Manufacture of medicinal products; notification of subsequent changes and change of qualified person
Changes with regard to a manufacturing authorisation pursuant to Section 13 of the German Medicines Act are subject to notification.
If there are changes to a granted manufacturing authorisation according to Section 13 of the German Medicines Act (AMG), these must be notified in advance without delay (Section 20 AMG).
The notification can be sent informally 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.
Depending on the nature of the notified change, the authorization according to § 13 AMG may have to be changed by the drug supervisory authority.
The notification shall be made informally to the competent government.
The notification must be made before the intended change.
The statutory processing period is three months at the longest. The time limit begins to run when all documents and information are complete.
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
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