On April 10, 2018, e-VIS received approval from EMVO (European Medicines Verification Organization) and was connected to the production environment in the EMVS. This is an important milestone for Sweden to be able to support the EU Directive 2011/62/EU on Falsified Medicines. Sweden together with Slovenia, Ireland and Denmark are among the first countries to receive production approval.
e-VIS could not have reached this milestone without active support from the many stakeholders involved and without close and good cooperation with the other countries with the same blueprint provider

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Background

The Falsified Medicines Directive prescribes mandatory, harmonised safety features on all human prescription medicines packs (with certain risk-based exceptions) marketed in the EU. These safety features shall consist of a unique identifier combined with an anti-tampering device for each pack. The information about the safety features will be stored in a database and each pack must be verified in connection with dispensing to the customer/patient. The goal is to prevent falsified medicines from reaching patients through the legal supply chain.

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Pharmaceutical companies (MAHs)

Many preparations are needed in order for companies and other stakeholders to meet the requirements of the directive in February 2019. A large number of packs, systems and procedures are involved. It is therefore crucial to plan and prepare implementation as much as possible. A great deal of this work should have been started already or must be started urgently.

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Pharmacies/Wholesalers

The requirements apply beginning on Feb. 9, 2019 when marking of packaging and IT systems for verification must be fully implemented. This places great demands on all participants in the supply chain, Each pharmacy and wholesaler must be aware of what is required of them for a successful implementation before February 9, 2019.

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EMVO

The European Medicines Verification Organisation (EMVO) has taken responsibility for advancing the formation of the European Medicines Verifications System (EMVS). The EMVS is in accordance with the EU’s Falsified Medicines Directive (FMD) and Delegated Regulation (DR) and ensures the implementation of a functioning, secure, interoperable and cost effective system across Europe.

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Q&A

Deployment of a new pharmaceutical services system requires changes in many different systems and methods. Below are answers to some of the questions that e-VIS and the implementation project have received. (NTIN to GTIN, Costs, Tests, Contracts, etc.).

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