Notify a competent person according to the Medicines Act

• Competent persons must have the necessary expertise and reliability.
• You need 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

• Job references (copy)
• Training certificate (copy)
• CV
• Certificate of good conduct (copy)
• Declaration of designation form
• commitment declaration

Violation will result in a fine.

• You can notify a competent person in writing or online.
• You indicate the competent person by means of a written application or by means of the online service.
• The notification is then received by the authorities.
• The authority checks the notification formally and for completeness.
• If the check reveals missing documents, the person who created the ad will be contacted and asked to provide the missing documents.
• After submitting the missing documents or after passing the formal examination, the competent authority will make a decision.
• The ad can be confirmed or rejected.
• The decision will be communicated to the person making the complaint.
• A list of fees will then be drawn up and sent to the person making the notification, with a request for payment.

The requirements for various responsible persons are described in the Medicines Act. There, a competent person with appropriate qualifications and reliability is to be reported to the competent supervisory authority for the decision on the manufacturing license.
For the corresponding display of responsibility, please use this online service.
To prove your expertise, please provide the relevant certificates and proof of experience via the online service.