E-verification in Sweden - experience from first 7 weeks and next step

First of all we would like to conclude that the start of e-verification in Sweden has gone well. The Swedish system has been functional during the first few weeks. Pharmacy and wholesalers use the system routinely since February 9 - we see daily that the transactions in the system are increasing, which indicates that the number of packs with 2D codes on the market are increasing and that pharmacies and wholesalers increase their scanning.

Next step - continued stabilisation period
Learn MoreContinued stabilisation period
 

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.

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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. All paticipants in the supply chain of medicines are concerned . This places great demands on all participants in the supply chain,

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SMVS

SMVS is the Swedish national system for the verification and decommisioning of products in scope of the Delegated Regulation 2016/161. The SMVS is part of the European Medicines Verifications System (EMVS). Follow changes in the status.

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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, including a large amount of relevant documents.

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