National Authorisation Procedures - Forms
Please notice that on 01 June 2018 the amendment to the " Bekanntmachung zur Angleichung der Bearbeitung rein nationaler Anträge auf Zulassung oder Registrierung von Arzneimitteln an das dezentralisierte Zulassungsverfahren" (of 18 January 2016) was published. In replying to the deficiencies in the evaluation report, the applicant does not need to fill in the "Zulassungsmaske".
Content currently only available in German