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Templates and User-Guide for creation of Accessible Package Leaflets

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As pubished an 29.06.2018 the Federal Office for Safety in Health Care (BASG), was obliged in an arbitration process according to § 14 of the Federal…
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eCTD/VNeeS will also be mandatory for purely national lifecycle applications

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According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after…
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EMA EudraVigilance Umstellungsphase

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Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of Eud…
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eCTD/VNeeS will be mandatory for national applications

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In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in…
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