In addition to experimental testing for official batch release in Germany, the Paul-Ehrlich-Institut (PEI) also carries out testing in connection with the issuing of certificates or test reports:
- EU certificates
- Test reports
- WHO certificates
If a biological medicinal product (a product manufactured from blood plasma, immunoglobulin, vaccine) is to be distributed in one or more member states of the European Union (EU) or European Economic Area (EEA), the pharmaceutical company may apply for official batch testing of it by the Paul-Ehrlich-Institut (PEI) in accordance with Article 114 of European directive 2001/83/EC, insofar as the company is the holder of a marketing authorisation for the medicinal product in Germany. The experimental testing of the medicinal products takes place in accordance with the procedures and regulations of the network of the Official Medicines Control Laboratories in the EU (OMCL network).
If the experimental testing and the checking of the submitted documents show that the criteria defined in the marketing authorisation of the medicinal product have been met, the PEI will issue an “EU certificate”. With this certificate, the pharmaceutical company can apply for the recognition of the official batch testing in another member state of the OMCL network.
An EU certificate may also be applied for even after national batch release has taken place.
Requirements on the Documents
The requirements for the experimental batch testing of biological medicinal products are defined in the OCABR (Official Control Authority Batch Release) guidelines. They describe which information and documents on manufacture and batch control should be submitted with the application for batch testing.
The Paul-Ehrlich-Institut (PEI) can draw up, on a private contract basis, a “test report” for medicinal products that have not been authorised in Germany or in the member states of the European Union (EU). In general, the same experimental tests are carried out for a test report as for official batch testing. Test reports can, however, only describe a single experimental test.
Test reports from the PEI are regarded by many states outside the EU as a sufficient prerequisite for the marketing of the medicinal product in that country. It is, however, essential to hold preliminary discussions with the authorities in the country in question in order to clarify the recognition of test reports and their actual contents.
In general, a test report may only be issued after a private contract has been concluded. This individual contract between the pharmaceutical company and the PEI defines the scope of the batches to be tested, the number of test samples to be submitted and the documentation required with regard to the manufacture of the product.
The fees payable for the issuing of test reports are negotiated individually with the pharmaceutical company and are generally determined by the scope and nature of the tests to be carried out by the PEI.
Federal Institute for Vaccines and Biomedicines
The Paul-Ehrlich-Institut (PEI) issues two types of certificates:
• Certificate of a Pharmaceutical Product (CPP)
• Batch Certificate of a Pharmaceutical Product (BCPP)
BCPP (Batch Certificate of a Pharmaceutical Product)
A batch certificate (BCPP) accompanies a specific batch of a medicinal product. It confirms its quality and other batch attributes (e.g. expiry date). In general, it is issued by the medicinal product manufacturer.
In the case of medicinal products which are subject to mandatory official batch testing in Germany, BCPPs are issued by the Paul-Ehrlich-Institut. In the case of medicinal products exported to third countries, these certificates are essentially used to prove that the medicinal products comply with the “WHO guidelines for the manufacture of medicinal products and the assurance of their quality”. In terms of their content, the “WHO guidelines” correspond to the European regulations on Good Manufacturing Practice (GMP) for medicinal products.
Applications are submitted to the PEI by e-mail using the BCPP form or via the PEI-C Rebuild portal.