EMVO Certifies a Second Gateway Provider

After a series of stringent tests with the European Medicines Verification Organization (EMVO) for connection to the European Hub, Adents has become one of two official “Certified Gateway Providers."

Aug 4th, 2017

As we reported last year, the European Medicines Verification System (EMVS) is a European system designed so that medicines can be verified at the point of dispensing to meet the requirements of the EU Falsified Medicines Directive (FMD).

By February 9, 2019, Marketing Authorization Holders (MAH) that market drug products distributed in the FMD’s jurisdiction will be required to upload their product serialization data on the European Hub. Reporting to the European Hub will entail generating and managing serialization data compliant with each target market.

An On-Boarding Partner (OBP) is a contracting party of the European Medicine Verification Organization. Official OBPs must undergo a series of stringent tests to pass the EMVS certification process. Adents recently announced that it has passed this certification process to become an official OBP (On-Boarding Partner) Gateway Provider, along with TraceLink, which was certified last year.

To achieve certification, Adents co-developed a gateway with Microsoft enabling its Level 4 traceability system, Adents Prodigi, to connect securely with the European Hub.

Adents reports that it is authorized to sign on behalf of Marketing Authorization Holders and transfer their unique identifiers and related information to the European Hub. Adents Prodigi is based on the Microsoft Trusted Cloud Azure platform, which was selected by the EMVO to build the European Hub. Uploading verified and compliant data on the European Hub also means communicating with all national hubs, such as SecurPharm in Germany.

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Check out the links to our coverage of the 2021 PDA Annual Meeting. While the live event has passed, the event site is full of on-demand content covering pharmaceutical filling, supply chain considerations, vaccine manufacturing, and more through May 16.

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No automation needed to be replaced with the switch from PET to aluminum, which was good news for Nature’s Baby. The existing filling line is capable of handling the new aluminum bottles with limited adjustments.

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Nature’s Baby Organics is another recent entry in the shift away from plastic, and toward aluminum, for packaging of personal care and bath products, particularly specialty products with elements like vegan, organic, or cruelty-free.

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Data and AI Accelerate Digital Transformation in Pharma

The PDA Annual Meeting emphasized the growing need for pharma manufacturing facilities to become digitalized to improve productivity, open the door to further technologies, and make the most of the ‘digitally native’ workforce.

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CANnabis or CAN’Tabis: Where is Cannabis Heading Amid New Administration?

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Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.

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Medical Product Changes Stemming from User Centered Design

Live from MD&M BIOMEDigital: a startup, a consultancy, and a large brand owner talk about how interacting with end users changed their medical device and machinery designs.

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There are two categories of cyberattacks, but they can create a bridge to one another, creating a potential avenue for cybercriminals to access the organization.

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5 Tips To Improve Your Remote/Hybrid Audits

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