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.

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.

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.

The system automatically sends confirmations of receipt and information on the status of a notification by e-mail. If a graduated plan officer has been de-registered and a new one has not yet been notified, the system sends reminder e-mails.

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 entrepreneur (section 63a (3) AMG), the areas of responsibility must be clearly demarcated from one another (section 63a (1) sentence 6 AMG).

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:

Partnerinformationen@bfarm.de or adressen_support@pei.de .

No, there is no "refresh button". However, you can refresh the site through the browser.

No, according to section 22 (2) No. 5 AMG, the applicant must already provide proof at the time of the marketing authorisation application that he has a qualified person according to § 63a AMG and the contact details of this person must be provided. This corresponds to Annex 1.8.1 of module 1 of the marketing authorisation form and thus to the European requirements, cf. Art. 104 (3) of Directive 2001/83/EC. In this respect, the information on the designated graduated plan officer is required in every marketing authorisation application.

As before, this obligation and the obligation to notify changes to this information remain unaffected by the obligation to notify according to section 63a AMG.

According to the Variation Regulation1234/2008 and the note to C.I.8. of the Classification Guideline (2013/C 223/01), a notification to the Art.57 database is sufficient for the notification of changes to the above mentioned information instead of a variation. With the notification in the Art.57 database, the data on the QPPV are updated.

For medicinal products for which the Variation Regulation (EC) No. 1234/2008 does not apply, but for which the national Variation Regulation of section 29 AMG continues to apply, a notification of variation pursuant to section 29 AMG (“Änderungsanzeige”) must be submitted. Therefore, a notification of change according to section 29 AMG must continue to be submitted to the portal for each medicinal product concerned in addition to the notification according to section 63a AMG.

Possible exceptions:

For blood components and non-directed allogenic stem cell preparations from umbilical cord blood according to section 21 (1) AMG as well as for autologous and directed stem cell preparations from bone marrow, peripheral blood or umbilical cord blood according to section 21a (1) AMG, the submission of an additional notification of change according to section 29 AMG is not required in deviation from the above-mentioned regulation, provided that a reference to the information in the Article 57 database is included in the dossier (marketing authorisation or application for authorisation) instead of the contact details of the graduated plan officer.

• In the marketing authorisation application for blood components and non-directed allogenic stem cell preparations from umbilical cord blood in module 1.2 (application form ) under item 3.3 (Responsible Qualified Person for the Safety of Medicinal Products – “Stufenplanbeauftragter”, graduated plan officer).
  
• In the marketing authorisation application for autologous and directed stem cell preparations from bone marrow, peripheral blood and umbilical cord blood, respectively, in Module 1.2 (application form) under 1.2.3.3 (“Stufenplanbeauftragter” – graduated plan officer).

Dossiers that already contain contact details of the graduated plan officer can be adapted accordingly by means of a notification of change.

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 designation or notification is missing, an administrative offense pursuant to section 97 (2) No. 24c AMG ist to be considered.

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 noted that another graduated plan officer (deputy) must be reported for the excluded products. In this case, it is expedient to specify the PSMF or MFL number of the pharmacovigilance system masterfile (PSMF). The MFL number is a unique code (MFL EVCODE) assigned by the eXtended EudraVigilance Medicinal Dictionary (XEVMPD) at the EMA. For more information, see the EMA Q&A document at:

https://www.ema.europa.eu/en/documents/other/chapter-3ii-xevprm-user-guidance-detailed-guidance-electronic-submission-information-medicinal_en.pdf

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 officer, the tasks according to section 19 AMWHV are particularly relevant: systematic recording of complaints as well as informing the competent local (“Länder”) authority about any defect that could lead to a recall or to an unusual restriction of distribution. This applies in particular to pharmaceutical-technically determined risks in the case of quality defects and batch recalls.

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 according to Art. 21 and 48 of Regulation (EC) No. 726/2004.

For the other obligations, some of which go beyond the duties of the EU-QPPV, including those under section 19 AMWHV, the pharmaceutical entrepreneur must ensure that a person is appointed, who assumes these duties.

If the EU-QPPV is not proficient in German, this supporting person should assist the EU-QPPV linguistically or through language mediation.

Even if this person is not himself a graduated plan officer, he is nevertheless entrusted with the performance of the tasks of the graduated plan officer within the meaning of the AMWHV and should in this respect be reported via this portal.

Please indicate in the comment field that a person equivalent to the graduated plan officer is notified, as only centralised marketing authorisations are hold.

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 be indicated on the form.

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 PharmNet.Bund portal and must be made separately. For information on the respective reporting requirements of the local authority, please contact this authority directly.