Use of the Data Matrix Code - Which Regulations apply to Coding?

The future safety features required for the implementation of the Anti-Counterfeiting Directive have to be implemented as of 9th February 2019. Moreover, the national verification systems will have to be available. The European Commission has released Version 5 of the Q&A document on safety features and also the German initiative securPharm has published a current status report for 2017. More information about the "SecurPharm Status Report 2017" and EU's Q&A document on safety features can be found in Delegated Regulation on the Anti-Counterfeiting Directive - New EU Requirements and State of Implementation.

What should be considered for the coding of medicinal products subject to mandatory verification?

In May 2016, securPharm published regulations on the coding of medicinal products subject to mandatory verification on the German market. Those regulations have been established according to the EU Anti-Counterfeiting Directive and the Delegated Regulation (EU) 2016/161.

They address coding by means of a Data Matrix Code with the product codes PPN or NTIN and further data elements. They also deal with the automated identification of medicinal product packages in the pharmaceutical supply chain.

The following sections are addressed:

  • Scope
  • Technical information concerning verification - overview
  • Coding agreements (including clinic packs)
  • Data content and requirements
  • Marking with code and human readable text
  • Quality control of the Data Matrix Codes
  • Interoperability based on XML standards

At first, the coding of the PZN in the code 39 will remain as well as other coding rules such as the EAN-13 on the industrial packages to ensure the processes established so far. The Data Matrix Code will have to be born on medicinal products subject to mandatory verification.

Regarding clinic packs, it is stated that the individual recognition feature will have to be put on the clinic pack and not the clinic component.

At the end of the document, you can find the Annexes A-G. Annex D - for example - describes the control of the Data Matrix Code.


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