EU FMD: Driving Compliance

Ensuring fast compliance for pharmaceutical companies needing to meet the European Falsified Medicines Directive

 

World Leader in Serialisation

Does your company want to continue selling medicines in the European Union?  By 9, February 2019, the EU FMD requires that every prescription drug have its own unique identifier in machine and human readable forms.  The machine-readable form must be a 2D barcode that contains the following:

  • Product Code: varies between member states between GS1, GTIN, NTIN, or a combination
  • Random serial number
  • Batch number
  • Expiration date
  • National reimbursement number (where required)

This information can be applied in the factory or at the packaging site.

Drug companies will need to send information about the products released for sale or distribution to the European Hub—including all their unique identifiers and the regions within the E.U. where those drugs may be marketed.   Systech’s serialisation stack solutions include the features necessary to meet all the requirements of the EU FMD, thus taking one big headache off your list.  This includes serial number randomization, barcode encoding, printing and verification and the communications software that will enable companies to send the required serialisation data and routing information to the European Hub at the appropriate time.

This process will enable pharmacists or the entity that dispenses or administers the drug to scan the product and verify it against this database before it is provided to a patient.

All EU member States are required to enforce the EU FMD.  The primary reason for this legislation is to protect patients from counterfeit drugs and Systech’s solutions help ensure it does.

Systech is a proven global leader in serialisation.  We have 95% of the top pharma companies calling us their solution provider.  We were the 1stregulatory based serialization solution in the world.

Our 30+ years of experience in the industry has taught us valuable lessons that we have learned from.  These lessons have taught us how to simplify the process.  Thus, enabling us as an organization to get companies compliant faster.

We partner with you from the beginning to determine the best serialisation strategy to fit your specific needs—hardware, existing lines, configurations, etc…  Our one of a kind platform allows for plug and play components to meet your individual line needs.  We even thought to future proof our software based solution to protect your investment against future regulations and/or business needs that you may encounter.  Keeping this in mind, our software easily adjusts to:

  • Updated regulations
  • New labels
  • Integrated L1-L4
  • New regions
  • Updated packaging requirements and more.

Systech is currently onboarding customers now, to get compliance faster. For more information on pricing or any other questions, contact sales@systechone.com. Learn more about the EU FMD on our EU FMD Resource Page.

Available on the EU FMD Resource Page

  • EU FMD Resource Guide
  • Regulations

Webinar

  • Meeting the Falsified Medicines Directive

Blogs

  • What is Serializ(s)ation?
  • Meeting the Falsified Medicines Directive (FMD)