Immunologicals: guidelines - General

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

• 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
• Live recombinant vector vaccines for veterinary use
• Quality aspects of mRNA vaccines for veterinary use
• 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)
• Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products
• 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
• 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
• Use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products

Concept papers

• Guidance on statistical principles for clinical trials for immunological veterinary medicinal products

Public statement

• Routes of administration of vaccines to poultry

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

• Procedural advice for vaccine platform technology master file (vPTMF) certification
• Procedural advice for veterinary vaccine antigen master file (VAMF) certification

Archive

Archive - obsolete guidance documents

• EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies
• Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
• ​​​​Requirements for vaccines against foot-and-mouth disease
• Note on the removal of the target animal batch safetytest (TABST) from European Pharmacopoeia monographs
• 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