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Graduated plan officer (Stufenplanbeauftragter) in Germany
VigiServe Admin@admin
#1 · December 15, 2020, 2:36 PM
Quote from VigiServe Admin on December 15, 2020, 2:36 PMRegarding the qualifications of the "Stufenplanbeauftragter", the requirements were revised in the revision of the AMG in July 2009 to be equal to those of the EU QPPV so a EU QPPV could also be a "Stufenplanbeauftragter". In addition to the "Stufenplanbeauftragter" a deputy with similar qualifications is required.
There is no requirement as such in the AMG that the "Stufenplanbeauftragter" has to speak German or be a resident of Germany. It is only written that the "Stufenplanbeauftragter" has to be resident in a Member State of the European Union (AMG section 63a). However, as the "Stufenplanbeauftragter" has to communicate a lot with the BfArM and the competent authorities in the federal states (Landesbehoerden) and that communication is almost exclusively in German, it will be almost impossible for the Stufenplanbeauftragter to fulfil his role without being able to speak German.
Which legal obligations does the “Stufenplanbeauftragter” have?
The specific legal obligations of the "Stufenplanbeauftragter" are defined in the AMG and in the regulation “Arzneimittel- und Wirkstoffherstellverordnung .- AMWHV”. They are similar to those of the EU QPPV but not identical (e.g. quality complaints in the AMWHV). For details, please refer to the current Medicinal Products Act and regulation.
Does the “Stufenplanbeauftragter” have to be notified to the BfArM?
Yes. The notification of the "Stufenplanbeauftragter" has to occur in writing to the BfArM and the responsible competent authority in the federal state (Landesbehoerde). The notification should include name, contact details, and 24-h availability as well as name and contact details of the deputy.
The BfArM has recently also created the possibility for electronic notification of the "Stufenplanbeauftragter".
Does Germany require the nomination of a local pharmacovigilance responsible person?
Germany requires the nomination of such an individual. This person is called the "Stufenplanbeauftragter" (Officer of the graduate plan) and is defined in section 63a of the German Drug Law (AMG)
Which qualifications does the “Stufenplanbeauftragter” need?
Regarding the qualifications of the "Stufenplanbeauftragter", the requirements were revised in the revision of the AMG in July 2009 to be equal to those of the EU QPPV so a EU QPPV could also be a "Stufenplanbeauftragter". In addition to the "Stufenplanbeauftragter" a deputy with similar qualifications is required.
Does the “Stufenplanbeauftragter” have to reside in Germany?
There is no requirement as such in the AMG that the "Stufenplanbeauftragter" has to speak German or be a resident of Germany. It is only written that the "Stufenplanbeauftragter" has to be resident in a Member State of the European Union (AMG section 63a). However, as the "Stufenplanbeauftragter" has to communicate a lot with the BfArM and the competent authorities in the federal states (Landesbehoerden) and that communication is almost exclusively in German, it will be almost impossible for the Stufenplanbeauftragter to fulfil his role without being able to speak German.
Which legal obligations does the “Stufenplanbeauftragter” have?
The specific legal obligations of the "Stufenplanbeauftragter" are defined in the AMG and in the regulation “Arzneimittel- und Wirkstoffherstellverordnung .- AMWHV”. They are similar to those of the EU QPPV but not identical (e.g. quality complaints in the AMWHV). For details, please refer to the current Medicinal Products Act and regulation.
Does the “Stufenplanbeauftragter” have to be notified to the BfArM?
Yes. The notification of the "Stufenplanbeauftragter" has to occur in writing to the BfArM and the responsible competent authority in the federal state (Landesbehoerde). The notification should include name, contact details, and 24-h availability as well as name and contact details of the deputy.
The BfArM has recently also created the possibility for electronic notification of the "Stufenplanbeauftragter".
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#2 · March 4, 2021, 2:34 PM
Quote from VigiServe Admin on March 4, 2021, 2:34 PMNotification of the Graduated Plan officer
According to Section 63a (3) of the Medicines Act (AMG), pharmaceutical entrepreneurs are obliged to report a step-by-step plan officer to the higher federal authority at the responsible state authority and, if necessary, also to the Paul Ehrlich Institute. The report can preferably be made electronically to pv-inspektiven@bfarm.de or by post to Department 75 of the Federal Institute for Drugs and Medical Devices. The notification of the phased plan officer must contain the name of the pharmaceutical company and the full contact details of the person notified (name, address, telephone number / 24/7 availability). Optionally, a résumé can be submitted as a reference for professional suitability.
If your report is submitted via a service provider or the task of the graduated plan officer is performed by a service provider, you need to indicate this in your report.
Attachment: MAH form for Notifying the graduated plan officer.
Notification of the Graduated Plan officer
According to Section 63a (3) of the Medicines Act (AMG), pharmaceutical entrepreneurs are obliged to report a step-by-step plan officer to the higher federal authority at the responsible state authority and, if necessary, also to the Paul Ehrlich Institute. The report can preferably be made electronically to pv-inspektiven@bfarm.de or by post to Department 75 of the Federal Institute for Drugs and Medical Devices. The notification of the phased plan officer must contain the name of the pharmaceutical company and the full contact details of the person notified (name, address, telephone number / 24/7 availability). Optionally, a résumé can be submitted as a reference for professional suitability.
If your report is submitted via a service provider or the task of the graduated plan officer is performed by a service provider, you need to indicate this in your report.
Attachment: MAH form for Notifying the graduated plan officer.
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#3 · March 4, 2021, 2:37 PM
Quote from VigiServe Admin on March 4, 2021, 2:37 PMDo all companies holding Marketing Authorization in Germany, need to appoint a Graduated Plan officer?
Yes. However, the MAH can decide to appoint the QPPV/Back-up based in EU/EEA as the Graduated Plan Officer.
Do all companies holding Marketing Authorization in Germany, need to appoint a Graduated Plan officer?
Yes. However, the MAH can decide to appoint the QPPV/Back-up based in EU/EEA as the Graduated Plan Officer.
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Does Germany require the nomination of a local pharmacovigilance responsible person?
Germany requires the nomination of such an individual. This person is called the "Stufenplanbeauftragter" (Officer of the graduate plan) and is defined in section 63a of the German Drug Law (AMG)