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Releases

Release 14

2024-05-15

Release 14

The deployment of Release 14 started May 14, 2024 at 23.00 (CET) and was completed at May 15, 2024 at 05.00 (CET).
The release should have no impact on current connectivity to SMVS.

However, a new SMVS API version 3.1 is included, and e-VIS recommends all end users to start using it as soon as possible. As standard, SMVS has 2 releases per year, one in April/May and another in October/November. The plan is that if a new API version is required for a release, it will from now on be made available in the release that takes place in April/May.

NOTE: API version 2.3 will stop working in October/November 2024 and we recommend that end users who are on API 2.3 immediately switch to a later API version.

Changes that impact all version of the SMVS API

  • New operation code to prepare for removal of the Northern Ireland national system (also known as NIXIT) on 1st of January 2025.
    B1020001: ” Produktkoden eller batchen är okänd i det nationella systemet. Databasen som batchen är uppladdad i är permanent bortkopplad från systemet. Förpackningar av batchen kan inte avaktiveras. Verifering eller avaktivering av förpackningen är inte möjlig. “.
    Note: The operation code is included in this release but will not be relevant until after 1st of January 2025 and will then only affect batches that were only uploaded to the Northern Ireland national system.
  • New operation code to be able to handle batches that are exempted from the regulation regarding security details. Each exception will need to be approved by the Swedish Medical Products Agency and the exception will be approved for a specific product at batch level.
    41020006: “Batchen är undantagen från kraven i FMD.”
    Note: This functionality is added in release 14 but its use will be evaluated in 2024.

All available API versions will thus be able to respond with the above operation codes.

New SMVS API version 3.1 is introduced
SMVS API 3.1 brings, among other things, the following changes that may impact the end-user system’s connection to SMVS for those who intend to start using API version 3.1.

  • New fields in the response indicating if the batch has been recalled or if the product has been withdrawn. In cases where a pack is supplied or decommissioned for another reason (e.g. locked or destroyed), today the user does not receive information about whether the batch has been recalled or the product withdrawn but is only informed that the pack has been decommissioned. To address this, two new fields in the responses will be sent to enable the end user to be informed of this, “batchState” and “productState“.
  • New operation codes when the format or length of the batch id does not match:
    41020007, 41020008 and 41020009: ” Batchens identifierare matchar inte den identifierare som produktägaren har angivit. Formatet eller längd på batchen stämmer inte med uppladdad batch. Ett larm har initierats i systemet.”
  • New operation codes when the format or length of the serial number does not match:
    41020010, 41020011 and 41020012: ” Serienumret är okänt. Längden eller formatet stämmer inte med läkemedelsföretagets format. Ett larm har initierats i systemet.”

Other changes in release 14

  • SMVS API 2.4 is set as deprecated but works exactly as usual until it is removed in the release planned for April/May 2025.
    NOTE: SMVS API version 2.3 will stop working in October/November 2024 and we recommend that end users who are on API 2.3 immediately switch to a later version. If you are not sure which version of the SMVS API you are using, you can contact e-VIS and we will help you with this.
  • Further streamlined process for certification where IT suppliers and end users who have logged into the IQE environment will be able to upload test evidence, i.e. test book, screenshots, and log file directly in the SMVS IQE portal.
  • e-VIS will be able to update certain information for an end-user location using the SMVS portal to be able to help support end-users. When a change is made, the end user’s primary contact will receive an email and can then log into the portal and approve/reject the proposed change.
  • When a new location is created, e-VIS will be notified of this directly, which facilitates the periodic self-reporting that takes place periodically.
  • Updated report for the Swedish Medical Products Agency regarding the audit trail of a pack.
  • Minor changes that contribute to better usability, increased security, and system stability.

Information on functionality and current API versions, see Solidsoft ITE Developer Portal (https://developer-ite.nmvo.eu/).

Test environments

  • ITE: SMVS Release 14 is available on ITE since February 19, 2024.
  • IQE: SMVS Release 14 is planned to be available to test on the IQE environment after March 21, 2024.
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