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 |
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 |
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 |
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 |
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 |
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 |