This unit is considered as the Belgian Expertise Center for the Quality of Immunological Medicines for Veterinary Use (IVMP or Immunological Veterinary Medicinal Product). This includes vaccines but also colostrum replacements, anti-serum and other veterinary medicines with an immunological mode of action. Whenever you read "vaccine" in this text below, it implies IVMP.
This unit has been appointed by the Federal Medicines Agency (FAGG/AFMPS) as Official Medicines Control Laboratory (OMCL) and is recognized as such by the European Directorate for the Quality of Medicines (EDQM).
An OMCL controls the quality of vaccines in several ways. Each batch (production-lot) of a medicine must have a "passport" (BRP or Batch Release Protocol) that describes the details of its proper production process. This includes for example the vaccine specific strain(s), the Critical Control Points, production timeline with dates and testing results. This document must be signed by the QP of the company taking responsibility for that batch.
Before a batch of vaccine can be marketed in Belgium, it must be controlled by an OMCL (Belgian or other EU member state).
This can be an administrative control or it can include retesting of some specific parameters. If the batch proves to be compliant to the specifications that are determined in the Marketing Authorisation dossier, the OMCL provides a certificate that can be used throughout the EU.
If only an administrative control has been performed, an OBPR certificate will be provided (Official Batch Protocol Review). Vaccines that have undergone retesting by the OMCL as well as an administrative control, will lead to an OCABR certificate (Official Control Authority Batch release).
Batches of vaccines that have received an OBPR or OCABR certificate and will be marketed in Belgium require an additional step. The following information must be provided: Batch Release Protocol (BRP), number of vials, pictures of packaging and the relevant OBPR/OCABR certificate. This will be checked by our unit and if conform, a Marketing Information Form (MIF) will be provided. With this MIF-certificate the relevant batch can be brought to the Belgian Market.
More practical information with regards to batch release can be found on the following page
Additionally, our unit works in close collaboration with the Medicines Agency on the Quality of veterinary vaccines (IVMPs).
We are for example part of the GMP inspections in (Belgian) IVMP production facilities; we evaluate the part II (Quality) of dossiers to obtain a Marketing Authorisation including variations of the existing Marketing Authorisations and we are involved in the evaluation of derogations.
We also perform post-marketing testing (requested by the Medicines Agency as well as EMA). This means that batches of vaccines that are already on the Belgian or European Market can be sampled and tested. The same criteria apply here: the vaccine must comply with the specifications that are registered in the existing Marketing Authorisation.
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