You searched for: vamf (Engelska - Slovenska)

pmf/ vamf emea certificates
potrdila emea za pmf/ vamf

for enquiries concerning vamf certificates
za vprašanja o potrdilih vamf

the vamf system should consist of a two-step assessment:
glavna dokumentacija o antigenu cepiva naj bo sestavljena tako, da omogoča dvodelno oceno:

the emea pmf/ vamf certification process is an assessment of the pmf/ vamf application dossier.
certifikacijski postopek emea za pmf/ vamf je ocenitev dokumentacije za vlogo za pmf/ vamf.

this vamf will allow the pooling of national expertise, and through the coordination by the emea, a single evaluation of the concerned vaccine antigen.
glavna dokumentacija o antigenu cepiva bo omogočila združitev nacionalnega strokovnega znanja in izkušenj, ter s pomočjo koordinacije s strani emea, enotno ovrednotenje zadevnega antigena cepiva.

in order to simplify current procedures for the assessment of veterinary vaccines, both for the granting of a first marketing authorisation and for the subsequent changes to it due to modifications to the manufacturing process and testing of individual antigens involved in combined vaccines, a new system based on the concept of a master file (vaccine antigen master file, vamf) should be introduced for vaccines which involve several antigens.
da se poenostavijo obstoječi postopki za oceno cepiv za uporabo v veterinarski medicini pri izdaji prvega dovoljenja za promet z zdravilom in pri vseh poznejših spremembah dovoljenja zaradi sprememb postopka izdelave in preskušanja posameznih antigenov, vključenih v kombinirana cepiva, je treba za cepiva s številnimi antigeni uvesti nov sistem na podlagi koncepta glavne datoteke o antigenu cepiva (vamf).