An initiative to protect the German pharmaceutical supply chain from the entry of falsified medicines into the legal supply chain.
The risk of falsified medicines is growing on a global scale. As a result, the European Union has stipulated a catalogue of measures in Directive 2011/62/EU to prevent falsified medicines from entering the legal supply chain. The EU Commission has published additional technical details for the further design of security features with the Delegated Regulation (EU) 2016/161 in the Official Journal of the European Union. With the Amendment to the German Medicinal Products Act (AMG) passed in the fall of 2012, the German legislature has transposed this directive into national law. Starting from February 9, 2019 only prescription medicines which bear the new safety features may be put into circulation in Germany.
In order to meet the legal requirements, a system for the verification of pharmaceuticals was developed.
The medicines verification system
As part of the securPharm initiative, a medicines verification system was developed based on which the authenticity of each individual pharmaceutical sales pack can be verified by authorized users, especially in pharmacies, in order to remove from circulation those pharmaceuticals that are suspected of being falsified products before they are dispensed to patients.
The medicines verification system consists of various systems, including the database system of the pharmaceutical industrie (“MAH system"), which is operated and further developed by ACS PharmaProtect GmbH.
The marketing authorization holder places an individual serial number on each pack during the production process. This serial number, along with the Pharmazentralnummer (PZN), embedded either in the Pharmacy Product Number (PPN) or National Trade Item Number (NTIN), batch number and expiry date are printed in a data matrix code on the pack. In future all elements of the Unique Identifier have to be printed in plain text.
Subsequently, this information is transmitted to the ACS-MAH-System. To verify a pack, e.g. the pharmacy staff scans the data matrix code on the pack. In the background, the serial number and product number are verified against the database. This is done by involving a second system (pharmacy system) for the purpose of anonymization of the data query. The status of the pack noted in the ACS-MAH-System is then reported back to the pharmacy. If it is correct, the pack can be sold, which also results in a status change for this pack in the database; the pack is then registered as “dispensed” in the system. If a second pack with an identical serial and product number is to be verified, the system recognize automatically that it has already been used and the pack can't be dispensed.