The SecurPharm project started on 31 August 2011. This initiative has been developed by the following organisations: BAH, BPI, VFA, Pro Generika, PHAGRO, and ABDA. 270 specialists and managers from the pharmaceutical industry met at the Jahrhunderthalle in Frankfort.
The objective of the project is to implement the new safety features for medicinal products required in the new EU Directive 2001/83 (Pharma Directive). The EU Directive doesn't provide any details about the practical implementation. A clear identification on each medicinal product should prevent falsified products to enter the legal supply chain. This system is obligatory for all medicinal products subject to prescription. Many OTC products with "counterfeiting risk" will also be concerned. The EU Commission will publish a list of the products in question.
Because of the involvement in the SecurPharm initiative of all German Association of Pharmaceutical Manufactures as well as of the The German Society of Hospital Pharmacists and the German Wholesaler Association, one may expect that SecurPharm will become the relevant standard for all pharma companies in Germany and possibly in other European countries too.
The motto of the initiative is "end to end" instead of "track & trace". In a "track & trace" context, data are read out in each supply phase of the medicinal product while in an "end to end" solution, verification and data comparison should be performed in the pharmacy.
Many points of SecurPharm are based on the experiences taken from so-called EFPIA Pilot Projects on 2D Matrix Code in which the feasibility of a 2D Matrix system was tested in 2009/ 2010. However, essential differences to the EFPIA Pilots can be noticed: for example, no central database is used for the data management. Instead, the SecurPharm project will use 2 separated data management systems and meet thus a critical point of the Pharmacists Association ABDA. This critical point has led the EFPIA project - which was originally planned to be carried out in Germany - to be performed in Sweden.
In the SecurPharm Project, pharmacists have access to another database than the pharma industry. But the SecurPharm system will also require the presence of 2D Matrix Codes (like in the EFPIA Pilots) and an end-to-end verification system. This means that the pharma company creates the 2D Matrix Code and the pharmacist reads it and compares it with the information available in the database. Wholesalers will have access to the database information too in suspected cases. This access should not be the rule but an exception.
The SecurPharm Pilot should begin in 2013. The pilot phase will already be the first phase of the market launch. This means for pharma companies in Germany who want to be involved in the project that the necessary investments for packaging devices should be operated now. This is the only way to ensure the identification of the products to be supplied in the pharmacies by the project start on 1. January 2013
Already from October 2011, the specification code will be provided in detail for companies. This code will give detail requirements for companies regarding the application for the individual 2D Matrix Code.
With the new approach, the 2D Matrix code won't be created by an existing issuing agency (like GS1) but by the IFA. Currently, the IFA is responsible in Germany for the allocation of the "PZN" (central pharma number). Until now, the PZN has been marked on the medicinal product as a barcode but will be integrated into the 2D Matrix Code in the future. The IFA has thus applied for registration as so-called issuing agency. In this way, the IFA will be one of the around 30 worldwide issuing agencies.
The generation of a data string for the 2D Matrix Code will be based on following components:
Even if the PZN is only required in Germany, it will be possible for other European countries to use the IFA system.
The European Compliance Academy organises a conference on the implementation of the Pharma Directive on 5-6 October in Berlin. Beside other current topics like the new GDP Guideline (presentation from the EMA), the new requirements on GMP compliant APIs and excipients (presentations from the APIC and IPEC), 2 presentations will also be held about the implementation of the 2D Matrix Code identification system.More information here.
Author: Oliver Schmidt, Concept Heidelberg (a service provider entrusted by the ECA Foundation)