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 Paul-Ehrlich-Institut. The notification can preferably be made electronically to pv-inspektionen@bfarm.de or by postal mail to Unit 75 of the Federal Institute for Drugs and Medical Devices. The notification of the Stufenplanbeauftragter must include the name of the pharmaceutical entrepreneur as well as complete contact details of the person notified (name, address, telephone number/24h availability). Optionally, a curriculum vitae can be submitted as a reference for professional qualification. If your notification is submitted via a service provider or if the role of the Stufenplanbeauftragter is performed by a service provider, please indicate this in your notification. This form is only available in German.

Notification of the Stufenplanbeauftragter rtf, 265KB, File does not meet accessibility standards