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Written by Jana Jeřábková
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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 | Source | Note
| 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 |
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Table No 2:Guidelines published by European Medicines Agency EMA in London URL: http://www.emea.europa.eu/ Name | Number | Date
of comming
into effect | Source | Note | 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/550/02 | Říjen 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 | |
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Last Updated on Tuesday, 26 July 2011 12:37 |
Authorisation & Approval 
