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New safeguards for patient safety as Falsified Medicines Directive comes into force


Health & Consumers
  • The implementation of the Falsified Medicines Directive (FMD) safety feature requirements is a major milestone for patient safety in Europe.
  • The FMD system, operational as of 9th February 2019, aims to prevent falsified medicines from entering the legal supply chain which brings medicines to patients.
  • The pharmaceutical industry invested over 1 billion euros for the new system.
  • For lower cost, but very essential medicines, it is imperative to engage in dialogue with national governments on how to sustain supplies in the future.
The EU Falsified Medicines Directive was adopted in 2011 to prevent falsified medicines from reaching patients in Europe. Following lengthy discussions on the technical requirements to serialise between 10 and 14 billion packs of medicine every year, the system will start functioning across Europe as of the 9th February.
Prescription medicines in hospitals and pharmacies (the ‘legal supply chain’) must bear a 2-D datamatrix and anti-tampering device to enable pharmacists to verify their authenticity.
For the generic industry, which supplies over 67% of prescription medicines, this project was a massive undertaking from a manufacturing, IT and regulatory perspective. Medicines for Europe commends our manufacturers and the associations which have set up the European and national IT hubs (EMVO & NMVOs) for their incredible commitment to deliver this project on schedule. Medicines for Europe looks forward to strong cooperation with stakeholders and partners (other industry associations, wholesalers and pharmacists) to iron out the last of the technical challenges associated with this IT megaproject during the stabilisation period.
The industry funded system has required an investment of over 1 billion euros from manufacturers to update production and packaging lines and will require a further 100-200 million euros annually to maintain the IT infrastructure. These costs simply cannot be absorbed for the majority of generic medicines on the EU market. Consequently, Medicines for Europe will call on national authorities to review the sustainability of supplying Europe’s essential medicines at very low cost while having to invest in massive regulatory compliance projects like FMD.
Adrian van den Hoven, Director General of Medicines for Europe says: “Medicines for Europe congratulates our member companies, fellow industry and supply chain partners and EMVO/NMVOs for their incredible effort to make FMD operational on time. This is a massive undertaking and we are committed to stabilising this important system for patient safety with our partners over the next few months. The financial investment by our members has been astronomical and this poses a particular challenge to the sustainability of the generic medicines sector. Industry and authorities need to have a focused dialogue to ensure patient access to essential medicines is not jeopardised in the future. This kind of dialogue should urgently take place for our members to be able to support long-term sustainability of European healthcare systems and continue to deliver on better health for patients.”
About Medicines for Europe
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at and on Twitter @medicinesforEU.