BfArM - Federal Institute for Drugs and Medical Devices

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German SAE Report Form PDF, 1MB, File does not meet accessibility standards Date: 28. May 2025 Topics: Medical devices Type: Form

Report form for reporting of serious adverse events (SAE) in clinical trials or performance studies for use by sponsors according to § 3 (5) of the Ordinance on Medical Devices Vigilance

PDF-Form (use of Adobe Acrobat 9.X recommended)

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.

Notes on XSD use PDF, 99KB, File is accessible

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

Form for submission of PSURs rtf, 312KB, File does not meet accessibility standards Date: 13. June 2013 Type: Form

Form for submission of PSURs

Form PDF, 1MB, File does not meet accessibility standards Date: 18. December 2012 Type: Form

FSCA Report Form (Initial, Final and Follow-up) according to § 3 (1) of the Ordinance on Medical Devices Vigilance by the Manufacturer, Authorised Representative or Importer (or Distributor)

PDF-Form (use of Adobe Acrobat 9.X recommended, not …

XSDs for direct reporting from manufacturer databases into XML zip, 8KB, File does not meet accessibility standards Date: 25. September 2012 Topics: Medical devices Type: Form

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

Notes on XSD use PDF, 99KB, File is accessible

Declaration for the adoption of BfArM core texts for PIL and SPC in Notifications of national Variation pursuant to Section 29 AMG (Tick which applies) doc, 42KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

(available in German only)

Example 1 PDF, 25KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

German - English

Example 2 PDF, 24KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

German - English

Form for variation notification
new set of forms doc, 48KB, File does not meet accessibility standards Date: 04. January 2011 Topics: Licensing Type: Form

(available in German only)

Reporting form for communication of quality defects, batch recalls, and counterfeit drugs rtf, 38KB, File does not meet accessibility standards Date: 28. September 2010 Topics: Pharmakovigilanz Type: Form

Click here for the reporting form with which pharmaceutical companies can communicate quality defects, batch recalls and counterfeit drugs to the competent authority.

Form for prolongation of the PSUR submission interval rtf, 206KB, File does not meet accessibility standards Date: 24. August 2010 Type: Form

Form for prolongation of the PSUR submission interval

Reporting form for adverse drug reactions (ADR) PDF, 363KB, File does not meet accessibility standards Date: 23. February 2010 Topics: Pharmakovigilanz Type: Form

If you have observed an adverse drug reaction that you wish to report, please use the form provided here in the table. ADR s can also be reported online. Since the scientific assessment of reported events requires specialised medical information, the …

List of Change Items Version 1.6 PDF, 77KB, File does not meet accessibility standards Date: 11. March 2009 Topics: Licensing Type: Form

German - English

Annex 2
declaration on adaptation to BfArM core texts of package leaflet and SPC rtf, 40KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(available in German only)

Annex 1
submission on pharmaceutical quality for licences according to Section 105 in connection with Section 109a AMG rtf, 32KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(available in German only)

Table of contents (according to Common Technical Document - CTD) rtf, 49KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(available in German only)

Set of forms
concerning the application for renewal of a licence/registration according to Sections 31, 39 AMG rtf, 23KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(available in German only)

References
to the declaration concerning the pharmaceutical quality rtf, 12KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Form

(available in German only)

Cover letter
concerning the renewal application rtf, 167KB, File does not meet accessibility standards Date: 07. March 2005 Topics: Licensing Type: Form

(available in German only)