Informationsbeauftragte für Pharmazeutische Unternehmer anzeigen

If you are a pharmaceutical entrepreneur who places finished medicinal products on the market, you must notify the competent authority of an information officer.

If you are a pharmaceutical entrepreneur who places finished medicinal products on the market, you must notify the competent authority of an information officer. Any changes must also be reported immediately.

The law stipulates that the competent authority must be notified of an information officer with the appropriate expertise and reliability.

Employment references (copy)

Proof of training (copy)

Curriculum vitae

Certificate of good conduct for submission to the authorities

Declaration of commitment

The information officer must have the necessary expertise and reliability.

You can notify an information officer in writing or online:

You notify the information officer by means of a written application or using the online service. Proof of the person's expertise must be attached to the notification.

Upon receipt, the authority checks the notification formally and for completeness.

If the check reveals that documents are missing, the person making the notification will be contacted and asked to provide the missing documents.

Once the missing documents have been submitted or the formal check has been passed, the competent authority will make a decision.

The application can be confirmed or rejected.

You will be notified of the decision.

A statement of fees will then be drawn up and sent to you with a request for payment.

Immediately report any changes.

Information on how to lodge an objection will be sent with the decision on your complaint.

Information Officer or Information Officer Notification

A pharmaceutical company that places finished medicinal products on the market must appoint an information officer. The information officer must be notified to the competent authority.

An information officer must be appropriately qualified and reliable.

For the corresponding notification of responsibility, please use the online service Personnel changes in accordance with the Medicinal Products Act or send the written notification by post or e-mail.

In Lower Saxony, drug monitoring is ensured by the central state trade supervisory offices in Braunschweig, Hanover, Lüneburg and Oldenburg in accordance with the ZustVO NPOG