Your position:  Homepage » For Companies » Batch Release

content

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 21 March 2024 (PDF, 437 kB)

New starting 01.03.2024: Send SSC notifications to PEI

Starting March 1st, 2024 it is possible to use the SunsetClause Portal to send SSC notifications to PEI. The portal can  be used to submit notifications that announce when a product has been placed on the market and when it has been withdrawn from the market*.

Please note that batch release applications may only be submitted after the notification that the product is on the market has been submitted.

*pursuant to section 29 subsection1b and 1c AMG and section 141 subsection 7 AMG

 

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.

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.

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: 3/22/24

Your position:  Homepage » For Companies » Batch Release

This website uses session cookies to ensure login to closed areas. In order to optimize the website, we use the analysis tool Matomo. Our Matomo installation works without tracking cookies. You will find more detailed information and the possibilities to object to the use of Matomo in our data privacy declaration.