EU Falsified Medicines Directive (FMD 2011/62/EU)

  • By Bart Vansteenkiste
  • March 17, 2011
  • Life Sciences
  • Pharmaceuticals

Adopted in 2011 the EU Falsified Medicines Directive (FMD 2011/62/EU) aims to decrease incidents of falsified medicines reaching the open market within the European Economic area resulting in improved patient safety.

The delegated acts which were published in the official Journal of the EU on the 9th of February 2016 will affect manufacturers, generics producers, contract packers, re-packers, importers and any producer intending to supply pharmaceutical product or active pharmaceutical ingredients into any of the EU 27 countries.

Broadly the requirements of the Directive‘s delegated acts fall into five categories:

  • Obligatory feature on the outer packaging of medicines to demonstrate identification and enable product verification
  • Obligatory feature on the outer packaging of medicines to demonstrate that they have not been tampered with
  • Strengthened requirements for the inspection of the manufacturers of active pharmaceutical ingredients
  • The obligation for manufacturers and distributors to report any suspicion of falsified medicines
  • An obligatory logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.

From 9th of February 2019 onwards manufacturers failing to comply with any aspect of the directive will have to withdraw their products from the European market.

Domino has extensive experience in developing and manufacturing legislative compliant coding solutions for the pharmaceutical sector. Recognising the challenge to manufacturers in complying with emerging global legislation Domino employs dedicated legal, validation and global standards specialists. Technology meets the demanding requirements of high speed serialisation lines whilst ensuring code quality, high OEE and maximum uptime.

    Domino recognises counterfeit and falsified products as a serious global issue for the Life Sciences industry. Our legislative compliant solutions enable pharmaceutical and healthcare manufacturers to protect the integrity of the product and the safety of end users. Bart Vansteenkiste, Global Sector Manger – Life Sciences

    Suggested products?

     

    The following coding and marking technologies facilitate the identification and verification of product at item level as required by the EU FMD.

     

    Thermal inkjet

    • Specially developed sector inks ensure excellent dry time, contrast and colour-fastness from manufacture to point of dispensation
    • i-Tech components combine to create a flexible, reliable system, including reduced ink wastage through unnecessary cartridge changeover
    • Capable of high speed serialisation at item level

     

    Laser

    • The fastest laser available which will meet virtually all sector coding requirements on labels and cartons
    • Easy integration into existing lines or Original Equipment Manufacturer’s (OEM’s) equipment
    • Capable of very high speed serialisation at item level

     

    Thermal transfer overprinting

    • Market leading performance for high speed serialised label and flexible  package printing
    • Comprehensive software suite for simple integration with existing technology
    • i -Tech Ribbon Drive reduces ribbon use by up to 60%
    • More information here on Domino’s range of thermal transfer overprinting technology

     

    Print & Apply

    • Unique pad design caters for standard label sizes and ensures that the label is fully controlled during printing and application
    • Vaccuum on functionality to ensure no label (unique number) gets lost when the line is stopped 

    More questions, have a look at our FMD Questions and Answers

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