#2043867
athruithe ar shubstaint ghníomhach i vacsaín shéasúrach, réamh-phaindéime nó phaindéime in aghaidh an fhliú dhaonna;
changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
Filter results
Collections
2 results in 2 documents
#3221535
Anuas ar an iarchur dá ndéantar foráil i bpointe 3.1, le haghaidh gníomhaíochtaí rialála laistigh den chreat a bhaineann le príomh-shainchomhad a chur isteach le haghaidh vacsaín in aghaidh paindéime agus an t-athrú paindéimeach a chur isteach ina dhiaidh sin, beidh feidhm ag laghdú 100 % ar an táille sna cásanna a leanas:
In addition to the deferral provided for in point 3.1, for regulatory activities within the framework of the submission of a core dossier for a pandemic vaccine and the follow-up submission of a pandemic variation, a fee reduction of 100 % shall apply in the following cases: