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et post-marketingovervågningsstudie.
a post marketing surveillance study.
Last Update: 2008-03-04
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indehaveren af markedsføringstilladelsen skal opstille et post- marketingovervågningsstudie, som beskrevet i eu- risikohåndteringsplanens synopsis.
the mah shall set up a post-marketing surveillance study as per the synopsis in the eu-risk management plan.
Last Update: 2012-04-12
Usage Frequency: 3
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medlemslandene skal sammen med indehaveren af markedsføringstilladelsen aftale detaljerne omkring implementering af post- marketingovervågningsstudiet i hvert medlemsland og sikre at studiet er klart inden markedsføring af produktet.
the member states shall agree details of the implementation of the post-marketing surveillance study in each member state with the mah and ensure that it is put in place prior to marketing of the product.
Last Update: 2012-04-12
Usage Frequency: 3
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