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What happens if a marketing authorisation holder does not appoint a graduated plan officer ("Stufenplanbeauftragter")? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

According to section 63a (1) AMG, there is a legal obligation to appoint a graduated plan officer. According to section 63a (3) AMG this person must be notified to the competent local authority and the competent higher federal authority. If this …

Does a marketing authorisation holder, who only holds central marketing authorisations, need to designate and notify a national graduated plan officer ("Stufenplanbeauftragter") in addition to the EU-QPPV? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

A pharmaceutical entrepreneur, who only holds central marketing authorisations, does not need a graduated plan officer. In this case, the EU-QPPV is sufficient, who assumes the tasks of the graduated plan officer to the extent of the obligations …

Is the notification of the graduated plan officer (“Stufenplanbeauftragter”) subject to a fee? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

Yes, the notification is subject to a fee according to the “Besondere Gebührenverordnung BMG” (special fee ordinance; BMGBGebV) (see section 3, fee item 16). To avoid delays, the official billing e-mail address of the party liable to pay the fee must …

Does the notification always apply to all products of a pharmaceutical entrepreneur? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

If nothing else is specified, the reported graduated plan officer (deputy) is responsible for all products of the pharmaceutical entrepreneur. If there are restrictions in the responsibility, this must be indicated in the comment field. It should be …

What is the meaning of "pharmaceutical" and "medical" in the context of responsibility for different graduated plan officers ("Stufenplanbeauftragter")? Date: 05. August 2022 Topics: Pharmakovigilanz Type: FAQ

The tasks of the "medical" graduated plan officer include the tasks specified for the EU-QPPV according to Art. 104 (3) of Directive 2001/83/EC and for the graduated plan officer in section 63a (1) AMG.
For the "pharmaceutical” graduated plan …

Graduated plan officer Date: 05. August 2022 Topics: Pharmakovigilanz Type: Article

The Federal Institute for Drugs and Medical Devices (BfArM) publishes guidance on the new procedure for notifying the graduated plan officer via the PharmNet.Bund portal.

Does the notification also have to be sent separately to the local competent authority (“Länderbehörde”)? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

According to § 63a (3) AMG, notifications must always be sent to both the competent higher federal authority (BfArM and/or PEI) and the competent local authority. The notification to the local authority are currently not possible via the …

Why can't I change the contact details of the pharmaceutical entrepreneur myself? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

These data can only be changed by the employees of the higher federal authorities, as they belong to the master data of the database "Partnerinformationen" (partner information). If you wish to make any changes, please contact:

…

What should be indicated in the comment field? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

In the comment field, assignments for different graduated plan officers of a marketing authorisation holder can be explained (e.g. for different pharmacovigilance systems).

If several graduated plan officers are reported for a pharmaceutical …

Does the notification have to be made by the pharmaceutical entrepreneur or can this also be sent by a service provider appointed by him? Date: 04. August 2022 Topics: Pharmakovigilanz Type: FAQ

Registration or de-registration can only be performed by the pharmaceutical entrepreneur himself or by a person appointed by him. If a service provider is supposed to be responsible for the pharmacovigilance system of a pharmaceutical entrepreneur, …