Information - Services - Formalities by subjects - Business start-up preparations - General - Pharmaceutical manufacturing; application for a permit for tissue collection and laboratory testing. - Dienstleistungsportal Bayern

Description

Anyone wishing to obtain tissue or perform laboratory tests in this context must apply for a permit in accordance with Section 20b 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 b AMG.

Procedure

The application must be submitted informally to the relevant 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 (ohne Unterschrift)

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

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 1.1.2.1). 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

• § 20b 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. § 20b Abs. 1 AMG für die Gewinnung von Gewebe oder die für die Gewinnung erforderlichen Laboruntersuchungen