Serialization


Serialization of pharmaceutical products

We do our best to offer the highest quality of products to our contractors, according to the requirements of the Directive of European Parliament and Council 2011/62/EU of 8 June 2011 and the Order of the Committee Delegate (EU) 2016/161 of 2 October 2015.

Prescription medicinal products (Rx), with the exception of so-called ,,white list” (radiopharmaceuticals, homeopathic medicinal products and medical gases) and over-the-counter (OTC) medicinal products from the so-called ,,black list” (of which incidents of counterfeiting were found in the European Union or third countries) are subject to serialization from February 9, 2019.

Each unit package is provided with security features dedicated to:

• the medicinal product authenticity verification;

• identification of the unit package.

These are: 2D Data Matrix code carrying a unique identifier (UI) including the required human readable information:

• GTIN (product code) • SN (serial number)

• NN (national reimbursement number), if applicable

• EXP (expiry date)

• LOT (batch no.)

Element preventing tampering with the packaging (ATD – Anti-Tampering Device)

Related to serialization we offer to our clients:

  • a modern line for applying the 2D Data Matrix code that carries a unique identifier (UI) along with the required information and for placing security features in the form of labels, preventing tampering with the packaging;
  • software that generates a serial number in such a way that its sequence does not repeat for a minimum of 5 years and encoding the required information in the 2D Data Matrix code;
  • fast and efficient fiber optic link for contact with EMVO.
  • devices for verifying the quality and readability of 2D Data Matrix code in accordance with ISO 15415;
  • scanning devices for scanning 2D Data Matrix codes;
We offer our clients the possibility of reporting
to EMVO on their behalf.

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Do you want to know more details about our offer? Get started today! Call us or write to us and we will select the best solution for you.