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Batch release applications (PEI-C Rebuild)

Holder of marketing authorizations for medicinal products are able to submit batch release applications pursuant to section 32 of the German Medicinal Products Act (Arzneimittelgesetz) electronically by using this portal.

The application may include all related documentation. It’s not necessary to submit any documentation via mail in parallel.

A batch release is a certification of a medicinal product or a drug by an authorized person. The batch release must be done before the products are introduced into free trade.

The application is available 24 hours a day (except Thursdays, 5:00-6:30).

Release Notes for the new version from 29 September 2022 (PDF, 558 kB)

Download of Certificates

As of 01.01.2022, batch release certificates for electronically submitted batch release applications will be available for download in the application.

The pharmaceutical company can print out the batch release documents from the portal if required. Thus, a separate application for additional uncertified copies will no longer be necessary.

Certified copies can still be applied for via PEI-C Rebuild at an extra cost.

 

Entering and submitting an application is subject to the four-eyes principle.

For the sample containers to be sent to the Paul Ehrlich Institute (PEI) there is the possibility to print a delivery slip. With this delivery slip it will be easily possible to assign the sample containers correctly to the unit responsible for testing within PEI.

Access and user authorisation

There is a role-based, central authentication and registration for the access to applications. The roles differentiate between the administrator in the higher federal authorities and the main user(representative) in a company or an authority. Other users are created and administrated by the representative.

In addition to customer data a X.509-certificate is needed for a first registration. This ensures sufficient safety for authentication and authorization.

More information about the certificate, request access authorization and user administration can be found in the user manuals below.

Last modified: 9/29/22

Your position:  Homepage » For Companies » Batch Release

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