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:
regulations.jsp&mid=WC0b01ac058002dd33
| Name of the Guideline | Reference number | Effective from | Note |
| 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 |