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Graduated plan officer

Graduated plan officer (Stufenplanbeauftragter) - information and notification via the portal

According to Section 63a of the German Medicines Act (AMG), a pharmaceutical entrepreneur who places finished medicinal products on the market which are medicinal products within the meaning of Section 2 (1) or subsection (2) No. 1 AMG must appoint a qualified person resident in a Member State of the European Union, who has the necessary expertise and the reliability required for exercising his/her function (graduated plan officer). In addition to marketing authorisation holders, this also applies to co-distributors and users of standard marketing authorisations, as they are also pharmaceutical entrepreneurs according to Section 4 (18) AMG and place medicinal products on the market under their  own name.

Pursuant to Section 63 a AMG, a graduated plan officer (which is equivalent to the EU-QPPV) for national marketing authorisations and marketing authorisations from DCP or MRP procedures must be notified to the competent authority (Landesbehörde) and to the competent higher federal authority (Federal Institute for Drugs and Medical Devices and/or the Paul-Ehrlich-Institute, if applicable) for the area of application of the AMG.

The tasks of the graduated plan officer are defined in the German Medicines Act and in the Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV). Due to the specifications in the AMWHV, the tasks of the graduated plan officer include additional obligations compared to the EU-QPPV (e.g. systematic recording of complaints as well as informing the competent local authority of any defect that could lead to a recall or unusual restriction of distribution).

The graduated plan officer must be sufficiently knowledgeable, a specific proof of expertise is not (any longer) required. The person must have sufficient professional qualification to ensure compliance with the relevant regulations, in particular the company pharmacovigilance system.

This qualification can be acquired through professional training and practical experience. The assessment of the professional qualification is carried out on a case-by-case basis and should be based on the product portfolio of the pharmaceutical entrepreneur and the assessment of potential medicinal product risks associated with it (Section 19 (1) AMWHV). Further details on this are to be agreed with the competent local authorities (Landesbehörde).

The German Medicines Act does not specify any language. However, since communication with the authorities is predominantly in German, the graduated plan officer must have access to an appropriately qualified person 24 hours a day if he/she is not himself/herself a German speaker.

The graduated plan officer can be EU-QPPV at the same time, an additional notification of the graduated plan officer is required.

The notification of the graduated plan officer according to § 63 a (3) AMG is done via the PharmNet.Bund portal "Notification of the Graduated Plan Officer". Further information on registration for participation in this application can be found here:

Meldung des Stufenplanbeauftragten
 

The notification portal is used for the notification of graduated plan officers, deputies, change notifications of persons or contact data, as well as for the de-registration of the appointed persons and implements the requirements of the Online Access Act (OZG).

All statements on the graduated plan officer or the person entrusted with the tasks of the graduated plan officer within the meaning of the AMWHV are also valid for the deputies.

If you have any questions, please use the contact form in the PharmNet.Bund portal.

Notifications of the information officer according to § 74a (3) AMG are to be sent exclusively to the competent local authorities (Landesbehörden).

FAQ

Does the notification have to be made by the pharmaceutical entrepreneur or can this also be sent by a service provider appointed by him?

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, then the pharmaceutical entrepreneur should register himself as the main user in the “Registrierung und Benutzerverwaltung” (registration and user administration; RuBen) and create the service provider as a sub-user. In doing so, the RuBen main user (i.e. the pharmaceutical entrepreneur) can restrict the authorisations for the sub-user (i.e. the service provider) to the role "pharmacovigilance". This account then authorises the use of the application "Meldung des Stufenplanbeauftragten" by a service provider.
Please note that changes may only be made by authorised persons. There are no restrictions on the entry options.

Within what period of time must a registration or de-registration take place?

According to legislation, a notification must be made to the competent authority prior to the appointment of the graduated plan officer. In the event of an unforeseen change of the graduated plan officer, the notification must be made without delay. The date of the notification may not be more than one week after the change of the graduated plan officer and not more than 3 months before the introduction (start of service) of graduated plan officer.

Is it possible to make modifications on my notification?

The pharmaceutical entrepreneur or the appointed service provider can initially save the notification and then continue to edit it. If the notification has been sent and has the status "completed", changes can only be made via a change notification.

More FAQs on the topic