Procedure descriptions

Show information officers for pharmaceutical companies

If you operate a pharmaceutical company that 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 information officer must have the appropriate expertise and reliability .

They are responsible, among other things, for ensuring that medicinal products are correctly registered, properly labelled and not misleadingly advertised.

Forms/Online Services

Responsible authority

Drug Monitoring Centre Baden-Württemberg at the Regional Council of Tübingen

Regierungspräsidium Tübingen

Hausanschrift

Konrad-Adenauer-Straße 20
72072 Tübingen
To the electronic timetable information

Contact

Telefon (0 70 71) 7 57-0
Fax (0 70 71) 7 57-31 90
E-Mail poststelle@rpt.bwl.de
De-Mail poststelle.rpt@im.bwl.de-mail.de
Servicekonto Sichere Servicekonto-Nachricht über service-bw.de senden

Details

Prerequisite

  • Information officers must have the necessary expertise and reliability (see Section 74a of the German Medicinal Products Act)

Procedure

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 notification can be confirmed or rejected.
  • You will be informed of the decision.
  • A statement of fees will then be drawn up and sent to you with a request for payment.

Deadlines

Any change must be notified in advance. In the event of an unforeseen change of information officer, notification must be given immediately.

Required documents

  • Employment references (copy)
  • Proof of training (certified copy)
  • Curriculum vitae
  • Certificate of good conduct (document type O for direct transmission from authority to authority)
  • Form "Declaration of nomination"
  • Declaration of commitment

Costs

There are no costs for the advert.

Miscellaneous

A fine may be imposed if the obligation to notify is violated.

Legal basis

Arzneimittelgesetz (AMG)

  • § 74a

Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)

  • § 12

Release note

machine generated, based on the German release by: Sozialministerium Baden-Württemberg, 29.11.2023