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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 2009
The 5th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out. 2009 saw the highest number of OMCLs ever participating and the highest number of projects registered in the MRP/DCP product testing database in one testing year. In total, 23 OMCLs from 16 Member States placed more than 700 projects on the shared IT-platform, thus showing the increased acceptance of the programme throughout the EU/EEA Member States.
The most tested products during 2009 were generic medicines including the following active pharmaceutical ingredients (APIs): risperidone, olanzapine, quetiapine (antipsychotic drugs); glimepiride (antidiabetic drug); and ramipril (ACE-inhibitor).
Since August 2009 the database is also open to users of the Communication and Tracking System (CTS), staff members of drug regulatory departments and pharmacovigilance units at National Competent Authorities (NCAs) and GMP inspectors. For these user groups access is optional and on a "read-only" basis. Based on the initiative of the OMCL users and the EDQM Secretariat, 24 improvements to the database have been implemented.
Meanwhile, about 3000 projects have been registered, 41 OMCL records established and more than 140 OMCL representatives have access. 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, inspectors and OMCLs.
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