Arzneimittelherstellung; Anzeige von nachträglichen Änderungen und des Wechsels der sachkundigen Person
Bayern
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99005023008000
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Typ 2/3
Inhalt
Manufacture of medicinal products; notification of subsequent changes and change of qualified person
Begriffe im Kontext
nicht vorhanden
Fachlich freigegeben am
12.05.2025
Fachlich freigegeben durch
Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention (Bavarian State Ministry of Health, Care and Prevention)
- § 20 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
- § 13 Abs. 1 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
- Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)
Changes to a manufacturing authorization in accordance with Section 13 of the German Medicinal Products Act must be notified.
If there are any changes to a manufacturing authorization issued in accordance with Section 13 of the German Medicinal Products Act (AMG), these must be notified immediately in advance (Section 20 AMG).
The notification can be sent informally by e-mail to the responsible 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 facts reported, the documents to be submitted may differ considerably.
Please check with the appropriate authority for the required documentation.
Depending on the nature of the notified change, the authorization pursuant to Section 13 AMG may have to be amended by the drug regulatory authority.
A fee of between €500 and €50,000 is set on the basis of the administrative work and time involved and the importance of the matter for the applicant (according to the schedule of costs - tariff no. 7.IX.8/tariff item 1.1).
The statutory processing period is a maximum of three months. The period begins when all documents and information are complete.