The replacement or the addition of a new antigen or a new strain in the case of already authorised immunological veterinary medicinal products against, for example, avian influenza, bluetongue, foot and mouth disease or equine influenza should not be considered as adding a new active substance.
Maidir le haintigin nua nó tréithchineál nua a athsholáthar nó a chur isteach i gcás táirgí íocshláinte tréidliachta imdhíoneolaíochta i gcoinne, mar shampla, fhliú na n-éan, galar gormtheanga, an ghalair crúb is béil, nó fliú eachaí, níor cheart é a mheas mar shubstaint ghníomhach nua a chur leis an táirge.