Law library  /  AMG  /  Section 20
Medicinal Products Act · Chapter 3 · Manufacture of medicinal products
Section 20

Notification obligations

§ 20 AMG · Anzeigepflichten

Arzneimittelgesetz (AMG) – Gesetz über den Verkehr mit Arzneimitteln · German text as of 29 October 2026 · translation edited by Alexander Baranov

#

The holder of the authorisation shall notify the competent authority in advance of any change to any of the particulars referred to in section 14(1), submitting the supporting evidence.

Der Inhaber der Erlaubnis hat jede Änderung einer der in § 14 Abs. 1 genannten Angaben unter Vorlage der Nachweise der zuständigen Behörde vorher anzuzeigen.

#

In the event of an unforeseen change of the qualified person under section 14, the notification shall be made without undue delay.

Bei einem unvorhergesehenen Wechsel der sachkundigen Person nach § 14 hat die Anzeige unverzüglich zu erfolgen.

Does § 20 AMG affect your product?

Background: Manufacturing and import authorisation · Pharma market access in Germany · Four routes to a German marketing authorisation. We explain what this provision means for your launch, price and timeline — fixed price, in writing.

Fixed-price assessmentBook a session

Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026. Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.