Notify a competent person in accordance with the Medicinal Products Act
Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)
Service Description
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.
Teaser
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.
Process flow
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.
Who should I contact?
To the State Office for Social Services of the State of Schleswig-Holstein.
Requirements
- 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 duration
Processing time: 1 - 4 Weeks
Legal basis
Appeal
- Objection
- Information on how to lodge an objection will be sent with the decision on your complaint.
Applications / forms
Forms available:
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.
Author
The text was automatically translated based on the German content.