MRP/DCP Post Marketing Surveillance Scheme
The main purpose of this scheme is to improve the surveillance of MRP/DCP-products placed on the EU/EEA market through two principles:
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work sharing with the aim of optimal and cost-effective use of analytical resources;
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sharing test results with the OMCL Network and with other bodies concerned (e.g. Heads of Medicines Agencies, European Medicines Agency).
- Background
- The procedure
- Benefits of the MRP/DCP Post-Marketing Surveillance Scheme
- MRP/DCP Product Testing Scheme: Achievements 2023
Background
Since the early 2000s – initially for products authorised through the Mutual Recognition Procedure (MRP) and then, as of 2005, for those (including generic medicines) following the Decentralised Procedure (DCP) – post-marketing surveillance activities have been performed on a voluntary basis by members of the General European OMCL Network from EU/EEA member states. This programme is co-ordinated by the EDQM, the Network's secretariat, and 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 – ISO/IEC 17025 – and are externally audited on a regular basis.
The procedure
A complete description of this scheme's procedure can be found in "Co-operation in post-marketing surveillance of Mutual Recognition/Decentralised Procedure Products".
The document can also be accessed via the right hand menu.
Benefits of the MRP/DCP Post-Marketing Surveillance Scheme
A position paper, “Benefits of testing MRP/DCP products”, underlining the value of this concerted Network activity was first released in July 2013. The paper includes a statistical evaluation of the scheme, as well as an outlook on future perspectives. This programme has multiple benefits for EU/EEA countries with respect to coverage of MRP- and DCP-products by testing. Today, taking into account all finalised projects reported in the database, this means that, on average, a member state taking part in the scheme and testing one product will have access to the test results for nine marketed products generated by other member states.
The document can also be accessed via the right hand menu.
MRP/DCP Product Testing Scheme: Achievements 2023
The 19th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out in 2023 and covered about 1300 finalised product testing projects. The test reports were issued by 25 different OMCLs.
The medicines tested in 2023 most frequently contained the following active pharmaceutical ingredients (APIs): rosuvastatin (treatment of hypercholesteraemia), amlodipine (treatment of hypertension and angina pectoris), levothyroxine sodium (treatment of hypothyroidism), ramipril (treatment of hypertension), atorvastatin (treatment of hypercholesteraemia), bisoprolol (treatment of hypertension), olanzapine (treatment of psychotic conditions) and etoricoxib (anti-inflammatory).
A small number 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 test results with the entire Network is in line with the principles of this programme and the key objectives of the OMCL Network in general.
Regulatory issues were identified for around 0.5% of the tested materials; in 3.4% of cases, one or more out-of-specification results were reported. Some 15% 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 2023, more than 17 800 records were available in the database, with contributions from 37 OMCLs from the EU/EEA Network.
The EDQM’s co-ordination activities with respect to the MRP/DCP Programme are ISO 9001 certified by AFNOR Certification and audited on a regular basis.