All variation categories concerning changes to veterinary products were removed from the Variations Guidelines current version C/2025/5045.
C.II.1 Variations concerning a change to or addition of a non-food producing target species.
C.II.2 Deletion of a food producing or non-food producing target species.
C.II.3 Changes to the withdrawal period for a veterinary medicinal product
C.II.7 Introduction of a new Pharmacovigilance system
C.II.8 Change in the frequency and/or date of submission of periodic safety update reports (PSUR)
#cii1
| C.II.1 Variations concerning a change to or addition of a non-food producing target species. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#cii2
| C.II.2 Deletion of a food producing or non-food producing target species. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) Deletion as a result of a safety issue | II | ||
| b) Deletion not resulting from a safety issue | 1, 2 | IB | |
| Documentation | |||
| 1. Justification for the deletion of the target species | |||
| 2. Revised product information | |||
#cii3
| C.II.3 Changes to the withdrawal period for a veterinary medicinal product | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#cii4
| C.II.4 Variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#cii5
| C.II.5 Variations concerning the replacement of a strain for a veterinary vaccine against equine influenza. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| II |
#cii6
| C.II.6 Changes to the labelling or the package leaflet which are not connected with the summary of product characteristics. | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) Administrative information concerning the holder’s representative | 1 | IAIN | |
| b) Other changes | 1 | IB | |
| Documentation | |||
| 1. Revised product information. | |||
#cii7
| C.II.7 Introduction of a new Pharmacovigilance system | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) Which has not been assessed by the relevant national competent authority/EMA for another product of the same MAH | II | ||
| b) Which has been assessed by the relevant national competent authority/EMA for another product of the same MAH(*) | 1, 2 | IB | |
| Documentation | |||
| 1. The new Detailed Description of the Pharmacovigilance System (DDPS) | |||
| 2. Reference to the application/procedure and product in which the DDPS was assessed previously | |||
| (*) Note: This variation covers the situation where the applicability of an already assessed Pharmacovigilance System will have to be assessed for the new MAs concerned (e.g. at time of transfer of MA) | |||
#cii8
| C.II.8 Change in the frequency and/or date of submission of periodic safety update reports (PSUR) | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1 | IAIN | |
| Conditions | |||
| 1. The change in the frequency and/or date of submission of the PSUR has been agreed by the competent authority | |||
| Documentation | |||
| 1. Attached to the cover letter of the variation application: The relevant decision of the competent authority | |||