Informationsbeauftragte für Pharmazieunternehmen anzeigen

Arzneimittelgesetz (AMG)

• § 74a

Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)

• § 12

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.

• 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

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

There are no costs for the advert.

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.

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

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

• Objection
• Information on how to lodge an objection will be sent with the decision on your advert.