Manufacture of medicinal products; notification of subsequent changes and change of qualified person

If there are 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.

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).