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New pharma companies join securPharm system

securPharm logoA number of new drugmakers have joined Germany's securPharm system, designed to meet the requirements of the EU's Falsified Medicines Directive (FMD).

In the fourth quarter of 2015, nine new companies have connected to securPharm, Germany's national authentication platform, which was linked to the European Medicines Verification System (EMVS) hub last year.

The companies can now start to comply with the delegated act on safety features, which specifies the technical and organisational requirements to help protect patients from falsified, expired and recalled medicines.

The crop of new companies - which includes a number of smaller manufacturers - are Biokanol Pharma, Bristol-Myers Squibb, Celgene, Chemische Fabrik Kreussler, Dr Kade Pharmaceutical, Ferring, Jena Pharma, Mibe and OmniVision.

"The increased interest is an indication that more and more companies want to align their internal processes so that they meet the requirements for authentication of medicinal products," said Reinhard Hoferichter, chief executive of securPharm in a statement.

Companies who sign up to join securPharm promptly have plenty of time to refine internal processes and the link to the national database - operated by ACS PharmaProtect - before the safety feature requirements come into force in early 2019, he added.

The delegated act is due for official publication this quarter, kicking off a three-year implementation period. After this, only prescription drugs equipped with the new security features may legally be placed on the market.

Earlier this month ACS PharmaProtect implemented a new fee model designed to offer a financial incentive for an earlier entry into the securPharm project.


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