Germany links to EU drug traceability platform

Germany's medicine traceability system - securPharm - is working under market conditions and is ready to meet the requirements of the Falsified Medicines Directive.

That was the message delivered by representatives of the initiative at a conference in Frankfurt to discuss progress with Germany's efforts to comply with the FMD (Directive 2011/62/EU) and make sure patients are protected from counterfeit, expired and recalled drugs.

It was also announced that securPharm has now been linked to the European Medicines Verification System (EMVS) hub, a platform that will handle the transactional data generated as serialised codes are added to products and move through the supply chain.

That means pharmaceutical manufacturers will now be able to upload their serialised product data onto the system. At this stage 16 companies have committed to take part in the rollout of the system and to establish a connection with the hub.

"On July 1, the link was established between the European hub and the German repository system," said the European Medicines Verification Organisation (EMVO) in a statement issued today.

That link "marks the start of the EMVS … and means that the EMVO/hub is now able to fulfil its four-pillared mission to safeguard the European supply chain against of the risk of falsified medicines," said the organisation's director general Andreas Walter.

The announcement was made shortly after 400 representatives of pharmaceutical companies, wholesalers, pharmacists and their national and international associations participated in the 2nd securPharm European Conference on the FMD.

About 700 million packages of prescription drugs per year will have to be printed with datamatrix code that includes an individual serial number, thereby rendering each package unique. The packs are verified at the point they are dispensed and - if the code has been used before or is invalid - the pharmacist can prevent the drug reaching the patient's hands.
 
The meeting heard that in Germany alone the new requirements for serialising and verifying medicine packs affect about 500 pharmaceutical companies, 20,000 pharmacies as well as hospital pharmacies, and all pharmaceutical wholesalers.

At the moment, stakeholders in the pharmaceutical supply chain are waiting for the delegated act on safety features - due this year - which will specify the technical and organisational requirements for the implementation of the FMD.

Following publication, there will be a three-year implementation period until the provisions of the Directive become legally effective in all of Europe.