Blue Sphere Health

EMVO Onboarding

If you haven’t heard of  “EMVO Onboarding” yet, it has nothing to do with a Muppet getting on a plane. The European Medicines Verification Organisation (EMVO) is a stakeholder group responsible for the verification system for prescription medicines in Europe. This system, mandated by the Falsified Medicines Directive (FMD) will allow pharmacists to check the DataMatrix “safety feature” on coded packs against a database of authorised codes generated by manufacturers. EMVO is currently onboarding manufacturers (Market Authorisation Holders, MAHs) to their system so they can be ready for the February 2019 deadline stipulated under the FMD.

“My CMOs will take care of that..”

Reporting serialisation data via EMVO is a mandatory legal requirement for all MAHs and can’t be delegated to contract manufacturers (CMOs) or other third parties. No sign-up therefore means no sales. Even completely “virtual” MAHs which don’t manufacture any of their own products have reporting obligations. The process is well-defined but not simple to implement and it requires software and expertise that smaller companies typically don’t have. This is where our EMVO Onboarding service comes in. We will help you to get connected to the EMVO system efficiently so that you can focus on your core business of selling medicines. There are a number of steps involved, in approximately the following order:

Needs Analysis:

We will analyse your requirements and current capabilities and propose a lean, fit-for-purpose solution. We’ll guide you to a tailored User Requirement Specification (URS) describing what you want that system to do. We’ll help you draw up a budget and project plan.

Software:

You’ll need some specific serialisation software, often referred to as a “Level 4” solution. There are a number of providers and we also offer our own cost-effective system. We’ll help you to manage vendor selection and to choose the best approach for your needs and budget.

Implementation services:

We’ll work with the vendor and your internal team to make sure that the software implementation is on time and within budget. We can help with system validation, too.

Onboarding:

We’ll help you with the administration and technical validation of the link between your system and EMVO. You can’t delegate your responsibilities, but you can get help in fulfilling them. Contact Us today to arrange a confidential discussion. February 2019 isn’t far away and a queue is forming for the EMVO process so don’t delay.  

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Pharmaceutical Anti-Counterfeiting

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