Apply for batch release of immunomodulators as veterinary medicinal products

Service Description

Before you can make an immunological veterinary medicinal product batch available for the German market, it must be tested and approved. State batch testing for immunological veterinary medicinal products is carried out by the Paul Ehrlich Institute (PEI). If you would like to have an in-vitro diagnostic product approved and a batch released, you must submit a separate application to the Friedrich-Loeffler-Institut (FLI).

Immunological veterinary medicinal products that require batch release include

  • Immunomodulators
  • sera
  • vaccines
  • Tuberculins

How are the immunomodulators checked?

The PEI reviews your submitted batch documentation (Official Batch Protocol Review, OBPR) on the basis of the EU administrative procedure for batch verification of immunological veterinary medicinal products in accordance with Article 128 of Regulation (EU) 2019/6.

If your batch meets the criteria specified in the marketing authorization for your medicinal product, you will receive a national release decision and/or an EU certificate, if requested, by post from the PEI or you can retrieve both in PEI-C Rebuild.

What European standards are there?

Batch testing is regulated uniformly in the member states of the European Union (EU) and in Norway, Liechtenstein, Iceland and Switzerland. It is carried out according to the rules of the Official Medicines Control Laboratories (OMCL).

These laboratories have joined together to form a network under the direction of the European Directorate for the Quality of Medicines (EDQM). The Paul-Ehrlich-Institut (PEI) is represented in the OMCL network as a state control laboratory.

If your batch has already been released by a laboratory in the OMCL network, it will be recognized and therefore also released more quickly in Germany. If you would like to distribute your batches from Germany to other countries in the OMCL network, you can apply for an EU certificate from the PEI for this purpose.

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

Start your request directly online:

Competent Authority

Paul-Ehrlich-Institut (PEI), PEI-C Rebuild

Further Authorities

Paul-Ehrlich-Institut (PEI), Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Abteilung Veterinärmedizin
Address
Paul-Ehrlich-Straße 51-59
63225 Langen (Hessen)
Telephone
+49 6103 770
Remark: PEI Head Office
Fax
+49 6103 771234