In addition to OBPR, experimental testing of immunological veterinary medicinal products is another part of official batch release. This testing is based on Article 82 of the European Directive 2001/82 / EC (Community code relating to veterinary medicinal products).
It may be performed either by the Paul-Ehrlich-Institute (PEI) or a national control laboratory of another Member State of the European Union (EU), the European Economic Area (EEA) or Switzerland, which is part of the network of Official Medicines Control Laboratories (OMCL).
Experimental testing of immunological veterinary medicinal products will be carried out in accordance with jointly agreed guidelines and will be recognised by the other national control laboratories of the OMCL network.
For immunological veterinary medicinal products, there is a general guideline for official batch release based on the experimental testing by a control laboratory, the so-called Official Control Authority Batch Release (OCABR) guideline. The OCABR Guideline contains a list of immunological veterinary medicinal products to be subjected to experimental testing by a control laboratory. This list of veterinary medicinal products is coordinated with the EU / EEA Member States concerned and with Switzerland and the European Directorate for the Quality of Medicines (EDQM). In deciding whether a veterinary medicinal product is to undergo experimental testing for the purposes of the national batch release, the PEI will follow this OCABR guideline.
There are also specific guidelines applicable for the immunological veterinary medicinal products listed, the so-called VET OCABR guidelines (Veterinary Official Control Authority batch release). These product-specific guidelines define the experimental tests be performed by the control laboratory. PEI uses this OCABR guidance as a basis in deciding whether experimental tests should be performed on a veterinary medicinal product for the purpose of governmental batch release.
Requirements for the pharmaceutical company, specifying the information on batch production and testing that must be submitted with the application for batch release are contained in special model protocol templates of the EDQM for manufacturing and test protocols.
Step 1: The pharmaceutical company requests the release of a batch. This application shall be accompanied by the documents relating to the production and quality control of the batch and appropriate samples of the batch to be released.
Step 2: The samples are tested experimentally according to the respective OCABR guidelines in the official medicinal control laboratories at the PEI.
Step 3: The PEI decides on the release of the batch on the basis of the submitted batch documentation and the results of its own experimental testing of the test samples. The batch must meet the criteria and specifications as laid down in the approval for the Federal Republic of Germany.
Step 4: The notification of the state batch release will be issued no later than 60 days after receipt of the samples to be tested and complete batch documentation.
In principle, there is the possibility of parallel testing of a batch to be released by the pharmaceutical company and the PEI. This means that appropriate batch test samples can already be submitted to the PEI for internal testing before the internal release by the pharmaceutical company. This procedure serves to shorten the general duration of a release, which is advantageous for the pharmaceutical entrepreneur and has proven to be useful in the past.
If the batch is to be marketed in one or more member states of the EU / EEA or in Switzerland, the pharmaceutical company may apply for a so-called EU certificate from the PEI, provided that it has a marketing authorisation in Germany for this veterinary medicinal product.
If a batch has already been tested and approved by the competent authority of another EU / EEA or Switzerland Member State in accordance with the OCABR Guidelines, the relevant EU certificate as a confirmation of batch release shall be attached to the application for release and the batch documentation in this country. This certificate is recognised by the PEI and used as the basis for reviewing the documentation and deciding on batch release. If the batch complies with the specifications laid down in the marketing authorisation for the Federal Republic of Germany, the PEI will issue the notification of the official batch release within 7 working days.
The fees to be paid for the state batch test can be found in the Statutory Cost Regulation relating to vaccines for veterinary use (Tier-KostVO).
Application for Batch Testing
For immunological veterinary medicinal products, there are general guidelines on official batch release. For release based solely on Official Batch Protocol Review (OBPR) by a control laboratory, the so-called OBPR guideline applies, while for release including experimental testing at an Oficial Medicines Control Laboratory (OMCL), the Official Control Authority Batch Release (OCABR) guidelines are relevant. When deciding on the batch release the PEI complies with these guidelines.
How to Submit
The submission of documents is usually done electronically via the PEI-C Rebuild application.
Submission of Test Samples
Please send samples by mail to the Paul-Ehrlich-Institut (PEI) using the address indicated below.
The fees to be paid for the state batch testing can be found in the Animal Vaccine Cost Ordinance (Tier-KostVO).
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Section 4/3 – Product Testing of IVMP