Pharmaceutical manufacturing; application for a permit for the treatment or processing, preservation, testing, storage, or placing on the market of tissues or tissue preparations.

The processing, preservation, testing, storage or placing on the market of tissues or tissue preparations is subject to authorization.

Description

Anyone wishing to process, preserve, test, store or place on the market tissue or tissue preparations must apply for a permit in accordance with Section 20c of the German Medicines Act (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.

Prerequisites

The requirements result from § 20 c AMG.

Procedure

Notification shall be made informally to the appropriate government.

Processing time

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

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.

Fees

  • A fee of between €500 and €20,000 is set on the basis of the administrative effort and time involved and the importance of the matter for the applicant (according to Schedule of Costs - Tariff No. 7.IX.8/Tariff item 1.1.3.1). This also includes expenses for necessary site inspections by our pharmaceutical officials (according to the schedule of costs - tariff no. 7.IX.8/tariff item 1.2).

Legal bases

Remedy

Administrative court proceedings; information

Administrative court action

Links to more information

Status:13.10.2022

Responsible for editing:Bayerisches Staatsministerium für Gesundheit und Pflege

Contains machine translated content. Show the original content

  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
Bild zur Leistungsbeschreibung

Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.

Top of page