The ACS PharmaProtect GmbH, as part of securPharm, is an integral part of the protection shield to prevent falsified medicines from entering the legal supply chain.
For the set up of a system for the authentication of medicines according the specifications of the Falisfied Medicines Directive 2011/62/EU and the Delegated Regulation no. 2016/161 (EU), securPharm e.V. was founded already on March 16, 2012 as non-profit stakeholder organisation.
Parallel to this ACS PharmaProtect GmbH was founded on June 22, 2012 as operating company of the database system of the pharmaceutical industry in Germany. Shareholder of the ACS PharmaProtect GmbH are the pharmaceutical associations BAH, BPI, Pro Generika and vfa. Following an extensive bidding process ACS assigned Arvato Systems GmbH as competent partner for the development, implementation and the operation of the databse system.
The core task, as the operator of the database system of the pharmaceutical industry, is to store all pack data for all prescription medicines put into market in Germany, which have to be uploaded by the pharmaceutical companies into the ACS database and are necessary for the verification in the end-to-end verification mode. It therefore plays a major role in the implementation of the Delegated Regulation. Furthermore ACS with it’s employees functions as contact for detailed questions regarding the connection to the system and project-specific requirements and the support of already connected pharmaceutical companies.
It is the goal of the ACS PharmaProtect to supply a database system till the effective date February 19, 2019, which is able to fullfill in the obligatory operation phase all necessary requirements of the pharmaceutical companies, which put medicines into the German market. The pilot operation running since January 1, 2013 already now reproduces effectively the core functions of the systems. That’s why German pharmaceutical companies may use the ACS nationally and train corporate internal processes in practice. From the resulting insights the system is continously adapted and completed. Moreover the system is connected since July 2014 with the European Hub (EU-Hub).
To be prepared for the effective date February 9, 2019 by now already over 100 pharmaceutical companies use the possibility to upload pack data directly or via the EU-Hub into the database system of the ACS.
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