Background

In October 2008, a Reflection Group on Quality Monitoring of Stockpiled Medicines was established with the secretarial support of the EDQM. This Reflection Group is composed of representatives of OMCLs from countries that are members or observers to the European Pharmacopoeia Convention, as well as one representative from DG-SANTE.

The aim of the Reflection Group, in the first instance, was to elaborate strategies on how to make other stakeholders aware of the competency of OMCLs in contributing to the quality monitoring of nationally stockpiled medicines.

This initiative of the OMCL Network is supported by a statement from the Council of the EU, dated 08 December 2008. Under item 13 of the Conclusions on Health Security, 16515/08 SAN 303, the Council invites Member States and the Commission "to initiate a process of reflection, in the appropriate fora, concerning cooperation on necessary measures on strategic medical products to ensure that national stockpiles are operational and managed in a cost efficient manner, in particular with regard to the availability of supply and shelf-life extension programmes based on appropriate national control mechanisms."

Between 2009 and 2010, the Group produced a position paper on "Stockpiling of Medicines : Monitoring - General considerations," and a technical guideline on "Monitoring of Stockpiled Medicines - Development of Technical Guidelines".

The OMCLs involved in these activities share technical information via an IT platform with controlled access, which is provided by the EDQM to foster communication and information exchange.