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emea)
in addition, an updated rmp should be submitted: when new information is received that may impact the current safety specification, pharmacovigilance plan or risk minimisation activities within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached at the request of the emea
leków (emea)
in addition, an updated rmp should be submitted • when new information is received that may impact on the current safety specification, pharmacovigilance plan or risk minimisation activities • within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • at the request of the emea
leków (emea).
the updated rmp should be submitted at the same time as the next periodic safety update report (psur) or at the request of emea.