Protection against falsified medicines - Participate in the securPharm project now
Only 852 more days remain until you must have implemented the requirements for protection against falsified medicines in accordance with Directive 2011/62/EU and Delegated Regulation (EU) 2016/161. Pursuant to the legal requirements, the outer packaging of prescription medicines must be equipped with security features. Apart from an anti-tampering device, a unique identifier must be applied to the pharmaceutical package and transmitted to a national data repositories system.
German verification system - ACS PharmaProtect GmbH
In Germany, the unique identifiers are stored in the database system of the pharmaceutical industry (ACS-MAH-system), which is operated by ACS PharmaProtect GmbH.
ACS PharmaProtect GmbH is a wholly owned subsidiary of the three German pharmaceutical associations BAH, BPI and vfa. It is ensured through the shareholders that the interests of the pharmaceutical companies are protected and that a cost-efficient data repositories system is provided.
Connection to the system
During the so-called onboarding (the connection of pharmaceutical companies to the database system of ACS), a contractual distinction is made from technical onboarding. For technical onboarding, the marketing authorisation holders can choose between two options for the data upload. Either marketing authorisation holders can send their data to the EU Hub, which then routes them to the ACS-MAH-system in Germany, or the data are transmitted to the ACS-MAH-system via a direct interface.
A contract with the national verification system is indispensable
Regardless of the technical data transmission, all marketing authorisation holder that placing medicines on the market in Germany and are affected by Directive 2011/62/EU, must conclude a contract with ACS PharmaProtect GmbH. This is done in light of the situation that the data (serial numbers) are stored and kept in the data repositories system for verification through pharmacists and wholesalers.
The contract for IT services
Marketing authorisation holders must go through contractual onboarding and conclude a contract for IT services with ACS PharmaProtect GmbH. The contract for IT services is a standard agreement that can even be concluded before any technical precautions for protection against falsified medicines are taken.
The benefits of joining early
Today, 75 pharmaceutical companies are already connected to the database system of the pharmaceutical industry and benefit from the advantages of early participation. Apart from the opportunity to gather experience the fee model also provides financial incentives for joining early.
To ensure that there is enough time for the testing and trial phase, we strongly recommend you participate in the securPharm project in order to safeguard that your products remain marketable past the effective date of 9 February 2019. If you have any questions on the terms of participation, please contact our Customer Recruitment & Relationship Management Team:
Mrs Maria Mehnert
Customer Recruitment- & Relationship Management
Office +49 30 577 037 907
Mr Tobias Beer
Head of Customer Recruitment- & Relationship Management
Office +49 30 577 037 902