FMD

EMVO Encourages Early Onboarding to Avoid Bottleneck Situations

The Adents Team Written by The Adents Team
03-Jan-2018

The European Medicines Verification Organization (EMVO) encourages pharmaceutical companies to set up their connection with the EU Hub as soon as possible to avoid bottleneck situations.

For compliant reporting of serialization data, OBPs need to connect to the EMVS (European Medicines Verification System). According to EMVO’s definition, an OBP (onboarding partner) “is a legal entity that is part of a Corporation or a Group and will send data to the EU Hub on behalf of Marketing Authorization Holders that are also part of that corporation”. In short, this means an entity of a pharmaceutical group or company that centralizes all serialization data and reports it in the required format to the relevant European authority (through the Hub). Said entity can either develop its own connection (or gateway as the EMVO calls it) to the Hub or go through a Certified Gateway Provider to avoid the hassle of in-house development.

EMVO updates pricelist to incentivize early onboarding

You can imagine that if everybody tries to hook up to the European Medicines Verification System (EMVS) at the same time, this will lead to bottleneck situations as vast amounts of paperwork needs to be processed, OBPs authenticated and connections tested. Bottleneck situations, however, can be avoided through early onboarding (before it becomes mandatory in February 2019). This is expressly encouraged by the European Medicines Verification Organization (EMVO) and reflected in its recent update of onboarding fees:

EMVO pricing chart update

Image source: https://emvo-medicines.eu/wp-content/uploads/2017/08/15.12.2017_-Letter-of-Announcement_On-boarding-Fee.pdf

Speed up the onboarding process with certified gateway providers

In order to speed up the connection process, pharmaceutical companies can choose to connect to the EU Hub via Certified Gateway Providers like Adents. With Adents Prodigi, pharmaceutical companies can ensure connectivity to the EU Hub and compliant reporting of correct data in the correct format without having to invest in lengthy in-house development.

Compelling reasons for early EMVS reporting

A part from the financial incentive there are further good reasons for early reporting:

Products expiring after February 2019 might be dispensed when the FMD (Falsified Medicines Directive) requirements will be in effect. This means that companies will probably have to start serializing (and therefore reporting – or at least storing serialization- and product master data until February 2019 to enable reporting and verification afterwards). Secondly, early reporting means testing all functionalities and reporting capabilities of a serialization solution in a low-pressure mode, giving an added buffer zone for trial and error.

In addition to a functional connection to the European Hub or EMVS, Adents Prodigi provides reliable connectivity with all your trading partners, centrally manages all your serial numbers and comes with enhanced features for value beyond compliance. Need more info? Get in touch!

 

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The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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