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

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.

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:27.10.2023

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

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  • 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
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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.