The Council of Europe will open and inaugurate on 15 November the new secondary site of the European Directorate for the Quality of Medicines & HealthCare (EDQM) in Ars-Laquenexy, close to Metz in eastern France. It will enable the safe storage of contingency stocks of European Pharmacopoeia reference standards and ensure their distribution worldwide in the event of major incidents at its main site in Strasbourg.
European Pharmacopoeia (Ph. Eur.) reference standards are an indispensable component of the application of Ph. Eur. quality standards; they are used in pharmaceutical analysis, for example, for identification, purity tests or assays according to the corresponding monographs or general chapters of the Ph. Eur. These reference standards are essential for the quality control of medicines. Interruptions in their supply to health authorities, official medicines control laboratories and pharmaceutical manufacturers would mean blocking the release of medicines to the market in Europe and non-European countries which apply the Ph. Eur., thus depriving patients of their medicines.
The new site is part of the EDQM’s business continuity strategy based on the creation of a full backup stock in order to mitigate risks of disruptions to supplies of Ph. Eur. reference standards. Snežana Samardžić-Marković, Director General of Democracy of the Council of Europe, explains the reasons behind the investment for the building: “The reference standards produced by the EDQM are fundamental to guarantee that all patients in Europe and beyond have uninterrupted access to the good-quality medicines they need”.