Zwei Jahre lang war das EU-Pharmapaket, bestehend aus der EU-Pharmaverordnung (EU Pharma Regulation) und der gleichnamigen Richtlinie (Directive), in Arbeit. Nach dem dritten Trilog zwischen Kommission, EU-Parlament und Rat während einer Nachtsitzung von Mittwoch auf Donnerstag konnten die drei Institutionen endlich den Vollzug melden: Alle strittigen Punkte sind beseitigt. Besonders hart umkämpft waren die Fristen für den Unterlagenschutz, die sogenannte Bolar-Klausel, die Förderung von Antibiotika-Neuentwicklungen sowie die Berichterstattungspflichten für Arzneimittelengpässe.
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Pauschalmodell soll Absatzreize senken
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Zu hohe bürokratische Hürden?
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