Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol). Dim ond ar ei ffurf wreiddiol y mae’r eitem hon o ddeddfwriaeth ar gael ar hyn o bryd.
6.—(1) The fee for an application for a marketing authorisation for a veterinary medicinal product that contains an active substance which has not previously been included in an authorised veterinary medicinal product in the United Kingdom is £25,500.
(2) This is referred to in this Schedule as an “application for a new active substance”.
(3) If additional applications are submitted at the same time for different strengths of the same active substance in the same dosage form, the fee for each additional strength is £6,390.
(4) If an additional application is submitted at the same time for another dosage form the fee for that additional dosage form is £14,795 and the fee for additional applications for the same dosage form is £ 6,390.
(5) The fee for immunological products submitted at the same time with lesser combination of antigens is £6,390 for each application.
Mae’r holl gynnwys ar gael dan Drwydded Llywodraeth Agored v3.0 ac eithrio ble nodir yn wahanol. Yn ychwanegol mae’r safle hwn â chynnwys sy’n deillio o EUR-Lex, a ailddefnyddiwyd dan delerau Penderfyniad y Comisiwn 2011/833/EU ar ailddefnyddio dogfennau o sefydliadau’r UE. Am ragor o wybodaeth gweler ddatganiad cyhoeddus Swyddfa Gyhoeddiadau’r UE ar ailddefnyddio.
