German verification system sets deadline for timely connection in September
ACS PharmaProtect GmbH (ACS) as the operator of the database system of the pharmaceutical industry is a substantial part of securPharm, the German protective shield to prevent the entry of counterfeit drugs into the legal supply chain according to the requirements of the Falsified Medicines Directive 2011/62/EU and the Delegated Regulation 2016/161 (EU).
So far, ACS has 224 contract partners. From the beginning we ensured the smoothest possible and timely conclusion of a contract as well as the technical connection for our customers. To this end, ACS works closely with securPharm e.V., the pharmaceutical associations in Germany and the European Medicines Verification Organisation (EMVO) to guarantee the greatest possible flow of information. However, it remains the sole responsibility of the pharmaceutical companies to meet the requirements and to take all necessary measures to meet the legal requirements in time until February 9, 2019.However, ACS will not be able to provide the same level of end-to-end support and technical connectivity support when many of the not connected pharmaceutical companies decide not to contact ACS until the last quarter of 2018. Therefore, we set the deadline for a timely conclusion of the contract on September 30, 2018. For contracts concluded before this deadline, ACS ensures the connection before February 9, 2019, if all contractual and technical conditions exist. For contracts after this deadline, ACS will strive for a timely connection, but this cannot be assured. Any late conclusion of the contract after this date may therefore pose a risk to the business of the pharmaceutical company. The entire onboarding process (contract conclusion and technical connection) requires great care from ACS and therefore also some time.
Since 2013, the internal processes of serialization with the ACS-MAH system have been tested in practice, currently a unique selling point in the EU. The pack-related data on their medicinal products requiring serialization can be uploaded to the database system of ACS via the national access directly or via the EU Hub, of which the EMVO is the operator.
For more information, contact ACS PharmaProtect at firstname.lastname@example.org or phone +49 30 577 037 900.
For reasons of interoperability with other data storage systems of the data storage and retrieval system, it is necessary for you, as a pharmaceutical company, also to sign a contract with EMVO. Therefore, we recommend that you turn to the topic in good time. A letter from EMVO can be found on our website (www.pharmaprotect.de)
With best regards,