Within the EU/EEA OMCL Network, a voluntary post-marketing surveillance scheme has been set up for medicinal products having received a marketing authorisation via the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP).
The main purpose of this scheme is to improve the surveillance of MRP/DCP-products placed on the EU/EEA market through two principles:
- work sharing with the aim of optimal and cost-effective use of analytical resources;
- sharing test results with the OMCL Network and also with other bodies concerned (e.g. Heads of Medicines Agencies, European Medicines Agency).
- The procedure
- Benefits of the MRP/DCP Post-Marketing Surveillance Scheme
- MRP/DCP Product Testing Scheme: Achievements 2020
Since the early 2000s, post-marketing surveillance activities for products authorised through the Mutual Recognition Procedure (MRP) and as of 2005 also for those following the Decentralised Procedure (DCP), including generic medicines, have been performed on a voluntary basis by members of the General European OMCL Network from EU/EEA member states coordinated by the EDQM, the Network's secretariat. The programme is based on the principles of work sharing and sharing of test results. Both are possible because the MRP and DCP enable marketing authorisation (MA) of a medicinal product in more than one EU/EEA member state, and because all OMCLs apply the same quality standard and are externally audited on a regular basis.
A position paper, “History, results and benefits of testing MRP/DCP products (PA/PH/OMCL (12) 57 R4”, was originally released in July 2013. Please download the document via the right-hand menu. This document underlines the value of this concerted Network activity and also includes a statistical evaluation of the scheme, as well as an outlook on future perspectives. With this programme manifold gain for EU/EEA countries is achieved with respect to coverage of MRP- and DCP-products by testing. In the current situation, this means that taking into account all finalised projects reported in the database, by testing one product an average participating member state benefits from the scheme by receiving the testing results for 9 marketed products generated by other member states.
The 16th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out in 2020. Around 1100 product testing projects were allocated to this programme, which represents a slight decrease. This decrease could be related to the COVID-19 pandemic. The crisis has led to changes in the planning and resetting of priorities of the laboratories. The test reports came from 23 different OMCLs.
The medicines tested in 2020 most frequently contained the following active pharmaceutical ingredients (APIs): sildenafil (treatment of erectile dysfunction), rosuvastatin and atorvastatin (treatment of hypercholesterolaemia), pregabalin (anticonvulsant and anxiolytic), estradiol (hormone replacement), amlodipine (treatment of hypertension and angina pectoris), enrofloxacin (antibiotic), ezetimibe (treatment of hypercholesterolaemia), indapamide (treatment of hypertension and decompensated heart failure). Around 1% of samples tested in the programme originated from a member state or an OMCL that was not involved in the testing (sent by another OMCL). These efforts of the OMCLs to include samples from other member states in their national testing programmes, and the sharing of all testing results with the entire Network, demonstrates the added value of the surveillance scheme with respect to work sharing.
For around 3,4% of the tested materials, regulatory issues were identified, in 1,5% of cases one or more out-of-specification results were reported and 0,6% of serious finding were found. Some 11% of the tested products were intended for veterinary use. Since 2012, more DCP- than MRP-products have been included in the annual programmes.
By end of December 2020 more than 13 300 records were available in the database with contributions from 36 OMCLs.