If an immunological veterinary medicinal product is to be distributed in one or more Member States of the EU, the EEA, or in Switzerland, the pharmaceutical company may also apply to the Paul-Ehrlich-Institut for official batch testing including the issuance of a document called an EU certificate, provided that the company has a marketing authorisation valid in Germany for the veterinary medicinal product.

The testing of these veterinary medicinal products is carried out in accordance with the procedures and regulations of the Network of Official Medicines Control Laboratories in the EU (OMCL), as set out in the relevant guidelines.

If the examination of the batch documentation or the experimental testing shows that the criteria laid down in the marketing authorisation of the veterinary medicinal product have been met, the Paul-Ehrlich-Institut will draw up an EU certificate and, if experimental testing has been carried out, an OCABR test report (Official Control Authority Batch Release). The pharmaceutical company can use the OCABR test report to apply for recognition of the official batch testing in another member state of the OMCL network.

An application for an EU certificate can also be submitted to the Paul-Ehrlich-Institut before or after a national batch release.

Document Requirements

The requirements for the official batch testing of immunological veterinary medicinal products are laid down in the OCABR/OBPR guideline (Official Control Authority Batch Release/Official Batch Protocol Review, EU Administrative Procedure for Official Batch Release of Immunological Veterinary Medicinal Products in Application of Article 128 of Regulation (EU) 2019/6).

The requirements regarding the information, manufacturing documents, and batch control documents that must be submitted with the batch testing application by the pharmaceutical company 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).

For immunological veterinary medicinal products that are not authorised in Germany, the Paul-Ehrlich-Institut can produce a test report based on private law. A test report can include the same experimental tests used for official batch testing as well as additional tests. The nature and scope of the tests and examinations to be carried out should be clarified in advance.

Test reports from the Paul-Ehrlich-Institut are regarded by many countries, such as those outside the EU, as a sufficient prerequisite for the marketing of an immunological veterinary medicinal product. However, clarification of the recognition of test reports and the concrete contents of these reports should be brought about in advance with the authorities of the respective country.

A test report can only be issued after the conclusion of a contract under private law. This individual contract between the pharmaceutical company and the Paul-Ehrlich-Institut determines the nature and scope of the experimental tests, the scope of the batches to be tested, the number of test samples to be submitted, and the required manufacturing documentation for the product to be tested.

Costs

The fees due for the preparation of test reports are negotiated individually with the pharmaceutical company and are usually based on the nature and scope of the tests to be carried out by the Paul-Ehrlich-Institut.