Information - Services - Formalities by subjects - Preparations for business start-up - Allgemeines - Manufacture of medicinal products; application for a licence for the working or processing, preservation, testing, storage or placing on the market of tissues or tissue preparations - Dienstleistungsportal Bayern

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

The notification shall be made informally to the competent government.

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.

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 € 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 the 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

• § 20c 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

Links to more information

• Merkblatt: Voraussetzungen zur Erteilung einer Erlaubnis gem. § 20c Arzneimittelgesetz (AMG) für Gewebezubereitungen, die nicht mit industriellen Verfahren hergestellt werden und deren Be- oder Verarbeitungsverfahren hinreichend bekannt sind - Gewebezubereitung bekannt, nicht industriell - Merkblatt zum Antrag auf Erlaubnis