Eine sachkundige Person nach dem Arzneimittelgesetz anzeigen

Any pharmaceutical entrepreneur who manufactures medicinal products within the meaning of Section 2 para. 1 or para. 2 no. 1 AMG or places them on the market in accordance with Section 4 para. 17 AMG must notify the competent authority of a qualified person.

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 for submission to the authorities.

Declaration of commitment

Apart from the declaration of commitment, the other documents are not mandatory. This depends on existing documents and plausibility in the individual case.

Qualified persons must have the necessary expertise and reliability.

They must have a university degree in pharmacy, chemistry, biology, human or veterinary medicine

You can notify a competent person in writing, by e-mail 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 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 application can be confirmed or rejected,

The decision will be communicated to the person making the application.

A statement of fees will then be drawn up and also sent to the applicant with a request for payment.

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

The notice of costs contains information on legal remedies.

Notification of the qualified person in accordance with Section 14 of the Medicinal Products Act, Section 14 when applying for a license (initial notification) Section 20 AMG when changing a qualified person

The German Medicinal Products Act describes the requirements for various responsible persons.

In order to obtain a manufacturing authorization as a pharmaceutical entrepreneur, the competent authority must be notified of a qualified person with the appropriate qualifications and reliability.

For the corresponding notification of responsibility, please use the online service or submit the document in writing. Notification to the trade supervisory authorities is also possible by e-mail.

In Lower Saxony, drug monitoring is ensured by the central state trade supervisory offices in Braunschweig, Hanover, Lüneburg and Oldenburg.