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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 …

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.

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