Medicinal products; notification of a clinical trial

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.

Preconditions
The requirements result from § 40ff. AMG.
The notification is to be made to the competent government using the prescribed form.

Responsible for the content
Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian State Ministry of Health and Care)

Last update or date of publication
24.09.2020