Swedish Medicines Verification System (SMVS)

SMVS is the Swedish national system for the verification and decommissioning of products in scope of the Delegated Regulation 2016/161. The SMVS is part of the European Medicines Verification System (EMVS) which is composed of a central European hub and connected national systems, in principle one for each country. The main purpose of the national systems is to serve as the verification platforms that pharmacies, wholesalers and other required parties in that country can use to check a product’s “authenticity”. All data necessary to perform this and other relevant transactions are stored in the respective national systems. The main purpose of the European Hub is to serve as a gateway for the transmission of manufacturer and parallel distributor data to the national systems.

Status

Release (4.1) is implemented to correct known, documented deviations and requested minor changes/additions and contains:

  • 14 corrections, ie. reports which are not correct, messages with inaccurate translation, inaccurate handling of codes in IMT (Imtermarket Transactions, adjustments after security audit
  • Some changes, of which 4 are connected to safety and performance improvements and 2 to reports, ie. access to ”Contracted WS stakeholder report” for clients in National systems  system

12 December 2018
SMVS has been updated to version 4.0. SMVS now fully supports the verification and decommissioning of multi market packs by ensuring proper status throughout the European system. MAH can now also recall batches in the national markets. A web interface is available for pharmacies and distributors to enable and disable packaging by manual entry in case of emergency, if your own system for some reason does not work. A number of new reports are now also available to different users of the system. Additionally, user notifier functionality has been developed to enable e-VIS to notify portal users directly through the portal.

30 September 2018
Version 3.0 of SMVS is now available with enhanced functionality. Pharmacies and Wholesalers now have possibility to create reports via a new API. The portal used by pharmacies and wholesalers have new functionality for handling of roles and responsibilities, together with handling of clent ID and password for the technical connection to SMVS. The interface for manufacturers via the Hub has been updated so that they can verify the status of the packages in SMVS, recall batch and programmatically call SMVS via an API to get reports about their packages that are in the SMVS. A number of new reports are available for the different stakeholders.

6 July 2018
SMVS is now updated to Release 2.0 with enhanced functionality. Pharmacies and Wholesalers can download Product Master Data for products available in SMVS. MAH can update the status on earlier uploaded packages. If products are to be sold on more than one market the status changes will be synchronised to make the information up-to-date. See below a table presenting the new functions.

25 May 2018
Release 1.1.2 fixes two problems concerning the upload of packages into SMVS from EU-Hub. Firstly a problem with an alert (duplicate pack alerts) sometimes was created during uploading of packages despite no such error occurred and secondly problems that only parts of the packages intended were uploaded.

18 May 2018
Release 1.1.1 fixes a problem concerning certain special characters (specified in GS1 Character Set 82) in batch id were not uploaded correctly into from EU-Hub.

10 April 2018
e-VIS is approved by the European organisation, EMVO, and can be connected to the production environment of EMVS. It is now possible to upload data to the EU-Hub for products intended for the Swedish market.


Information

Latest updated:
7 February 2019


Documents, links