securPharm sounds promising. Is it really?

Due to the fact that counterfeiting of medicinal products has been increasing, the European Commission has published the directive 2011/62/EC amending directive 2001/83/EC in order to address this situation. The directive requires safety features for certain medicinal products to provide verification of the authenticity and identification of individual packs, and evidence of possible tampering. In Germany, stakeholders formed the project “securPharm” for developing a system, which is able to be in compliance with the requirements of the EU directive.

The verification of authenticity and identification of individual packs will be realized by printing a 2-D-Code (Data Matrix) on each pack. The code contains a product number (Pharmacy Product Number, PPN), which incorporates the German reimbursement number PZN, a safety feature required in the human medicine law in the form of a randomized serial number applied to an individual package, which can be verified against the original data of the medicine manufacturer. The code also includes the expiry date and production batch number.

The PPN structure is designed to allow for the embedding of any other national medicinal product numbers. This allows for an easy upgrading of proprietary national systems into internationally unique product number systems. The securPharm specification on PPN code is based on international ISO standards. In this way, the machine readability of the data elements is assured. The technical prerequisites for the implementation of the EU directive for protection against counterfeit medicines and also the anticipated additional requirements for verification of medicinal product packages are met.

Time line:

  • 2012: Development of technical specifications for coding and verification /scheduling and preparation pilot-project
  • 2013: execution of the pilot project: period 2-3 month
  • 2013-2017: planning and preparation of comprehensive “roll-out”
  • 2017: 3 years after publishing the delegated legal act: implementation of safety features on the market

The members of the securPharm project have a certain amount of risk: The development is done before the European Commission has published the delegated legal act. The advantage is that they have the probability to make arrangements for the innovations and to collect experiences. Nevertheless it is an investment in an unknown future.

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