clinical| Název | Číslo | Datum platnosti | Zdroj | Poznámka/dokument | Evaluation of the safety of veterinary
medicinal products for target
animals | 7AE2a Volume 7 | September 1994 | EMEA | | VICH GL43: Target Animal Safety:
Pharmaceuticals | CVMP/VICH/393388/06 | July 2009 | EMEA | | Conduct of bioequivalence studies
for veterinary medicinal products | EMEA/CVMP/016/00
- Rev. 1 | July 2001 | EMEA | Revision: Conduct
of bioequivalence studies
for veterinary medicinal
products | Conduct of pharmacokinetic studies
in target animal species | EMEA/CVMP/133/99 | September 2000 | EMEA | |
Specific Guidelines| Název | Číslo | Datum platnosti | Zdroj | Poznámka/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/237/01 | June 2002 | EMEA | | Efficacy of veterinary medicinal
products for use in farmed
aquatic species | 7AE22a Volume 7 | September 1994 | EMEA | Revision: Efficacy of veterinary
medicinal products for use
in farmed aquatic species | Anticoccidials for the therapy
of coccidiosis in chickens, turkeys
and geese | 7AE15a Volume 7 | May 1993 | EMEA | | Veterinary medicinal products
for zootechnical purposes | 7AE7a Volume 7 | September 1992 | EMEA | | Veterinary medicinal products
for fluid therapy in case of diarrhoea | 7AE14a Volume 7 | September 1992 | EMEA | | Veterinary medicinal products
controlling Varroa jacobsoni and Acarapis
Woodi parasitosis in bees | 7AE16a Volume 7 | March 1992 | EMEA | Revision: Veterinary medicinal
products controlling Varroa
jacobsoni and Acarapis
Woodi parasitosis in bees | | Performance enhancers | 7AE6a Volume 7 | November 1991 | | |
Antimicrobials| Název | Číslo | Datum platnosti | Zdroj | Poznámka/dokument | | SPC for antimicrobial products | EMEA/CVMP/SAGAM/
383441/2005 | May 2008 | EMEA | | Demonstration of efficacy
for veterinary medicinal products
containing antimicrobial substances | EMEA/CVMP/627/01 | June 2003 | EMEA | |
Product for intramammary use| Název | Číslo | Datum platnosti | Zdroj | Poznámka/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| Název | Číslo | Datum platnosti | Zdroj | Poznámka/dokument | | SPC of anthelmintics | CVMP/EWP/170208
/2005 | February 2008 | EMEA | | VICH GL7: Efficacy of anthelmintics:
General requirements | CVMP/VICH/832/99 | December 2000 | EMEA | | VICH GL12: Efficacy of anthelmintics:
Specific recommendations for bovines | CVMP/VICH/839/99 | December 2000 | EMEA | | VICH GL13: Efficacy of anthelmintics:
Specific requirements for ovines | CVMP/VICH/840/99 | December 2000 | EMEA | | VICH GL14: Efficacy of anthelmintics:
Specific requirements for caprine | CVMP/VICH/841/99 | December 2000 | EMEA | | VICH GL15: Efficacy of anthelmintics:
Specific recommendations for equines | CVMP/VICH/833/99 | July 2002 | EMEA | | VICH GL16: Efficacy of anthelmintics:
Specific requirements for porcines | CVMP/VICH/834/99 | July 2002 | EMEA | | VICH GL19: Efficacy of anthelmintics:
Specific recommendations for canines | CVMP/VICH/835/99 | July 2002 | EMEA | | VICH GL20: Efficacy of anthelmintics:
Specific recommendations for feline | CVMP/VICH/545/99 | July 2002 | EMEA | | VICH GL21: Efficacy of anthelmintics:
Specific recommendations for poultry | CVMP/VICH/546/99 | July 2002 | EMEA | |
Ectoparasiticides| Název | Číslo | Datum platnosti | Zdroj | Poznámka/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/625/03 | January 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)| Název | Číslo | Datum platnosti | Zdroj | Poznámka/dokument | Summary of Product Characteristics
for Pharmaceutical Veterinary Medicinal
Products | DG ENTR/F/2/KK
D(2006) | July 2007 | Eudralex | | | SPC of anthelmintics | CVMP/EWP/170208
/2005 | February 2008 | EMEA | | | SPC for antimicrobial products | EMEA/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)| Název | Číslo | Datum platnosti | Zdroj | Poznámka/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| Název | Číslo | Datum platnosti | Zdroj | Poznámka/dokument | CVMP Advisory Notice to Veterinary Surgeons
regarding the development of fibrosarcoma
at sites of injection of Veterinary Medicinal
Products in cats | EMEA/CVMP/205/03 | July 2003 | EMEA | | | Fixed combination products | EMEA/CVMP/83804/05 | July 2007 | EMEA | | | Investigation of chiral active substances | EMEA/CVMP/128/95 | January 1998 | EMEA | |
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Last Updated on Thursday, 02 March 2017 10:19 |
Authorisation & Approval