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)

As of 9 February 2019, marketing authorised holders are obliged to place two safety features on the packaging of most prescription medicines and some over-the-counter medicines in the European Union: a unique identifier (a 2-dimension barcode) and an anti-tampering device, in accordance with Commission Delegated Regulation (EU) 2016/161. The goal is to prevent falsified medicines from reaching patients through the legal supply chain.

Each MAH which markets at least one product within a national territory must have a contract with the National Medicines Verification Organisation (NMVO) and pay the national fee.

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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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