Thursday, February 11, 2016

European Commission publishes the final text for the Falsified Medicines Directive Delegated Regulation

The European Commission has published the long-awaited Delegated Regulation, setting out the requirements for the future system of medicines verification that must operate in all EU countries.

of 2 October 2015 
supplementing Directive 2001/83/EC 
of the European Parliament and of the Council 
by laying down detailed rules for the safety features appearing on thpackaging of medicinal products for human use. 

This Regulation lays down: 
 (a) the characteristics and technical specifications of the unique identifier that enables the authenticity of medicinal products to be verified and individual packs to be identified;
(b) the modalities for the verification of the safety features;
(c) the provisions on the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained;
(d) the list of medicinal products and product categories subject to prescription which shall not bear the safety features;
(e) the list of medicinal products and product categories not subject to prescription which shall bear the safety features;
(f) the procedures for the notification to the Commission by national competent authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification in accordance with the criteria set out in Article 54a(2)(b) of Directive 2001/83/EC;
(g) the procedures for a rapid evaluation of and decision on the notifications referred to in point (f) of this Article. L 32/6 EN Official Journal of the European Union 9.2.2016

Tuesday, February 09, 2016

The European Medicines Verification Organisation (EMVO) signs framework agreements with service providers to establish blueprint systems

The European Medicines Verification Organisation (EMVO) is a Luxembourgish non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines
Its founding members are EFPIA, the European Federation of Pharmaceutical Industries and Associations, the EGA, the European Generic and Biosimilar medicines Association, PGEU, the Pharmaceutical Group of the European Union, GIRP, the European Association of Pharmaceutical Full-line Wholesalers and EAEPC, the European Association of Euro-Pharmaceutical Companies.
The stakeholder organisation EMVO last Friday finalised its contract negotiations with 3 partners that will be the preferred providers to implement the repositories system in compliance with the Falsified Medicines Directive. The 3 partners are: Aegate Holdings Limited, Arvato Systems GmbH and Solidsoft Reply.
The repositories system will allow the verification for authentication of medicines in Europe. For this purpose 5 European stakeholder associations (EAEPC, EFPIA, EGA, GIRP and PGEU) have established in February of this year a non-profit organisation EMVO that is taking the lead in the creation of this system.

Thursday, February 04, 2016

OpenMedicine drive towards tangible outcomes – a triple win for Europe

The openMedicine Expert Council met for its 2nd meeting on Jan. 21 to 22, 2016 at the CEN – CENELEC Management Centre in Brussels, Belgium. It was very well attended by more than 30 experts from Europe and the USA. They represented medicinal productsstandardisation, and regulatory bodies, the European Commission, and the core project team.
Based on and guided by first year project results, the experts
  • intensely discussed critical issues and challenges brought forward both by council members and the openMedicine team
  • debated options for standards and their impact on prescriptions, their dispensation at community pharmacies in another country, patient summaries and drug databases
  • contributed suggestions on providing ultimately a set of recommendations for EU member states as well as an implementation roadmap on how to assure the univocal cross border identification of medicines for human use wherever needed.