<abstract xmlns="http://www.w3.org/1999/xhtml">

<p>Medicinal products in Europe are under the strict control of many organisations headed by the European Directorate for the Quality of Medicines and HealthCare (EDQM) in Strasbourg and its related General European Official Medicines Control Laboratories (OMCLs) Network (GEON). The EDQM works in cooperation with the European Medicines Agency (EMA) and the World Health Organisation (WHO). All of these institutions have one main goal – to protect public health in Europe and around the world. One of the more important effects of the harmonisation of pharmaceutical law in Europe was the introduction of the mutual recognition principle for the Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) certificates in the European Union. The National Veterinary Research Institute (NVRI) in Poland is an example of an OMCL laboratory within the Veterinary Batch Release Network (VBRN) that issues the European certificates. The NVRI is actively involved in the batch release of immunological veterinary medicinal products (IVMPs), with approximately 1,800 certificates for IVMPs issued per year. It is also one of only four veterinary OMCLs that perform Post Marketing Surveillance (PMS) studies including approximately 47 IVMPs per year. All the results of the testing data are sent to the Chief Veterinary Officer, and also to the electronic Network platforms of the EDQM, which enables transparent information exchange.</p>
</abstract>

Medicinal products in Europe are under the strict control of many organisations headed by the European Directorate for the Quality of Medicines and HealthCare (EDQM) in Strasbourg and its related General European Official Medicines Control Laboratories (OMCLs) Network (GEON). The EDQM works in cooperation with the European Medicines Agency (EMA) and the World Health Organisation (WHO). All of these institutions have one main goal – to protect public health in Europe and around the world. One of the more important effects of the harmonisation of pharmaceutical law in Europe was the introduction of the mutual recognition principle for the Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) certificates in the European Union. The National Veterinary Research Institute (NVRI) in Poland is an example of an OMCL laboratory within the Veterinary Batch Release Network (VBRN) that issues the European certificates. The NVRI is actively involved in the batch release of immunological veterinary medicinal products (IVMPs), with approximately 1,800 certificates for IVMPs issued per year. It is also one of only four veterinary OMCLs that perform Post Marketing Surveillance (PMS) studies including approximately 47 IVMPs per year. All the results of the testing data are sent to the Chief Veterinary Officer, and also to the electronic Network platforms of the EDQM, which enables transparent information exchange.

Quality control of immunological veterinary medicinal products in Europe

Journal of Veterinary Research

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

{"article-title":"Quality control of immunological veterinary medicinal products in Europe"}

Medicinal products in Europe are under the strict control of many organisations headed by the European Directorate for the Quality of Medicines and HealthCare...

Quality control of immunological veterinary medicinal products in Europe

Article Category: Review article

Pubblicato online: 19 dic 2019

Pagine: 587 - 595

Ricevuto: 22 lug 2019

Accettato: 28 nov 2019

DOI: https://doi.org/10.2478/jvetres-2019-0075

Parole chiave
EDQM, EMA, OMCL, GEON, National Veterinary Research Institute, Poland

© 2019 K. Pasik, E. Łysiak et al. published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Quality control of immunological veterinary medicinal products in Europe

Article Category: Review article

Pubblicato online: 19 dic 2019

Pagine: 587 - 595

Ricevuto: 22 lug 2019

Accettato: 28 nov 2019

DOI: https://doi.org/10.2478/jvetres-2019-0075

Parole chiaveEDQM, EMA, OMCL, GEON, National Veterinary Research Institute, Poland

© 2019 K. Pasik, E. Łysiak et al. published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Parole chiave
EDQM, EMA, OMCL, GEON, National Veterinary Research Institute, Poland