Applying for batch release of vaccines as veterinary medicinal products
Source: BUS Rheinland-PfalzBefore 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
- Vaccines
- sera
- immunomodulators
- Tuberculins
How are the vaccines checked?
The PEI first reviews your submitted documentation on the batch (Official Batch Protocol Review, OBPR). For certain vaccines, this is followed by an experimental batch review of the batches you have submitted (test samples).
Whether the PEI only reviews your documentation or also carries out an experimental batch review is decided after a risk assessment based on the EU administrative procedure for the batch review of immunological veterinary medicinal products in accordance with Article 128 of Regulation (EU) 2019/6. Among other things, the following are taken into account
- the potential risks of the product for human and animal health
- the requirements for combating animal diseases
- the product characteristics of the vaccine
- the risk-benefit assessment
The risk assessment of the competent authority is based on the European guidelines for batch testing (Official Control Authority Batch Release, OCABR Guidelines).
If your batch meets the criteria laid down in the marketing authorization for your medicinal product, you will receive a national release notice 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.