The review of batch documentation or the manufacturing and quality control documentation for an immunological veterinary medicinal product (Official Batch Protocol Review, OBPR) is based on Article 128 in conjunction with Article 127 of European Regulation (EU) 2019/6 on veterinary medicinal products. This review is part of the official batch testing for all immunological 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) in accordance with jointly defined guidelines. The result of the batch documentation review is accordingly recognised by the other state control laboratories in the OMCL network.
Requirements for pharmaceutical companies that determine which batch manufacturing and control information must be submitted as batch documentation with the batch testing application are contained in special templates created by the European Directorate for the Quality of Medicines and HealthCare (EDQM) for the production and test 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.
Step 2: If experimental testing of the requested immunological veterinary medicinal product is not necessary, the Paul-Ehrlich-Institut issues a decision on the batch release based on the batch documentation that was submitted. The batch must comply with the criteria and specifications as set out in the marketing authorisation for the Federal Republic of Germany in order to be released.
Step 3: The decision on the official batch release is issued no later than 15 working days after receipt of the complete batch documentation.
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 valid marketing authorisation in Germany for the immunological 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 OBPR or OCABR guidelines, the application for release and the batch documentation must be accompanied by a 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.
Test samples of the batch to be released should be submitted with each batch release application, even if the samples are only submitted as a prerequisite for official batch release (in the case of experimental testing) or in individual cases at the special request of the Paul-Ehrlich-Institut. This generally free provision of batch samples offers the Paul-Ehrlich-Institut the possibility of carrying out additional quality assurance product testing on a case-by-case basis. The Paul-Ehrlich-Institut intends to continue to carry out random experimental checks on its own regardless of the official batch release status. The continuous methodological comparison and precise information regarding the batches of a particular product have proven themselves useful in the past when problems arise and have been advantageous for all parties concerned with safety and costs. In such cases the quality of a batch could be demonstrated within the testing period by testing the reserve samples stored at the Paul-Ehrlich-Institut and any necessary measures could be limited to measures of the mildest extent.
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).
Email: veterinaermedizin@pei.de
Updated: 07.11.2025
