Quality control of immunological veterinary medicinal products in Europe
and
Dec 19, 2019
About this article
Article Category: Review article
Published Online: Dec 19, 2019
Page range: 587 - 595
Received: Jul 22, 2019
Accepted: Nov 28, 2019
DOI: https://doi.org/10.2478/jvetres-2019-0075
Keywords
© 2019 K. Pasik, E. Łysiak et al. published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.
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Objectives of GEON
| 1 | Mutual recognition (in UE) of tests performed by OMCLs at the national level |
| 2 | Increase of communication among the OMCLs ( |
| 3 | Harmonisation of working methods ( |
| 4 | Coordination of OMCLs work ( |
| 5 | Exchange of information |
| 8 | Cooperation with other institutions in the world |
| 9 | Promotion of the development of harmonised standards |
| 10 | Elaboration of reference substances and preparations |
OMCLs within the Veterinary Batch Release Network able to provide OCABR Certificates (list updated 07/09/2018)
| No. | Country | Name of OMCL |
|---|---|---|
| 1 | Belgium | Veterinary and Agrochemical Research Centre (CODA-CERVA) |
| 2 | Czech Republic | Institute for State Control of Veterinary Biologicals and Medicines |
| 3 | Finland | Finnish Food Safety Authority, Evira |
| 4 | France | French National Agency for Veterinary Medicinal Products (Anses-ANMV) |
| 5 | Germany | Paul-Ehrlich-Institut (PEI) |
| 6 | Hungary | National Food Chain Safety Office, Directorate for Veterinary Medicinal Products, Immunological Department Biological Laboratory |
| 7 | Poland | National Veterinary Research Institute |
| 8 | Romania | Institute for Control of Veterinary Biological Products and Medicines |
| 9 | Slovak Republic | Institute for State Control of Veterinary Biologicals and Medicaments |
| 10 | Switzerland | Institute of Virology and Immunology |
Results of PMS studies between 2010 and 2018
| Year | Number of samples of IVMPs tested | Non-conformity of the leaflet/package | Non-conformity of test results |
|---|---|---|---|
| 2010 | 18 | 8 | 0 |
| 2011 | 12 | 15 | 0 |
| 2012 | 29 | 30 | 2 |
| 2013 | 35 | 19 | 5 |
| 2014 | 36 | 1 | 1 |
| 2015 | 42 | 5 | 2 |
| 2016 | 46 | 19 | 0 |
| 2017 | 50 | 15 | 1 |
| 2018 | 47 | 12 | 1 |
Objectives of the OMCL
| 1 | Quality control of medicinal products before and after placing on the market |
| 2 | Protection of public and animal health |
| 3 | Expert assessment in the evaluation of the qualitative part of the registration dossier regarding the admission of medicinal products to the market |
| 4 | Analysis of drugs used illegally or falsified drugs |
| 5 | Pharmacovigilance support |
| 6 | GMP inspection support |
| 7 | Participation in the development of the European Pharmacopoeia, monographs and/or general chapters and methods and the elaboration of reference standards |
| 8 | Participation in the Biological Standardisation Programme |
| 9 | Research carried out as part of cooperation with OMCL |
Objectives of the EDQM
| 1 | Protection of public health |
| 2 | Introduction of European Pharmacopoeia quality standards |
| 3 | Surveillance, controlling of medicines – centrally authorised products (CAP) sampling, market surveillance studies (MSS), active pharmaceutical ingredients (APIs) |
| 4 | Assurance of quality of blood transfusion and transplantation products |
| 5 | Assurance of quality of cosmetics and food-contact materials |
The number of batch release certificates for IVMPs issued by NVRI between 2010 and 2018
| Year | Number of certificates for IVMPs |
|---|---|
| 2010 | 1,334 |
| 2011 | 1,260 |
| 2012 | 1,518 |
| 2013 | 1,424 |
| 2014 | 1,444 |
| 2015 | 1,542 |
| 2016 | 1,660 |
| 2017 | 1,685 |
| 2018 | 1,932 |