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 means of a prescribed form by e-mail to the competent government.
- 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 is to be made to the competent government using the prescribed form.
Deadlines
Confirmation of the notification can take place after all necessary documents have been submitted and open questions have been clarified. The AMG does not set any deadlines.
Fees
Costs for the confirmation of the advertisement: 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.
Status: 11.10.2021
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