Paul-Ehrlich-Institut

Fees

Information on handling of fees for Clinical Trials

Initial Requests for Clinical Trial Approval

The fee notice shall be addressed to the sponsor and shall be sent to the sponsor after the decision on the approval. If the Notice of the fees is to be addressed to another organization or to be sent to another organization, the accepting organization will be required to provide a statement of acceptance of the charges in the first case, otherwise information about the different address, preferably an e-mail address for electronic sending, is required.

Please send this to pei@pei.de with the subject "Clinical Trial Fee Acceptance Declaration" or the abbreviation GUERK KLP and the internal accession number (Vorlagenummer) as the subject.

Amendments to Clinical Trial approvals

The fee notice shall be addressed to the sponsor and shall be sent to him after the decision on approval or, if the Paul Ehrlich Institut has received a fee acceptance declaration, to the organization named herein. If the fee notice is to be addressed to another organization or to be sent to another organization, the accepting organization will be required to provide a statement of acceptance in the first case, otherwise information on the different address, preferably an e-mail address for electronic sending, is required.

Please send this to pei@pei.de with the subject line "Clinical Trial Fee Acceptance Declaration Amendment" or the abbreviation GUERK AMD and the internal accession number (Vorlagenummer) as the subject.

Letter of receipt for DSURs

The fee notice shall be addressed to the Applicant of the DSUR and shall be sent to him after the assessment or, if the Paul Ehrlich Institut has received a fee acceptance declaration, to the organization named herein. If the fee notice is to be addressed to another organization or to be sent to another organization, the accepting organization will be required to provide a statement of acceptance in the first case, otherwise information on the different address, preferably an e-mail address for electronic sending, is required.

Please send this to pei@pei.de with the subject line DSUR Fee Acceptance Declaration or the abbreviation GUERK DSUR and the internal accession number (ASR/ DSUR Number) as the subject.

Queries

Please direct any queries to pei@pei.de.

Minimal Information for transmission

Identification of the clinical trial (EudraCT number; submission (PEI-accession) number: or ASR/DSUR number, if applicable)
Name of the organization
Street; Number
Postcode; City
Country
Email address
Identification number of the transaction e.g. invoice number

Transmission by Email to: pei@pei.de

Updated: 06.08.2019