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27 results

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notes on completing the summary evaluation of serious adverse events PDF, 73KB, File is accessible Date: 11. November 2021 Topics: Medical devices Type: Form

Template notes version 4, 2021-06-25

Evaluation docx, 24KB, File does not meet accessibility standards Date: 11. November 2021 Topics: Medical devices Type: Form

SAE / DD summary evaluation
Template version 4, 2021-06-25

MIR-XSDs zip, 29KB, File does not meet accessibility standards Date: 15. October 2019 Topics: Medical devices Type: Form

MIR-XSDs

MIR-XSDs zip, 29KB, File does not meet accessibility standards Date: 15. October 2019 Topics: Medical devices Type: Form

MIR-XSDs

XSDs for direct reporting from manufacturer databases into XML zip, 28KB, File does not meet accessibility standards Date: 28. August 2018 Topics: Medical devices Type: Form

SAE: XSDs for manufacturers, who wish to report directly from their database into an XML file that fulfils the requirements for electronic reporting.

Notification of the Stufenplanbeauftragter rtf, 265KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

According to § 63a subparagraph 3 of the German Medicines Act (AMG), pharmaceutical entrepreneurs are obligated to notify a Stufenplanbeauftragter to the competent authority, the responsible regional authority and, if necessary, also to the …

Notification of a change to the Stufenplanbeauftragter rtf, 299KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

In addition to the obligation to notify a Stufenplanbeauftragter (officer/commissioner of the graduated plan), an alteration or change of the Stufenplanbeauftragter must also be notified. The procedure of notification of a change is identical to the …

Annex 3.1 complication rate vnd.openxmlformats-officedocument.spreadsheetml.sheet, 22KB, File does not meet accessibility standards Date: 13. March 2017 Topics: Medical devices Type: Form

Complication rates within the clinical trial
Template version 2016-09-15

Form Section 29 sub-section 1g AMG rtf, 216KB, File does not meet accessibility standards Date: 21. April 2015 Topics: Licensing Type: Form

Form Section 29 sub-section 1g AMG

Form for submission of PSURs rtf, 324KB, File does not meet accessibility standards Date: 19. August 2013 Type: Form

Form for submission of PSURs