Alongside protocol review, the experimental testing of immunological veterinary medicinal products is another key component of official batch testing. Experimental testing is based on both Article 128 and Article 127 of European Regulation (EU) 2019/6 on veterinary medicinal products.
It can be carried out either by the Paul-Ehrlich-Institut (PEI) or by a state control laboratory in another Member State of the European Union (EU), the European Economic Area (EEA) or Switzerland that is part of the network of Official Medicines Control Laboratories (OMCL).
The experimental testing of immunological veterinary medicinal products is carried out in accordance with jointly established guidelines and is accordingly recognised by the other state control laboratories in the OMCL network.
A general guideline is in place for state batch release of immunological veterinary medicinal products based on experimental testing of by a control laboratory, called the OCABR guideline (Official Control Authority Batch Release). The OCABR guideline contains a list of immunological veterinary medicinal products that must be subjected to experimental testing by a control laboratory. This list of veterinary medicinal products is maintained in coordination with the relevant Member States of the EU/EEA, Switzerland, and the European Directorate for the Quality of Medicines & HealthCare (EDQM). The Paul-Ehrlich-Institut follows the OCABR guideline when issuing decisions as to whether a veterinary medicinal product must be subjected to experimental tests for official batch release.
Specific guidelines known as the VET OCABR guidelines (Veterinary Official Control Authority Batch Release) also apply to the listed immunological veterinary medicinal products. These product-specific guidelines contain specifications as to which experimental tests must be carried out by the control laboratory. The Paul-Ehrlich-Institut uses the VET OCABR guidelines as a basis for its decisions on which experimental tests a veterinary medicinal product must be subjected to for federal batch release.
Requirements for pharmaceutical companies that specify the information, manufacturing documents, and batch control documents that must be submitted with the batch testing application are listed in special EDQM templates for the manufacturing and testing protocols (model protocol templates).
Step 1: The pharmaceutical company requests the release of a batch. This application must be accompanied by the batch manufacturing and quality control documents as well as corresponding test samples of the batch to be released.
Step 2: The test samples are subjected to the experimental tests specified in the OCABR guidelines in the official testing laboratories of the Paul-Ehrlich-Institut.
Step 3: The Paul-Ehrlich-Institut decides on the release of the batch based on the batch documentation that was submitted and the results of its own experimental testing of the test samples. The batch must comply with the criteria and specifications as set out in the marketing authorisation in order to be released.
Step 4: The decision on the official batch release will be issued no later than 60 days after the samples to be tested and the complete batch documentation have been received if the batch passes the test.
Parallel testing by the pharmaceutical company and the Paul-Ehrlich-Institut of a batch to be released is possible. In this case, corresponding batch test samples can be submitted to the Paul-Ehrlich-Institut for experimental testing even before internal approval by the pharmaceutical company. This procedure serves to shorten the general duration of the release process, which is advantageous for the pharmaceutical entrepreneur and has proven to be useful in the past.
If the batch is to be distributed in one or more Member States of the EU/EEA or in Switzerland, the pharmaceutical company may apply to the Paul-Ehrlich-Institut for a document called an EU certificate, provided that the company has a marketing authorisation in Germany for the veterinary medicinal product.
If a batch has already been tested and released by the competent authority of another Member State of the EU/EEA or Switzerland in accordance with the OCABR guidelines, the application for release and the batch documentation must be accompanied by the corresponding EU certificate as proof of the batch release in that state. This certificate is recognised by the Paul-Ehrlich-Institut upon review of the application and is used as a basis for the examination of the documentation and decision on the batch release. If the batch complies with the specifications as set out in the marketing authorisation for the Federal Republic of Germany, the Paul-Ehrlich-Institut will issue a decision on the official batch release within seven working days.
If another batch has already been released by the Paul-Ehrlich-Institut that differs from the batch to be released only in the batch name, volume, or the name of the medicinal product, an application for a reference batch submission can be made. If the batch complies with these conditions, the Paul-Ehrlich-Institut will issue a decision on the official batch release and, if applicable, an EU certificate within seven days.
The fees to be paid for official batch testing can be found in the Special Fee Ordinance of the Federal Ministry of Food and Agriculture (BMELBGebV, section 15, subsection 2).
Updated: 07.11.2025
