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Home Authorisation & Approval Marketing authorisation of VMPs Immunologicals guidelines
Immunological guidelines PDF Print E-mail

In compliance with the Act No 378/2007 on Pharmaceuticals and its implementing Regulation No 228/2008 on Marketing authorisation USKVBL requests for ensuring quality, safety and efficacy of Immunological veterinary medicinal products (IVMP) observance rules that are detailed described in some legal regulations concerning the marketing authorisation area.

General guidelines (See Czech version)

  • USKVBL/REG-3/2009 Rev.2 - Templates for preparation of SPC, labelling and package leaflet
  • USKVBL/REG - 1/2010 Rev.1 - Detailed information on the draft texts for small single-dose immediate packaging units of IVMP in a language other than Czech

Guidelines for particular parts of dossier

For the preparation of the quality, safety and efficacy part of the dossier for IVMP for the purposes of marketing authorisation applications, the requirements of European Pharmacopoeia published by EDQM together with recommendations of guidelines published on the European Medicines Agency (EMA) web-site should be taken into consideration (see the link below).

In addition to the overview of EMA guidelines below, the EMA also publishes and updates the list of reflection and position papers on the clarification of requirements in different areas of IVLP assessment.

 

Overview of EMA Guidelines for Immunological Veterinary Medicinal Products:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000194.jsp&murl=menus/regulations/

regulations.jsp&mid=WC0b01ac058002dd33

 

Name of the GuidelineReference numberEffective fromNote
Guideline on requirements for the production and control of immunological veterinary medicinal products EMA/CVMP/IWP/206555/2010-Rev.1 01/05/2017 NEW!
Environmental risk assessment for immunological veterinary medicinal products EMA/CVMP/074/95 01/02/1997
Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with OIE recommendations EMA/CVMP/IWP/97961/2013 07/05/2015
Use of adjuvanted veterinary vaccines EMA/CVMP/IWP/043/97 01/12/1998
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use EMA/CVMP/IWP/07/98 01/01/2001
Duration of protection achieved by veterinary vaccines EMA/CVMP/682/99 01/05/2001
EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies EMA/CVMP/552/02 17/06/2002
Field trials with veterinary vaccines EMA/CVMP/852/99 01/12/2001
Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products EMA/CVMP/743/00 Rev.2 01/01/2006
Requirements for the production and control of allergen products for use in animals 7BIm11a 01/09/1994
Live recombinant vector vaccines for veterinary use EMA/CVMP/004/04 08/06/2005
User safety for immunological veterinary medicinal products EMA/CVMP/IWP/54533/2006 01/11/2007
Requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza EMA/CVMP/IWP/222624/2006 01/11/2007
Requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue EMA/CVMP/IWP/220193/2008 01/05/2009
Data requirements for immunological veterinary medicinal products intended for minor use or minor species EMEA/CVMP/IWP/123243/2006 Rev. 3 01/11/2017 NEW!
Requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) EMEA/CVMP/IWP/594618/2010 01/02/2014
The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus EMA/CVMP/IWP/205351/2006 Rev. 1 01/03/2016
Data requirements for multi-strain dossiers for Inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot-and-mouth disease (FMD) EMA/CVMP/IWP/105506/2007 01/07/2010
Data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPS) by new master seed of the same origin EMA/CVMP/IWP/105504/07 01/02/2010
Design of studies to evaluate the safety and efficacy of fish vaccines EMA/CVMP/IWP/314550/2010 01/05/2012
Data requirements to support in-use stability claims for veterinary vaccines EMEA/CVMP/IWP/250147/2008 01/10/2010
VICH GL17 Stability testing of biotechnological/biological veterinary medicinal products EMA/CVMP/VICH/501/99 01/06/2001
VICH GL25 Biologicals: testing of residual formaldehyde EMA/CVMP/VICH/095/01 01/05/2003
VICH GL26 Biologicals: testing of residual moisture EMA/CVMP/VICH/096/01 01/05/2003
VICH GL34 Biologicals: testing for the detection of Mycoplasma contamination EMA/CVMP/VICH/463/2002 28/02/2014
VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal productsy EMEA/CVMP/VICH/811/04 01/11/2006
VICH GL41 Target animal safety: examination of live veterinary vaccines in target animals for absence of reversion to virulence EMA/CVMP/VICH/1052/2004 01/07/2008
VICH GL44 Target animal safety for veterinary live and inactivated vaccines EMA/CVMP/VICH/359665/2005 01/07/2009
VICH GL50 Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use EMA/CVMP/VICH/582610/2009 01/05/2018 new version Revision 1 - coming into effect 01/05/2018
VICH GL55 Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use EMA/CVMP/VICH/313610/2013 01/05/2018 new version Revision 1 - coming into effect 01/05/2018

 
Last Updated on Friday, 13 April 2018 12:00
 


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