The European Federation of Pharmaceutical Industries and Associations (EFPIA) is pleased to announce the official launch of the tendering process for key components of its European Medicines Verification System (EMVS) as of 5th April 2012.
EFPIA plans to prove the efficiency and to demonstrate the viability of the EMVS through real-life implementation ahead of the publication of the European Commission’s Delegated Act on Safety Features (expected by 2014). The stakeholder-governed solution proposed by EFPIA and its partners in the pharmaceutical supply chain is indeed likely to constitute the key solution for future implementation of the Falsified Medicines Directive.
The EMVS will consist of the following key components:
(1) One European Hub including the interfaces to manufacturer and parallel distributor systems and to the national systems;
(2) The template of a National Blueprint System (nBPS) including the interface to (a) the European Hub and (b) the pharmacy and wholesaler systems.
The tender process will comprise the following steps:
1. Information for potential vendors and release of RFI to selected potential vendors on 5th April 2012;
2. Information Workshop with public “Question & Answers” session – Renaissance Hotel, Ballroom 2, Rue du Parnasse 12, 1050 Brussels on 19th April 2012 (9.00h-13.00h);
3. Evaluation of submitted responses to RFI by EFPIA and decision on vendor shortlist on 13th June 2012;
4. Release of request for proposal (RFP) to shortlisted vendors on 15th June 2012 (deadline: 27th July 2012);
5. Evaluation of submitted responses to RFP and final decision by EFPIA on 4th September 2012.
Interested vendors (i.e. EDQM as a potential service provider) are invited to submit their RFI proposals by 25th May 2012 (COB).
Click here for further information on the tender process.
Andreas M. WALTER, Coding & Serialisation Project Director Tel: (+32) 2 626 25 55
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 35 leading pharmaceutical companies, EFPIA provides the voice of 2,000 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world.
EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
The pharmaceutical sector directly employs some 640,000 people in Europe including 115,000 working in research and development in 2010. The industry also generates around three to four times more employment both upstream and downstream.
Europe’s research-based pharmaceutical industry generates a substantial trade surplus, estimated at about €46,800 million in 2010, and has contributed significantly to reducing the European Union’s trade deficit in high-tech products. € 27,000 million were spent on research and development in Europe in 2010. Almost a quarter of the EU’s high-tech exports are pharmaceutical products.