Information - Services - Formalities by subjects - Preparations for business start-up - Allgemeines - Manufacture of medicinal products; notification of subsequent changes and change of qualified person - Dienstleistungsportal Bayern

Description

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.

Prerequisites

Depending on the nature of the notified change, the authorization according to § 13 AMG may have to be changed by the drug supervisory authority.

Procedure

The notification shall be made informally to the competent government.

Deadlines

The notification must be made before the intended change.

Processing time

The statutory processing period is three months at the longest. The time limit begins to run when all documents and information are complete.

Required documents

• Depending on the facts reported, the documents to be submitted may differ considerably.

  Please check with the appropriate authority for the required documentation.

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

• Prefillable Form, Bavaria-wide: Formloser Antrag (mit Unterschrift)

  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.

  Dieser Assistent unterstützt Sie bei der Erstellung eines formlosen Schreibens, wenn die zuständige Stelle kein Antragsformular zur Verfügung stellt.

Fees

• A fee of between €500 and €50,000 is set on the basis of the time and material administrative expense incurred and the importance of the matter for the applicant (according to the Schedule of Costs - Tariff No. 7.IX.8/Tariff item 1.1).

Legal bases

• § 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)

Remedy

Administrative court action