Independent analysis, the guarantee of vaccines and blood products of impeccable quality
Our service is recognised by the Federal Agency for Medicines and Health Products (FAMHP) as the Official Medicines Control Laboratory (OMCL) for biological medicinal products for human and veterinary use. It is also recognised as such by the European Directorate for the Quality of Medicines & Health Care (EDQM).
Each batch, whether human or veterinary, must be controlled by an OMCL (in Belgium or any other Member State of the EU) before it is placed on the market. The batch must comply with the approved specifications provided for in the monographs of the European Pharmacopoeia and the marketing authorisation file concerned. Our service then issues a batch release certificate to the manufacturer.
We also work closely with the FAMHP. We provide expert opinions during licensing and scientific opinion procedures, provide post-market surveillance, and participate in “Good Manufacturing Practice” inspections of pharmaceutical companies as technical expert.
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In Europe, unlike other medicines, vaccines and blood products must be controlled by an OMCL before they are placed on the market, irrespective of the producers. Each batch is analysed in the laboratory using methods validated and implemented under quality assurance (ISO17025). After demonstrating the efficacy, safety and quality of the product, the manufacturer submits each batch to the competent authority for control and document review.
This procedure is known by the acronym: OCABR procedure (Official Control Authority Batch Release procedure). For certain veterinary products, only a documentary review is provided for according to the OBPR (Official Batch Protocol Review) procedure.
On the other hand, for countries outside Europe we issue a release certificate following the review of the protocol data submitted by the producer.
In order to be able to market in Belgium products that have already received an OBPR/OCABR certificate from a European OMCL, the manufacturer must submit a MIF form (Marketing Information Form) to the Belgian OMCL, together with a certificate of entry into circulation. After examination, the batches will be validated but for the Belgian market only.
We also act as an expert in the field of human and veterinary vaccines, as well as for blood products.
We assess the “quality” part of registration files, variations and scientific opinions and participate in controls of “good manufacturing practices” among vaccine producers and blood establishments (blood sampling and testing) certified in Belgium.
We participate in opinion groups and contribute to the drafting of regulatory texts in these matters at Belgian level at the request of the Federal Agency for Medicines and Health Products (FAMHP) and the Superior Health Council (HSC). At international level, we thus issue expert opinions to the European Medicines Agency (EMA), the EDQM and the World Health Organization (WHO).
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Requesting a review, analysis or batch release
We are responsible for the release of batches of blood products, for tests as well as for requests for expertise.