Anzeige der sachkundigen Person gemäß Arzneimittelgesetz Bestätigung

If you operate a pharmaceutical company that places finished medicinal products on the market, you must notify the competent authority of a qualified person. Any changes must also be reported immediately.

The requirements for various responsible persons are described in the Medicinal Products Act. It stipulates that you must notify the competent authority of a competent person with appropriate qualifications and reliability for the decision on manufacturing authorization. Any changes must also be reported immediately.

• Employment references (copy)
• Proof of training (copy)
• Curriculum vitae
• Certificate of good conduct (copy)
• Form "Declaration of nomination"
• Declaration of commitment

• Qualified persons must have the necessary expertise and reliability.
• They require a university degree in pharmacy, chemistry, biology, human or veterinary medicine,
• Alternatively, completed training in the aforementioned areas or proof of employment as a pharmaceutical representative.

You can notify a qualified person in writing or online.

• You notify the competent person by means of a written application or using the online service.
• The notification is then received by the authority.
• The authority checks the notification formally and for completeness.
• If the check reveals missing documents, the person who made the report is 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 report can be confirmed or rejected.
• The decision will be communicated to the person making the notification.
• A statement of fees will then be drawn up and also sent to the person making the report with a request for payment.

Fictitious approval: To be notified immediately upon change.

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

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

• Notification of the competent person in accordance with Section 14 of the Medicinal Products Act
• The Medicinal Products Act describes the requirements for various responsible persons.
• In order to obtain a manufacturing authorization as a pharmaceutical company, a competent person with the appropriate qualifications and reliability must be notified to the competent supervisory authority.
• For the corresponding notification of responsibility, please use the online service or submit the document in writing.
• Competent authority:

Forms available:

Written form required: Yes

Informal application possible: Yes

Personal appearance necessary: No

Online services available: Yes