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zoals aangegeven in de chmp richtlijn met betrekking tot risk management systemen voor geneemsiddelen voor humaan gebruik, dienen aangepaste rmp tegelijk met de volgende psur ingedient te worden.
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).
Last Update: 2012-04-11
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