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Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP) Post-Marketing Surveillance Scheme
These activities involve the EU/EEA OMCL Network only.
Background
Post-Marketing Surveillance of Mutual Recognition Procedure (MRP) Products
The end of 2000 saw the creation of a new testing scheme focusing on post-marketing surveillance of Mutual Recognition Procedure (MRP) products, which includes generic medicines. This scheme was initiated on a voluntary basis by members of the General European OMCL Network from EU/EEA Member States and the EDQM, the Network's secretariat. The participants are known as the testing group. After a 4-year trial period, it was decided, in May 2005, to continue with an annual work programme. Since, this scheme has regularly been followed by approximately 20 OMCLs from 12-15 member states. It is based on the principles of work-sharing and sharing of test results. Both are possible because the MRP enables marketing authorisation (MA) of a medicinal product in more than one EU/EEA Member State. To guarantee communication among participating OMCLs, the EDQM has installed an IT share point. By avoiding duplicate testing of the same product in different member states, the scheme provides a coordinated and cost savings approach to post-marketing surveillance. Currently, about 500 medicinal products are tested for quality per year within this programme.
Post-Marketing Surveillance of Decentralised Procedure (DCP) Products
A new challenge for the testing group was the implementation of a new community marketing authorisation procedure, the decentralised procedure (DCP), in force since October 2005. This was the end of the transition period for the ratification of the relevant European Parliament and Council Directives (i.e. Directive 2001/83/EC relating to medicinal products for human use as amended by 2004/27/EC and Directive 2001/82/EC relating to veterinary medicinal products as amended by Directive 2004/28/EC). The decentralised procedure provides equivalent grounds for testing in all member states, as the MA of a DCP product (similar to an MRP product) is based on the same dossier. During the annual meeting of the General European OMCL Network in May 2007, it was decided to include post-marketing surveillance of DCP products within the group's scope.
The Procedure
For a complete description of this scheme's procedure, download the document "Co-operation in post-marketing surveillance of Mutual Recognition/Decentralised Procedure Products (PA/PH/OMCL 06 116 7R)" via the right-hand menu.
Achievements in 2011
The 7th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out. More than 700 product testing projects were allocated to the 2011 programme, which is about the same as in 2009 and 2010. The number of participants has stabilised in recent years to around 20 OMCLs per annum.
The most tested products during 2011 were generic medicines, including the following active pharmaceutical ingredients (APIs): topiramate (antiepilepsy drug), amlodipine (calcium channel blocker), escitalopram (antidepressant), montelukast (leucotriene receptor antagonist), lansoprazole (proton-pump inhibitor), and gabapentin (GABA analogue). Approximately 3% of the tested products were biologicals, which reflects the approximate ratio of biological medicines registered via the MR and DC procedures. In 2011 about 15% of the reported tests were repetitions (repeated testing of products already included in earlier programmes); this is a common ratio for routine post-marketing testing and part of the market surveillance concept.
The internal database used for planning, sampling and reporting of MRP/DCP product testing activities within the Network was further developed. A total of 14 database amendments were implemented in 2011. These were initiated both by OMCL users of the system and the EDQM Secretariat.
To date about 3,900 projects have been registered, 32 OMCLs have so far contributed as Testing OMCL, 42 OMCL records have been established and more than 170 OMCL representatives are registered users of the database. The database plays an important role in the discussions ongoing within the Heads of Medicines Agencies Working Group on Product Testing (HMA WGPT) on how to improve collaboration between regulators/assessors, inspectors and OMCLs.
In December 2011 the coordination activities of EDQM with respect to the MRP/DCP product market surveillance scheme which are certified for ISO 9001, have undergone a re-audit.
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