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.
Tissue within the meaning of Section 1a No. 4 of the Transplantation Act or tissue preparations within the meaning of Section 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.
The requirements result from § 72 b AMG.
Notification shall be made informally to the appropriate government.
The statutory processing period is 3 months at the longest. The period begins to run when all documents and information are complete.
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)
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.
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).
Links to more information
Responsible for editing:Bayerisches Staatsministerium für Gesundheit und Pflege
- 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