Information on the hearing to report according to § 8d sentence 3 Transplantation Act (TPG)

Basically: Please complete the form in the letter of formal notice and send it to eSubmission@pei.de. Please refer to the four-digit ID number mentioned in the letter.

FAQ

Report pursuant to Section 8d (3) sentence 2 Transplantation Act (TPG) - Hearing in the proceedings concerning fines to be paid in accordance with Section 55 Administrative Offences Act (Gesetz über Ordnungswidrigkeiten, OWiG)

What does the reporting obligation involve?

This obligation is based on Section 8d sentence 3 Transplantation Act (Transplantationsgesetz, TPG). All information can be found on the website of the Paul-Ehrlich-Institut (PEI).

We have already submitted the TPG template to the Paul-Ehrlich-Institut (PEI). How do I proceed now?

If you have already submitted the TPG template to the PEI, the procedure concerning fines to be paid will be automatically cancelled. There are no further steps required on your part.

My notification as a clinical tissue facility (e.g. for tissue removal) is communicated via a processing tissue facility that transmits the notification to the PEI in a coordinated manner for all contracted facilities. We understand that the PEI already has this information. Please inform us about the further procedure.

In this case the penalty procedure will be set automatically. There are no further steps required on your part.

Why is our facility receiving a letter of formal notice even though it is not a clinical tissue facility and we have never reported to the PEI either?

In some facilities (e.g. removal of cartilage cells, umbilical tissue, or skin), the message is coordinated across the processing tissue facility. Please check whether your facility is a contract provider, e.g. as a facility that collects tissues for a processing facility. If the contractual obligation is still in place, please provide the PEI directly (or through the tissue processing facility) with the appropriate notification for 2018. Otherwise, please inform the PEI that the contractual obligation no longer exists.

The subject is the four-digit ID number listed in the letter you received from the PEI.

Enclosed I am sending you the completed TPG registration form / the pending notification according to Section 8d sentence 3 TPG. Will I still have to send the hearing form to the PEI?

With timely submission of the completed TPG registration form, the penalty procedure will be cancelled automatically. There are no further steps required on your part.

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