검색어: farmakovigilanza (몰타어 - 영어)

sistema ta ’ farmakovigilanza
• other conditions

sostenn ta ’ l- organizzazzjoni farmakovigilanza u -
regulatory affairs and organisational support pharmacovigilance and post -

prattika tajba tal- laboratorju prattika klinika tajba (inkluż farmakovigilanza) gmp (inkluż pmf)
good laboratory practice good clinical practice (including pharmacovigilance) gmp (including pmf)

l- mah jrid jizgura li s- sistema ta 'farmakovigilanza tkun implimentata u tkun tahdem qabel ma l- prodott jibda jinbiegh.
the mah must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.

l- mah huwa obbligat li jwettaq l- istudji u attivitajiet ta 'farmakovigilanza addizzjonali deskritti fil- pjan tal- farmakovigilanza.
the mah commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan.

ah għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta’ farmakovigilanza dettaljati fl- rmp maqbul ippreżentat fil-modulu 1.8.2. tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-rmp.
the mah shall perform the required pharmacovigilance activities and interventions detailed in the agreed rmp presented in module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the rmp.