Informationsbeauftragte nach dem Arzneimittelgesetz anzeigen

If you as a pharmaceutical company place finished medicinal products on the market, you must appoint a person with the necessary expertise and reliability to be responsible for providing scientific information about the medicinal products.

Information officers must have the necessary expertise and reliability in accordance with the Medicinal Products Act.

In particular, they are responsible for ensuring that no medicinal products are placed on the market with misleading names, information or presentation and that

• the labeling,
• the package leaflet,
• the information for healthcare professionals and
• the advertising

complies with the content of the marketing authorization or registration of the medicinal products.

• Employment references (copy)
• Training certificates (copy)
• Curriculum vitae
• Certificate of good conduct (sent directly to the authority by the Federal Office of Justice)

• Information officers must have the necessary expertise and reliability.
• No specific proof of expertise is required.
• A (relevant) scientific background is required in order to be able to fulfill the task of providing scientific information on medicinal products.

You can notify a competent person in writing or online.

• You notify the information officer(s) by means of a written application or using the online service.
• The authority will check the notification formally and for completeness.
• If any documents are found to be missing during the check, the missing documents will be requested.
• Once the formal check has been passed, the competent authority will make a decision.
• The notification can be confirmed or rejected. The decision on costs is also issued with this letter.

You must notify new information officers and any changes in advance. You must notify us immediately of any unforeseen changes.

A fine may be imposed in the event of a violation.

• Objection
  You will receive information on how to lodge an objection with the decision on your complaint.

• Notification of information officer
• Pharmaceutical companies that place finished medicinal products on the market must appoint an information officer. The competent authority must be notified of this person and of any changes.
• Information officers must have the necessary expertise and reliability.
• Companies submit the notification by post.
• Responsible: competent authority of the federal state

Please contact the Thuringian State Office for Consumer Protection, Department 24.