Medicinal products; notification of a clinical trial
Clinical trials under the German Medicinal Products Act are subject to notification.
The requirements result from § 40ff. AMG.
The notification must be made to the responsible government using the prescribed form.
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.
Anzeige einer klinischen Prüfung
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.
Costs for the notification confirmation: €50 to €5,000 (according to the list of costs - tariff no. 7.IX.8 / tariff item 220.127.116.11)
They are to be borne by the advertiser.
Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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