MRP/DCP Post Marketing Surveillance Scheme

These activities involve only the EU countries of the OMCL Network

Post-marketing surveillance of products with a Marketing Authorisation according to the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP)

(20/06/07) The end of 2000 saw the creation of a new coordinated testing scheme of the EEA OMCL Network focusing on the post-marketing surveillance of MRP products. This category of medicinal products includes the important group of generics. The programme was initiated by a selected number of OMCLs from EEA countries and EDQM. After a trial phase that lasted for almost 4 years, it was finally decided in May 2005 to continue with a regular annual programme. This voluntary post-market surveillance scheme has since been regularly followed by about 15 OMCLs from 10-12 member states. Several additional OMCLs, mainly from the "new EU member states", have announced their interest in contributing to the programme in future. The testing exercise is based on the principles of work-sharing and sharing of results, which is possible due to the nature of the mutual recognition procedure, which enables marketing authorisation (MA) of a medicinal product in more than one EEA country in a harmonised way. For post-marketing testing this provides a coordinated and cost-saving approach by avoiding duplicate testing of the same product in different member states. For the time being the yearly programme covers about 300 medicinal products marketed in the EEA, which are checked for quality. In order to guarantee communication between the participating national OMCLs EDQM has installed an IT share point, which is accessible to OMCL network members actively involved in the programme.

A new challenge for the testing group is the implementation of a new community marketing authorisation procedure (decentralised procedure-DCP), which is in force since end of October 2005 following the end of the transmission period for the ratification of directives 2001/82/EC ("veterinary code") and 2001/83/EC ("human code") as amended. This new registration procedure provides equivalent grounds for testing, as MA of a defined "decentralised" product - similar to an MRP-product - is based on the same dossier throughout the member states. During the annual meeting of the OMCL network in May 2007 it has been officially decided to include this new type of products in the scope of activities of the group.

A complete description of the MRP/DCP-testing scheme is available in the document "Co-operation in post-marketing surveillance of Mutual Recognition/Decentralised Procedure Products (PA/PH/OMCL 06 116 2R)" (see download section), firstly adopted by the EEA OMCL network in May 2006 and recently revised in May 2007.

Achievements in 2007

In 2007, the third regular programme of post-marketing surveillance of MRP-products was performed after running a trial phase between 2000 and 2005. During this year, for the first time, the OMCLs were also encouraged to consider DCP (Decentralised Procedure)-products in their individual testing plans. By the end of 2007, about 10% of medicines out of the pool of former MRPs were authorised via this new community procedure.

15 OMCLs have actively participated in this year’s programme and approximately 330 projects (compared to 250 in 2006) could be finalised.

The most important step taken during the last year was the launch of Version 1.0 of the MRP/DCP-product testing database in July. Access to this computer application is restricted to OMCLs involved in the programme. This IT tool allows a better coordination of the planning, sampling and reporting phase, but also provides a platform for information exchange about follow-up actions taken on the basis of test results. This piece of information had not previously been considered in the programme. In a next step it is planned to grant reading access to the users of CTS (Communication and Tracking System), the regulators of national competent authorities. The MRP/DCP database is one of the contributions to a closer collaboration of the OMCL Network and EDQM with the owners of the CTS, the Heads of Medicines Agencies, who have expressed their interest in the MRP/DCP testing scheme.

For the establishment of future annual programmes it was decided to introduce principles of risk assessment in the selection process of test products. During 2007 a trial phase group consisting of 7 volunteering OMCL participants from 6 member states has enhanced a risk-based model after ranking in a “test run” 50 randomly selected MRP-products from the national markets and 15 pre-selected common MRP-products, employing the original model. It is intended to use the refined model as selection tool also for the planning of other conjoint network activities (CAP programme) and of national testing campaigns.

Product Specific Guidelines and EC Procedures

Additional Information and Downloads

MRP/DCP Post-Marketing Surveillance

Co-operation in post-marketing surveillance of Mutual Recognition/Decentralised Procedure Products (PA/PH/OMCL 06 116 2R, May 2007)

OMCL Activities

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