FMD solutions

Serialization of pharmaceutical products became mandatory after Falsified Medicines Directive (FMD) went into force from February, 2019. This presented many challenges for companies working in the sector of pharmaceutical products. We offer a comprehensive solution for serialization of pharmaceutical products that is cost-effective and fully compliant to all EMVO requirements.

Electronic product enumeration system (ePES) is a cloud-based software developed by Lakameda to deliver a simple solution especially for parallel importers with their higher requirements – but the system can also work fine for original manufacturers. The front-end allows you a standardised process between stakeholders with secured file transfer/data storage and proof of actions. 

  • ePES light – a standalone software solution for independent usage by client
  • ePES full – a full-service package including decommission and commission on behalf of the client

Functionality of ePES:

  • ePES system provides you a rapid, structured and secured process of 2D codes:
  • Generate serial numbers in time for your production on batch level
  • Check of uniqueness
  • Cross-check of uploaded data file of used SN from producer
  • For parallel traders that repack or relabel original products, ePES additionally allows to:
  • Create xml files for verification of original product at EMVS
  • Control your repack buffer
  • Create XML files for your decommission at EMVS
  • Regardless if you repack or produce originals, ePES always provides you:
  • Preparation of the commission file to EMVS
  • Secure data exchange with CMO or internally between departments
  • Data storage for 5 years
  • Proof of FMD compliance to your batch releaser
  • Our offered FMD solutions in combination with ePES may also include:
  • Unique identifiers (2D codes) printed on special labels with tamper evident feature

Contact us for a demonstration and tell us your needs!