Apply for batch release of Sera as a veterinary medicinal product

You can apply for batch release online or by post and, in exceptional cases, by e-mail.

Online application:

• Call up the online service PEI-C Rebuild.
  • In order to use PEI-C Rebuild, you need to register using the RuBen application.
  • With RuBen you register your company and can then set up a self-managed user administration for your company.
• Create your application for PEIC Rebuild and submit it online with all the required documents.
• Send your test samples to the Paul-Ehrlich-Institut by post.
• After successful verification by the PEI, you will receive the national release notice and/or an EU certificate, if requested, by post or you can retrieve both in PEI-C Rebuild.

Immunological veterinary medicinal products may only be placed on the market or used in Germany if they have been authorized by the PEI or the European Union.

The batches you send us must meet the criteria specified in the marketing authorization of the veterinary medicinal product with regard to

• quality,
• safety and
• efficacy.

• Application for batch release
• Manufacturing and test records
• Test samples of the manufactured batches

If the batch was released in another member state of the European Union (EU):

• Certificate of release (EU certificate) in addition to the above-mentioned documents

The national release decision has a period of validity, i.e. it is valid until the end of the batch's period of usability.

If only a document-based batch inspection is required, you will receive notification of the batch release and/or the EU certificate no later than 15 working days after receipt of the batch documentation.

You will receive the release faster if the batch has already been tested in the OMCL network and the release is recognized in Germany. In this case, you will receive notification of the batch release from the PEI no later than 7 working days after receipt of the batch.

• § 32, 33 Animal Vaccine Ordinance (TierImpfStV)
• § Section 52 (3) of the Veterinary Medicinal Products Act (TAMG)
• Articles 127, 128 Regulation (EU) 2019/6
• EU administrative procedure for batch testing of immunological veterinary medicinal products according to Article 128 of Regulation 2019/6

• Contradiction
  • Further information on how to lodge an objection can be found in the notification of your application.
• Appeal to the administrative court

Forms available: No

Written form required: Yes

Informal application possible: Yes

Personal appearance necessary: No

You can have your veterinary medicinal product tested by the PEI in parallel to your own testing as a pharmaceutical company in order to speed up the release procedure.

08.11.2022