responsibility finder
Schleswig-Holstein

Notify a competent person in accordance with the Medicinal Products Act

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

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.


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 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.

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.

Technically approved by

Ministry of Justice and Consumer Protection of the Free and Hanseatic City of Hamburg

Professionally released on

06.05.2022

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 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.

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.

Technically approved by

Ministry of Justice and Consumer Protection of the Free and Hanseatic City of Hamburg

Professionally released on

06.05.2022

Further information and offers