Serialization I European Union Falsified Medicines Directive

Capture d’écran 2019-05-07 à 12.19.02On February 9 2019, the 2011/62/EU Falsified Medicines Directive introduced the obligation to attach safety devices on medicines to prove their integrity and authenticity. The Directive proposes measures to make the European Union (EU) medicine supply chain safer. For its part, the Delegated Regulation (EU) 2016/161 outlines the provisions within the Directive.

The new rules are mainly based on affixing an anti-tampering and authentication device on prescription medicine packaging. Until now, health product traceability was applied at batch level. From now on, each packaging line generates, prints and checks a unique data matrix code for each box, and uploads the code in a data base. The data matrix code contains several types of information: batch number, expiry date, and presentation identification code (known as the CIP code) which provide information about the medicine type.

In order to monitor and coordinate how the law is set up, the Delegated Regulation provides for the implementation of a European governing body, EMVO (European Medicine Verification Organisation), and national representative bodies, NMVOs (National Medicine Verification Organisation). These bodies are in charge of, respectively, the European-level data management system, known as EMVS (European Medicine Verification System), and that of each Member State, NMVS (National Medicine Verification System).



More than 400,000 European pharmacies affected by the Directive

In practice, security device verification means that pharmacies and health centers must be equipped with a system which checks the unique ID code on each medicine box by carrying out the following actions:
• “Data matrix” code reader affixed to the box by the manufacturer;
• Connection to a national database which checks the authenticity of the unique identifier code; this database also receives data from the EU database in which pharmaceutical manufacturers record the data of the specialties submitted for serialization;
• Serial number deactivation after national database information is received which attests the authenticity of the unique identifier.

Several setting-up issues and delays

  • In France:
    The scope of application for the unique identifier applies to all prescription medicines, except those listed in Annex 1 of the Delegated Regulation for implementing the Directive. However, whilst pharmaceutical companies are able to affix the unique codes on the packaging of their products, pharmacies are currently unable to deactivate the very same codes due to inadequate software.
  • In United Kingdom:
    To date, as no decision has been taken regarding the UK’s exit from the EU, it is hard to determine to what extent pharmaceutical regulations will be affected. If the UK leaves the EU with a deal, there will be little impact as British firms are meant to facilitate the new legislation in the same manner as Member States. If there is no deal, the British supply chain will not be obliged to apply the terms of the Falsified Medicines Directive and UK organizations will not have access to the EU central database.
  • In Belgium:
    The new system for labeling prescription medicines appears to be problematic for pharmacists and patients. Some medicine packaging and doses are said to be currently unavailable, often for several months at a time. The new labeling legislation, as provided for in the EU Fake Medicines Directive, is the reason behind the issue.
  • The Netherlands:
    The Falsified Medicines Directive could wipe some medicines off the market.
    The new EU directive requirements come with a significant price tag, but the EU has not made extra money available. As well as fronting the money to develop EU and national databases, companies have to redesign packaging and buy new hardware and software that can add expenses of around €500,000 per packaging line, according to Medicines for Europe. In the Netherlands, where prices are low in part because health insurers are allowed to pick the cheapest version of a medicine, these additional costs are affecting business decisions. “There’s not enough margin in our prices to overcome these costs,” said a spokesperson from the Dutch association for generic medicine manufacturers. “If there is no solution for these extra costs, there will be the risk that the companies will withdraw their products.” Older generics, that have been on the market for decades and are sold for pennies, such as many antibiotics, could be hit particularly hard – as could medicines made by smaller companies producing less than 100,000 units.

Serialization: global overview

Adents-serialization-mapSerialization is already mandatory in many countries such as Argentina, Saudi Arabia, Iran, South Korea and China. Turkey was one of the first countries to adopt serialization and numerous others have based their laws on Turkey’s experience.

• Belgium, Greece and Italy have already set up coding systems and have until 02/2025 to harmonize their systems with the Falsified Medicines Directive requirements. Some non-Member States like Switzerland, Norway and Iceland have decided to apply the Falsified Medicines Directive.
• Serialization has been mandatory in the US since November 2017, however, the Food Drug Administration (FDA) has stated that it “will not take actions against manufacturers who have not affixed or printed a unique ID code on each medicine packaging before November 27, 2018”.
• Pakistan will implement pharmaceutical serialization in December 2019, followed by Jordan (01/2020). Russia is still changing deadline information. At the time of printing, the official deadline was January 2020.
• In Brazil, serialization and aggregation will be mandatory as of 12/2021.
• On the basis of Saudi Arabia’s initial experiences with serialization, other members of the Cooperation Council for the Arab States of the Gulf are likely to do the same, and will adapt needs if necessary.
• Ukraine will probably implement supply chain safety measures given that its neighboring countries, Europe and Russia, have implemented serialization.
• India is currently demanding serialization and aggregation for exports only and will most likely extend current legislation to pharmaceuticals intended for the domestic market.

WHO has announced that it will develop guidance to help Member States implement medicinal product traceability systems. Its priority task will be to summon a group of experts to assist with publishing “a normative guidance on the establishment of traceability systems and on the policies needed at national and regional level.”

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