Progress: 60th pharmaceutical company joins securPharm
Frankfurt/Main, July 5, 2016 – Nearly five months after the publication of the EU Delegated Regulation regarding the Falsified Medicines Directive, the 60th pharmaceutical company joined securPharm, the German protective organization against falsified pharmaceuticals. This initiative now also includes some of the top 20 pharmaceutical companies such as Bayer Vital GmbH, Lilly Deutschland GmbH or Janssen-Cilag GmbH. However, the majority of companies that have joined under the mounting time pressure are medium-sized.
“A positive trend is clearly recognizable and we hope it will continue,” said Dr. Reinhard Hoferichter, spokesman of the Board of Directors of securPharm e.V., the non-profit German stakeholder organization that develops the system for the authentication of prescription drugs. “In view of the time constraints, additional pharmaceutical companies should react and join securPharm in order to be able to practice the internal corporate processes under real-life conditions before the start date of February 9, 2019. This is a unique opportunity for identifying and excluding possible internal error sources.”
All pharmaceutical companies with prescription drugs in their portfolio must connect to the database of the pharmaceutical industry to upload the data required for protection from falsification. The database system for the pharmaceutical industry is operated by ACS PharmaProtect GmbH. More than 25 million package data have already been uploaded to the securPharm system.
An early connection to the database system also makes sense if the companies have not yet created the necessary technical prerequisites for serialization. The exchange of experience organized by ACS PharmaProtect for the companies that are already connected to the system represents an opportunity for accelerating a company’s own associated processes and for an exchange with other pharmaceutical companies.
The objective of the Falsified Medicines Directive and Delegated Regulation (EU) 2016/161 is to protect patients from falsified pharmaceuticals in the legal supply chain. For this purpose, the existing regulations and controls are supplemented with mandatory technical solutions. Starting on February 9, 2019, production and marketing will be restricted to those prescription drugs that bear an individual serial number and protective features that clearly show whether a package was previously opened or is completely intact.
For further information regarding this press release please contact:
Mrs. Nathalie Steinhauser (spokeswoman securPharm e.V.)
phone: +49 (0)69 97 99 19-43