Fig. 1
Diagram of the authorisation and introduction of a medicinal product in the European Union
Table 1
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 |
Table 2
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 |
Table 3
Objectives of GEON
| 1 | Mutual recognition (in UE) of tests performed by OMCLs at the national level |
| 2 | Increase of communication among the OMCLs (e.g. handbooks, databases), work sharing |
| 3 | Harmonisation of working methods (e.g. quality management system, proficiency testing programme, audits) |
| 4 | Coordination of OMCLs work (e.g. collaborative studies on the validation of methods) |
| 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 |
Table 4
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 |
Fig. 2
Batch release control scheme
Table 5
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 |
Fig. 3
The most frequently performed quality tests of IVMPs in PMS 2010–2018
Fig. 4
Percentage of vaccines for different animal species evaluated during PMS studies in 2018
Fig. 5
Percentage of vaccines for selected animals species on the Polish market in 2018