検索ワード: turetojas (リトアニア語 - 英語)

registravimo liudijimo turetojas
7 marketing authorisation holder

rinkodaros teises turetojas ir gamintojas
marketing authorisation holder and manufacturer

konkretus isipareigojimai, kuriuos turi vykdyti registravimo liudijimo turetojas
specific obligations to be fulfilled by the marketing authorisation holder

[ irasys registravimo liudijimo turetojas po preparato registracijos. ]
[ item to be completed by the marketing authorisation holder once the marketing authorisation has been granted. ]

[ irasys registravimo liudijimo turetojas po preparato registracijos arba perregistracijos. ]
[ item to be completed by the marketing authorisation holder once the marketing authorisation has been granted or renewed. ]

biologines veikliosios medŽiagos gamintojas ir gamybos licencijos turetojas, atsakingas uŽ serijos iŠleidima
manufacturer of the biological active substance and manufacturing authorisation holder responsible for batch release

parlamento patalpose leidimo turetojas privalo visuomet ne5ioti leidirn4 taip, kad jis bltq ai3kiaimatomas.
pass-holders shall at all timeswear their passvisibly on all parliament premises.

registravimo liudijimo turetojas taip pat isipareigoja testi dialoga su emea/ chmp del tyrimu rengimo.
furthermore, the mah commits to continue dialogue with emea/ chmp with regard to study design

chmp prasymu registravimo liudijimo turetojas sutiko pateikti tolesnes tyrimo priemones, kurios nurodytos zemiau:
as requested by the chmp, the mah agreed to submit the follow-up measures as listed below:

registravimo liudijimo turetojas leo pharma a/ s, industriparken 55, dk- 2750 ballerup, danija..
marketing authorisation holder leo pharma a/s, industriparken 55, dk-2750 ballerup, denmark.

aprasymas registravimo liudijimo turetojas isipareigoja atlikti bendra sirdies ir kraujagysliu sistemos tyrima ir patvirtinti ilgalaiki celekoksibo sauguma sirdies ir kraujagysliu sistemai.
the mah commits to performing a global cv study to confirm long term cv safety of celecoxib.

c) registravimo liudijimo turetojas užtikrina, kad gydytojams pateiktoje medžiagoje pakaktu informacijos apie poregistracines priežiuros ir imunologines priežiuros programas.
c) the mah will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.

registravimo liudijimo turetojas per nustatyta laika turi ivykdyti toliau nurodyta tyrimu programa, kurios rezultatais remiantis kasmet bus nustatomas preparato naudos ir žalos santykis.
the marketing authorisation holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.

gamybos licencijos turetojas, atsakingas už serijos išleidima leo pharma a/ s, industriparken 55, dk- 2750 ballerup, danija..
manufacturer authorisation holder responsible for batch release leo pharma a/s, industriparken 55, dk-2750 ballerup, denmark.

b) prieš pateikdamas vaista i bet kurios es valstybes nares rinka, registravimo liudijimo turetojas sudarys imunines priežiuros programa ir gydytojams pateiks antikunu prieš atryn nustatymo priemones.
b) prior to launch in any eu member state, the mah will set up an immunosurveillance programme and provide antibody testing for anti-atryn antibodies to physicians.

leidimas yra plastikine kortele su turetojo nuotrauka, kurioje yta pa ll t m e ta turetojopavarde ir vardas bei irnones, organizacijos ar asmens, kuriems leidimo turetojas dirba' pavadinimas.
the passshall consist of a plastic card,beming a photographof the holder, indicating the holder's surname and forenamesand the name of the firm, organisation or person for whom the holderworks. works.

jei registravimo liudijimo turetojas neturi issamiu tyrimu ataskaitu, jis sutinka vietoj tyrimu ataskaitos (-u) pateikti leidinius (rankrascius) .
where full study reports are not available to the mah, it agrees to provide publications/manuscripts in lieu of the study report(s) .

32 registravimo liudijimo turetojo tolesnio tyrimo priemones
30 follow-up measures of the marketing authorisation holder