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Manufacture of medicinal products; notification of subsequent changes and change of qualified person
Changes to a manufacturing authorization in accordance with Section 13 of the German Medicinal Products Act must be notified.
Forms
Forms
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Erklärung der bestellten sachkundigen Person gemäß §14 des Arzneimittelgesetzes (AMG)
This form can be submitted electronically (e.g. via a secure contact form using your user account with login via the electronic ID function or the ELSTER certificate) or handwritten and signed in paper form to the responsible authority.
Responsible for you
For contact details of the responsible authoritiy and local valid information select under "Select location" a location.
Procedure details
Description
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
Requirements
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.
Required documents
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Depending on the facts reported, the documents to be submitted may differ considerably.Please check with the appropriate authority for the required documentation.
Proceedings
The notification must be made informally to the responsible government.
Fees
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).
Deadlines
The notification must be made before the intended change.
Processing time
The statutory processing period is a maximum of three months. The period begins when all documents and information are complete.
Legal bases
Appeal
Administrative court action
Related issues
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Medicinal products; application for authorization to manufacture medicinal products for human use and active substances requiring authorization
You require a manufacturing authorization if you wish to manufacture medicinal products within the meaning of Section 2 (1) or (2) of the Medicinal Products Act, test sera, test antigens or other specific active substances for the purpose of supplying them to others.
Status: 12.05.2025
Editorial responsibility Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
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