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Immunological guidelines PDF Print E-mail
Written by Jana Jeřábková   

Without prejudice to specific requirements laid down by Community legislation for the control and eradication of specific infectious animal diseases, the requirements done in Directive 2001/82/EC shall apply to immunological veterinary medicinal products, except when the products are intended for use in some species or with specific indications as defined in Title III of Annex I and in relevant guidelines.

 

Table No 1:

Guidelines published by European Commision, Brussel

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex

Name Number
Date
of comming
into effect
SourceNote
Guideline on preparation of Summary
of the Product Characteristics
- SPC - Immunologicals
 6C  Eudralex 
Environmental risk assessment
for immunological veterinary
medicinal products
 7A  Eudralex 
General requirements for the production
and control of live mammalian bacterial
and viral vaccines for veterinary use
 7B  Eudralex 
General requirements for the production
and control of inactivated mammalian bacterial
and viral vaccines for veterinary use
 7B  Eudralex 
Specific requirements for the production
and control of avian live and inactivated viral
and bacterial vaccines for veterinary use
 7B  Eudralex
Specific requirements for the production
and control of bovine live and inactivated
viral and bacterial vaccines
 7B  Eudralex 
Specific requirements for the production
and control of pig live and inactivated
viral and bacterial vaccines
 7B  Eudralex 
Specific requirements for production and
control of ovine and caprine live and inactivated
viral and bacterial vaccines
 7B  Eudralex 
Specific requirements for production
and control of equine live and inactivated
viral and bacterial vaccines
 7B  Eudralex 
Specific requirements for production
and control live and inactivated vaccines
intended for fish
 7B  Eudralex 
Specific requirements for production
and control of live and inactivated
vaccines for cats and dogs
 7B  Eudralex 

Table of extraneous agents to be
tested for in relation to the general
and species-specific  guidelines on production
and control of mammalian veterinary vaccines

 7B  Eudralex 
Table No 2:

Guidelines published by European Medicines Agency EMA in London

URL: http://www.emea.europa.eu/

Name

NumberDate
of comming
into effect
SourceNote
Environmental risk assessment
for immunological
veterinary medicinal products
 EMEA/CVMP/074/95  EMEA 
Harmonisation of requirements
for equine influenza vaccines: specific requirements
for substitution or addition of a strain or strains
 EMEA/CVMP/112/98  EMEA 
Use of adjuvanted veterinary vaccines CVMP/IWP/043/97  EMEA 
Requirements for combined veterinary vaccines CVMP/IWP/52/97  EMEA 
DNA vaccines non-amplifiable in eukaryotic cells
for veterinary use
 CVMP/IWP/07/98  EMEA 
Duration of protection achieved
by veterinary vaccines
 EMEA/CVMP/682/99  EMEA 

VICH GL17: Stability testing of biotechnological/biological
veterinary medicinal products

 CVMP /VICH /501/99   EMEA 
Field trials with veterinary vaccines EMEA/CVMP/852/99  EMEA 

Requirements and controls applied to bovine serum
used n the production of immunological veterinary
medicinal products

 EMEA/CVMP/743/00  EMEA 
Requirements for concurrent administration of Immunological Veterinary Medicinal Products EMEA/CVMP/550/02Říjen 2003 EMEA 
Requirements for vaccines against Foot-and-Mouth Disease EMEA/CVMP/775/02  EMEA 
Data requirements for removing the Target Animal
Batch Safety Test for Immunological Veterinary
Medicinal Products in the EU
 EMEA/CVMP/865/03  EMEA 
Live recombinant vector vaccines
for veterinary use
 EMEA/CVMP/004/04  EMEA 
Note for guidance on minimising the risk
of transmiting animal spongiform encephalopathy
agents via human and veterinary medicinal products
 EMEA/CVMP/410/01 Rev.3  EMEA 
User safety for immunological
veterinary medicinal products
 EMEA/CVMP/IWP/
54533/2006
 1.11.2007 EMEA 
Requirements for an authorisation under
exceptional circumstances for vaccines for
use in birds against avian influenza
 EMEA/CVMP/IWP/
222624/2006
 1.11.2007 EMEA 
Requirements for an authorisation
under exceptional circumstances
for vaccines for emergency use against bluetongue
 EMEA/CVMP/IWP/
220193/2008
 květen 2009 EMEA 
Data requirements for immunological
veterinary medicinal products intended
for minor use or minor species
 EMEA/CVMP/IWP/
123243/2008
 1.2.2008 EMEA 
Last Updated on Thursday, 02 March 2017 10:20