EU Certificate (Veterinary)
Swiss Member States, the pharmaceutical entrepreneur may apply to the PEI for official batch release including the issuance of a so-called EU certificate, provided the company owns a marketing authorisation for that veterinary medicinal product in Germany.
Control of these veterinary medicinal products will be carried out in accordance with the procedures and regulations of the Network of Official Medicines Control Laboratories (OMCL) in the EU, as set out in the respective guidelines.
If the batch protocol review or experimental testing indicates that the criteria set out in the authorisation of the veterinary medicinal product have been met, the PEI shall issue a so-called EU certificate. With this certificate, the pharmaceutical entrepreneur can apply for the acceptance of batch release in another Member State of the OMCL network.
Such an EU certificate can also be requested from the PEI before a national batch release or after a successful national batch release.
The requirements for state batch testing of immunological veterinary medicinal products are set out in the so-called Official Batch Protocol Review (OBPR) or the Official Control Authority Batch Release (OCABR) guidelines.
The specifications regarding the information and documents for the production and control of the batches, which must be submitted with the application for batch testing by the pharmaceutical company, are contained in special format templates for the production and test protocols (model protocol template).
For immunological veterinary medicinal products that are not approved in Germany, the Paul-Ehrlich-Institut (PEI) offers to create a test report on a private law basis. For a test report, the same experimental tests as for official batch control or additional tests can be carried out. The nature and extent of the tests and examinations to be carried out should always be clarified in advance.
Test reports of the PEI are accepted by many states, e.g. outside the EU as a sufficient prerequsite for the marketing of an immunological veterinary medicinal product. However, a 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 state.
A test report can only be issued after conclusion of a private law contract. This individual contract between the pharmaceutical company and PEI determines the nature and extent of the experimental testing, the volume of batches to be tested, the number of test samples to be submitted and the documentation on manufacture of the product to be tested.
The fees to be paid for the preparation of test reports are negotiated individually with the pharmaceutical entrepreneur and are usually based on the type and extent of the examinations to be performed by the PEI.