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Notify a competent person in accordance with the Medicinal Products Act
Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)
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.
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 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 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.
Who should I contact?
To the State Office for Social Services of the State of Schleswig-Holstein.
- 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.
Which documents are required?
- Employment references (copy)
- Proof of training (copy)
- Curriculum vitae
- Certificate of good conduct (copy)
- Form "Declaration of nomination"
- Declaration of commitment
What deadlines do I have to pay attention to?
Fictitious approval: To be notified immediately upon change.
Processing time: 1 - 4 Weeks
- Information on how to lodge an objection will be sent with the decision on your complaint.
Applications / forms
Written form required: Yes
Informal application possible: Yes
Personal appearance necessary: No
Online services available: Yes
What else should I know?
A fine may be imposed in the event of a violation.
The text was automatically translated based on the German content.
Technically approved by
Ministry of Justice and Consumer Protection of the Free and Hanseatic City of Hamburg
Professionally released on