Medicinal products; notification of a clinical trial

Clinical trials under the German Medicinal Products Act are subject to notification.

Description

Prerequisites

The requirements result from § 40ff. AMG.

Procedure

The notification must be made to the responsible government using the prescribed form.

Deadlines

The notification can be confirmed once all the necessary documents have been submitted and any unanswered questions have been clarified. The AMG does not set any deadlines.

Forms

  • Form, Bavaria-wide: Anzeige einer klinischen Prüfung
    Please note

    This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

Fees

  • Costs for the notification confirmation: €50 to €5,000 (according to the list of costs - tariff no. 7.IX.8 / tariff item 1.1.4.3)

    They are to be borne by the advertiser.

Remedy

Administrative court proceedings; information

Administrative court action

Status:20.01.2024

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.