Medicinal products; notification of a clinical trial
Clinical trials under the German Medicines Act are subject to notification.
Description
Anyone wishing to conduct clinical trials according to §§ 40ff. Medicines Act (AMG) must notify the government responsible for the notifying party (sponsor, CRO, laboratory, trial facility) (Section 67 AMG).
The notification can be made by e-mail to the responsible government using a prescribed form.
- Government of Upper Franconia: responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia.
- Government of Upper Bavaria: responsible for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia
Prerequisites
The requirements result from § 40ff. AMG.
Procedure
The notification must be made to the relevant government using the prescribed form.
Deadlines
Confirmation of the notification can take place after all required documents have been submitted and open questions have been clarified. The AMG does not set any deadlines.
Status: 13.10.2022
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited