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.

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.

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.

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

Send SSC notifications to PEI

Since March 1st, 2024 it is possible to use the Sunset Clause 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can be used to submit notifications that announce when a product has been placed on the market and when it has been withdrawn from the market, pursuant to section 29 subsection1b and 1c AMG and section 141 subsection 7 AMG.

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

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.