Paul-Ehrlich-Institut

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Regulation

Advice

Application Observations

Submitting a notification regarding a non-interventional study (NIS) in accordance with section 67 subsection 6 of the German Medicinal Products Act (AMG; German only)
Anzeige einer nicht-interventionellen Unbedenklichkeitsprüfung gemäß § 63f Absatz 1 Arzneimittelgesetz (AMG) (German only)

Approval of ATMP

Notify the Administration of an ATMP not Subject to a Marketing authorisation in a Patient

Notifying the Use of an ATMP Pursuant to 67 (9) AMG

Approval of Tissue Preparations

Batch Testing Human

Blood - Link to overview

Sample Texts and Templates

Fees

Inspections

Form - Request for participation of a Paul-Ehrlich-Institut expert in an inspection (Word document, German only)

Parallel Trade

Field Trials Veterinary

WHO Certificates

IVD

Form: Inclusion of antigen tests in the tables according to section 1 sentence 1 of the Coronavirus Testing Ordinance (German only)

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