Immunologicals: general
Veterinary
Regulatory and procedural guidance
Research and development
Scientific guidelines
The European Medicines Agency's scientific guidelines on immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products
- Guideline on clinical trials with immunological veterinary medicinal products
- Data requirements for multi-strain dossiers for inactivated veterinary vaccines
- Compliance of authorised equine influenza vaccines with OIE requirements
- Compliance of veterinary vaccines under the centralised procedure with veterinary vaccine monographs of the European Pharmacopoeia
- Use of adjuvanted veterinary vaccines
- Data requirements for for vaccine antigen master files (VAMF)
- Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances
- Data requirements for vaccine platform technology master files (PTMF)
- Data requirements for changes to the strain composition of authorised equine influenza vaccines in line with OIE recommendations
- 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
- Design of studies to evaluate the safety and efficacy of fish vaccines
- DNA vaccines non-amplifiable in eukaryotic cells for veterinary use
- Duration of protection achieved by veterinary vaccines
- Environmental risk assessment for immunological veterinary medicinal products
- EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies
- Live recombinant vector vaccines for veterinary use
- Note on the removal of the target animal batch safetytest (TABST) from European Pharmacopoeia monographs
- Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
- Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats
- Requirements for the production and control of immunological veterinary medicinal products
- Requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)
- The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus
- User safety for immunological veterinary medicinal products
- VICH GL17 Stability testing of biotechnological/biological veterinary medicinal products
- VICH GL25 Biologicals: testing of residual formaldehyde
- VICH GL26 Biologicals: testing of residual moisture
- VICH GL34 Biologicals: testing for the detection of Mycoplasma contamination
- VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
- VICH GL41 Target animal safety: examination of live veterinary vaccines in target animals for absence of reversion to virulence
- VICH GL44 Target animal safety for veterinary live and inactivated vaccines
- VICH GL50 Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use
- VICH GL55 Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use
- VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use
Reflection and position papers
- Assessment of the risk of transmission of animal spongiform encephalopathy agents by master seed materials used in the production of veterinary vaccines
- Batch potency testing of immunological veterinary medicinal product
- Control of the active substance in the finished product for immunological veterinary medicinal products (IVMPs)
- Data requirements for swine influenza vaccines against pandemic (H1N1) 2009 influenza
- Definition of a new biological active substance in terms of active, passive immunity and immunomodulators which then constitute a new active ingredient in the context of part B of the Annex to Council Regulation (EEC) No 2309/93
- Demonstration of a possible impact of maternally derived antibodies on vaccine efficacy in young animals
- Indications for veterinary vaccines
- Methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products
- Replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs)
- Re-establishment of working seeds and working cell banks using TSE compliant materials
- Requirements for vaccines against foot-and-mouth disease
- Use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products
Concept papers
- Guideline on quality aspects of mRNA vaccines for veterinary use
- Guidance on statistical principles for clinical trials for immunological veterinary medicinal products
Public statement
Questions and answers
- Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)
- Questions and answers on the possibility to extrapolate pre-inactivation titres as part of validation of an inactivation process
Procedural advice