Information - Services - Formalities by subjects - Preparations for business start-up - Allgemeines - Medicinal products; notification of a clinical trial - Dienstleistungsportal Bayern

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.

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 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.

Legal bases

• § 79 TAMG - Einzelnorm (gesetze-im-internet.de)
• § 40 ff. Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Remedy

Administrative court action