We are getting close to 9 February 2019 and urges all who are going to onboard the Swedish system (pharmacies/wholesalers) to send in the form as soon as possible (see link below if you need to onboard or not). Since many organisations are expected to onboard we can see that many applications will come in January and February. We will do our utmost to see to it that all that has applied will have a connection by 9 February 2019 – but to guarantee a connection the form needs to be sent in at the latest 11 January 2019. Requests for onboarding sent in later than 11 January will be handled in terms of time.

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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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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. (NTIN to GTIN, Costs, Tests, Contracts, etc.).

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