These activities involve the EU/EEA OMCL Network only.
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 700 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.
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 12R)" via the right-hand menu.
Benefits of the MRP/DCP Post-Marketing Surveillance Scheme
A position paper: History, results and benefits of testing MRP/DCP products (PA/PH/OMCL (12) 57 3R, was released in July 2013. 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.
Achievements in 2016
In 2016 the 12th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out. About 1100 product testing projects were allocated to this programme, which is an increase in comparison to the figures of previous years of around 10 percent. The test reports came from 25 different OMCLs.
The most tested products during 2016 were generic medicines, including the following active pharmaceutical ingredients (APIs): olanzapine (antipsychotic); amlodipine, carvedilol and bisoprolol (treatment of high blood pressure), escitalopram (antidepressant), donepezil (treatment of Alzheimer’s disease), methylphenidate (psychostimulant).
Around 6 percent of samples tested in the programme originated from a Member State or an OMCL that was not involved in the testing. This demonstrates the added value of the surveillance scheme with respect to work-sharing and the efforts of the OMCLs to include samples from other Member States in their national testing programmes.
In about 1 percent of the tested materials, findings regarding regulatory issues could be identified, (e.g. mistakes in leaflets, insufficient details of test method, primary packaging issues), and in 3 percent of the cases one or more out-of-specification result(s) were reported. Some 8 percent of the tested products were intended for veterinary use. Since 2012 more DCP-products than MRP-products have been included in the annual programmes. This trend continued in 2016.
The corresponding database meanwhile holds about 8400 testing records of MRP- and DCP-products with contributions from 34 OMCLs. When the total numbers of tested products marketed in participating Member States are compared to the numbers of products reported to be tested between 2002 and 2016 in each participating Member State, it has been calculated that there is an average 9-fold gain for the EU/EEA countries. This means that an average participating Member State, by testing one product, benefits from the scheme by receiving the testing results for 9 marketed products generated by other Member States.
For 2017 and beyond the task remains to achieve over time, if possible, a balance between the number of samples sent by an OMCL for testing to another Network member and samples from other participants of the programme accepted by the same OMCL for testing. Discussions started in the Network how to combine the strong points of the CAP generics and MRP/DCP testing programmes.
End of 2016, compliance with ISO 9001 for the EDQM co-ordination activities with respect to the MRP/DCP product market surveillance scheme was re-certified by AFNOR.
Status as of December 2016