An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.
Esitada tuleb kaasajastatud riskijuhtimise plaan vastavalt Euroopa ravimiameti inimesel kasutatavate ravimite komitee (CHMP) juhtnööridele Guideline on Risk Management System for medicinal products for human use.