There are a number of partners involved with the European Medicines Agency in the Sampling and Testing activity.
Rapporteurs and Co-Rapporteurs
Before receiving a marketing authorisation, each medicine goes through a process of evaluation; this process is led by a Rapporteur and a Co-Rapporteur, two of the experts that sit on the CHMP (for human medicines) or on the CVMP (for veterinary medicines). The Rapporteur and the Co-Rapporteur play a crucial role in the whole sampling and testing exercise. They are requested to provide their recommendations on the tests that they consider act as indicator of the quality of the product, and that will be performed by the testing laboratories. At the end of the programme the Rapporteurs and Co-Rapporteurs will receive from the European Medicines Agency copies of the individual product reports issued by EDQM. On the basis of the content of these reports, the Rapporteur and the Co-Rapporteur will advise the European Medicines Agency on the follow-up actions to be taken on the issues highlighted (if any) in the report.
European Directorate for the Quality of Medicines (EDQM) Council of Europe
EDQM is the body that co-ordinates the work of the national competent authorities and of the Official Medicines Control Laboratories (OMCLs) for the sampling and testing of the products. At the beginning of each programme, on the basis of the information collected (products to be tested, marketing status, tests recommended by the Rapporteurs and Co-Rapporteurs, products specifications and test procedures provided by the MAHs), EDQM prepares the sampling and testing plan. EDQM then co-ordinates sampling of the medicines from the markets (carried out by the national authorities’ inspection services) and their testing (carried out by the laboratories of the EU/EEA OMCLs network). On the basis of the test reports from the different OMCLs, EDQM prepares and provides the European Medicines Agency with individual product reports and summary sheetsfor each product tested.
EEA OMCLs network
It is a network of Official Control Laboratories formed by laboratories of EU/EEA Member States. It is part of the wider OMCLs network established in the mid-90s under the aegis of the Council of Europe. The task of the laboratories is the testing of samples of medicinal products, to check whether they comply with the specifications laid down in the marketing authorisation. They report to EDQM about the outcomes of the tests, including any problems met during the testing, and any ‘out of specification’ results.
The National Authorities provide personnel from their Inspection Services, who carry out the sampling from the national markets, and participate in the testing programme with their OMCL capacities (see above).
Marketing Authorisation Holders
The companies contribute to the positive outcome of the Programmes by providing, at request of the European Medicines Agency, the relevant information from the original applications, as amended; tests methods and specifications of the products; samples from a single batch (to be used as Common Test Sample by the laboratories); reference materials and reagents; information on the marketing status of the products. At the end of the exercise, the MAHs receive a copy of the testing results of their product(s).
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