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Schleswig-Holstein

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Informing information officers for pharmaceutical companies

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

If you are a pharmaceutical entrepreneur and place finished medicinal products on the market, you must notify the competent authority of an information officer. In addition, any changes must be reported immediately.

Information officers must have the necessary expertise and reliability in accordance with the Medicinal Products Act.

Among other things, they are responsible for ensuring that the following complies with the content of the marketing authorization or registration of the medicinal products:

  • the labeling,
  • the package leaflet,
  • the information for healthcare professionals and
  • the advertising.

You must send your notification to the competent authority in the respective federal state.


Process flow

You can notify information officers by post:

  • Send your notification with the required documents to the competent authority.
  • The authority will check the notification formally and for completeness.
  • If your documents are incomplete, the authority will ask you to submit missing documents.
  • Once the formal check has been passed, the authority will decide whether to confirm or reject the notification.
  • The authority will inform you of its decision.
  • The authority will then draw up a list of fees and send it to you with a request for payment.
Who should I contact?

To the State Office for Social Services of the State of Schleswig-Holstein.

Requirements
  • Information officers must have the necessary expertise and reliability.
  • Have the necessary expertise:
    • Pharmacists
    • Persons who have completed a university degree including a certificate of examination in pharmacy, chemistry, biology, human or veterinary medicine
    • Pharmacy assistants
    • Persons who have completed training as technical assistants in pharmacy, chemistry, biology, human or veterinary medicine
    • Pharmaceutical sales representatives
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?

You must notify new information officers and any changes in advance. You must notify us immediately of any unforeseen changes.

Legal basis
Appeal
  • Objection
    You will receive information on how to lodge an objection with the decision on your complaint.
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.

Teaser

If you are a pharmaceutical entrepreneur and place finished medicinal products on the market, you must notify the competent authority of an information officer. In addition, any changes must be reported immediately.

Process flow

You can notify information officers by post:

  • Send your notification with the required documents to the competent authority.
  • The authority will check the notification formally and for completeness.
  • If your documents are incomplete, the authority will ask you to submit missing documents.
  • Once the formal check has been passed, the authority will decide whether to confirm or reject the notification.
  • The authority will inform you of its decision.
  • The authority will then draw up a list of fees and send it to you with a request for payment.

Who should I contact?

To the State Office for Social Services of the State of Schleswig-Holstein.

Requirements

  • Information officers must have the necessary expertise and reliability.
  • Have the necessary expertise:
    • Pharmacists
    • Persons who have completed a university degree including a certificate of examination in pharmacy, chemistry, biology, human or veterinary medicine
    • Pharmacy assistants
    • Persons who have completed training as technical assistants in pharmacy, chemistry, biology, human or veterinary medicine
    • Pharmaceutical sales representatives

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?

You must notify new information officers and any changes in advance. You must notify us immediately of any unforeseen changes.

Legal basis

Appeal

  • Objection
    You will receive information on how to lodge an objection with the decision on your complaint.

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.

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