Pharmaceutical legislation; import permit and certificates for tissues and certain tissue preparations

The import of tissue / tissue preparations from a third country is subject to authorization.

Description

Tissue in the sense of § 1a number 4 of the Transplantation Act or tissue preparations in the sense of § 20c paragraph 1 sentence 1 or sentence 2 of the German Medicines Act (AMG) may only be imported with permission. The decision on the granting of permission is made by the competent authority of the state in which the operating site of the importing tissue establishment is located, in consultation with the competent higher federal authority (Paul Ehrlich Institute).

The permit can be applied for 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

The requirements result from § 72 b AMG.

Procedure

Notification shall be made informally to the appropriate government.

Processing time

The statutory processing period is 3 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.

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

Fees

  • A fee of between €200 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 6.4 and 6.5). 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 6.9).

Remedy

Administrative court proceedings; information

Administrative court action

Status: 14.09.2022

Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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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.