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en oppdatert risikohåndteringsplan bør legges frem, i henhold til chmp guideline on risk management systems for medicinal products for human use
an updated risk management plan should be provided as per the chmp guideline on risk management system for medicinal products for human use.
i tilfelle tilstander som krever forlenget behandling, bør ansvarlige veterinær gjøre en risk-nytte vurdering på bruken av preparatet.
in case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the product to the risk-benefit assessment by the responsible veterinarian.
i henhold til chmp guideline on risk management systems for medicinal products for human use skal den oppdaterte rmp sendes inn på samme tidspunkt som den neste periodiske sikkerhetsoppdateringsrapporten (periodic safety update report, psur).
as per the chmp guideline on risk management systems for medicinal products for human use, the updated rmp should be submitted at the same time as the next periodic safety update report (psur).