FiMVO Newsletter 3-2019

Practice went well - now time to switch up a gear!

Soft launch period will end by the end of Sep 2019

The use of medicines verification has worked well throughout the spring. The number of packs in the system is increasing all the time, the accuracy of the data improving, and the errors by the users are reducing.

However, everyone still needs to step up in order to reach a sufficiently low level of alerts. We must all invest in this now, because the soft launch of the system will be stopped by the end of September.

This means that from October onwards, all alerts generated in the system must be investigated before the medicine is delivered to the patient. The number of alerts is now stabilizing but will only fall to an acceptable level after every last cog in the wheel is oiled. We have informed also the Finnish NCA Fimea about the end of the soft launch.

The rest of Europe is also preparing to end the soft launch periods with slightly differing dates in the end of the year.

 

What the end of the soft launch requires from the pharmaceutical distribution chain

After 30 Sep 2019 all FiMVS system alerts must be investigated. A medicinal product can only be dispensed after the possibility of a suspected falsification has been ruled out.

We recommend users to document this investigation in such a manner that the justification for the dispensing of the alerting pack can be verified afterwards.

Alerts raised by FiMVS include:

  1. Unknown product code
  2. Missing batch
  3. Expiry date mismatch
  4. Unknown serial number
  5. Batch mismatch
  6. Pack is inactive
  7. Pack status does not match the undo transaction (e.g. pack status is FREESAMPLE and the user tries to perform an Undo dispense -transaction)

In addition, if pack data has not been uploaded in FiMVS, but can be found in another EU NMVS (e.g. medicinal products with special permission for compassionate use, which have a MA in another EU country), FiMVS may raise the following alerts:

  1. Property is already set on pack (essentially corresponding to “Pack is inactive” alert)
  2. Defined timeframe between setting this property and the undo was exceeded (more than 10 days, i.e. 240 h)
  3. Undo can only be executed by the same user who previously set the attribute

NOTE. If the pack data has been uploaded in FiMVS, return messages 8 and 9 above do not raise an alert, only an exception message that the timeframe has been exceeded or that another user has performed the original transaction. Even in this case the user will be unable to perform the undo transaction.

Users should also note that if they inadvertently try to dispense a pack previously dispensed by the same user, FiMVS returns an exception telling that the user has already dispensed the pack (double dispense exception). This is not an alert. FiMVS gives this exception three times before raising the “Pack is inactive” alert.

Furthermore, it should be noted that product and batch data of medicinal products imported to Finland outside the EU with a special permission for compassionate use have not been uploaded to EMVS even though the packs may visually resemble EU serialized products and carry a similar 2D data matrix. Users do not have to verify these products. In case of uncertainty it is recommended to contact the distributor/importer for confirmation.

Causes of the most common user-related false alerts

  1. Scanning of the 2D data matrix fails > characters are missing from the batch ID or serial number OR additional characters have been merged to batch ID or serial number (usually the EAN code or part of it)
  2. Scanning of the 2D data matrix fails > barcode scanner changes capital letters in the batch ID or serial number to small letters or vice versa OR special characters in the batch ID or serial number (hyphen, dot, slash…) to other characters

If FiMVS returns any alert caused by a data error (alerts 1-5 listed previously) the user should first review the data included in the system query and compare this data with the data printed on the pack. Based on this review it is in most cases possible to identify the incorrect data in the query.

If the data in the original system query does not correspond to the pack data as described in point 1 above, the 2D data matrix can be re-scanned. If scanning still fails it is advisable to try another barcode scanner or enter the data manually. In this context it should be noted that the barcode scanner may read the EAN code after the 2D data matrix and attach this data to the data contained in the 2D data matrix, if 2D data matrix and linear barcode (EAN code) are placed close to each other on the same side of the pack. In these cases, it may help to cover the linear barcode when reading the 2D data matrix.

If the barcode scanner changes characters to other characters as described in point 2 above, re-scanning the 2D data matrix does not change the outcome. The barcode scanner must be re-configured or changed to another, correctly configured one. If this is not possible right away, pack data can be entered manually. If needed, the user may contact the support of their IT provider.

It should also be noted that Article 29 of the Delegated Regulation 2016/161 allows a pack to be dispensed even if the verification and decommissioning of the pack is not possible due to technical reasons. In such a case the user must record the pack data and verify and decommission the pack as soon as the technical issues have been corrected.

In order to avoid any problems in the supply chain and the availability of medicinal products as a result of the ending of the soft launch in Finland, marketing authorisation holders should pay special attention to the procedures they have in place for ensuring the successful uploading of product and batch data in FiMVS and the correctness of the data. If there is uncertainty whether the data has been completely and correctly uploaded in FiMVS, FiMVO may be contacted for confirmation. We also recommend that manufacturers/marketing authorisation holders ensure that the data printed on the 2D data matrices of the packs is in line with the data uploaded in FiMVS and 2D data matrices have the technically correct structure. This can be ensured by verifying by scanning the 2D data matrix of at least one pack before shipping the product batch further.

Manufacturers/marketing authorisation holders are advised to pay attention to the following issues:

  • Expiry date printed on the packs should be the same as the expiry date encoded in the 2D data matrix and uploaded to FiMVS
  • It is recommended to place the 2D data matrix on another side of the pack than the linear barcode (EAN code), if EAN code is still needed on the pack
  • MAH should notify the supply chain of the importing of the first serialized batch of a product to Finland by completing the serialization notification in Vnr web service and it is important that this notification also contains the correct expiry date of the first batch
  • If companies still have non-EU-serialized batches (so called India packs, which visually resemble EU-serialized packs) in the supply chain, they should inform FiMVO and supply chain actors of these batches, because these packs may cause false system alerts in FiMVS

Join our workshops!

We are organising a workshop for MAHs on Wednesday 12th June, starting at 10:00. Please find more information on our website https://www.laakevarmennus.fi/en/news/agenda-our-mah-workshop-12th-june . Please register at info@fimvo.fi .

For the pharmacies and wholesalers we have an event on Thursday 13th June starting at 13:00. The agenda is on our website https://www.laakevarmennus.fi/uutiset/workshop-laakevarmennusjarjestelman-loppukayttajille-136-ohjelma-julkaistu-huomaathan . The End User even will be held in Finnish. Please register at info@fimvo.fi .
 

Personnel Changes

Our Operations Manager, Tero Vesa, will leave FiMVO on 11.6. and for now, FiMVO will be operating with reduced staff.

Contacting us:

When you email us regarding queries about our system, please use nmvs@fimvo.fi. All the team has access to this mailbox. Using the NMVS email will ensure that your message reaches us as quickly as possible.

FiMVO’s summer

 

FiMVO’s summer holiday season contact people are as follows:

    • 10.-28.6.2019 Maija Gohlke-Kokkonen & Teijo Yrjönen
    • 29.6.-7.7.2019 Teijo Yrjönen
    • 8.-28.7.2019 Maija Gohlke-Kokkonen
    • 29.7.-4.8.2019 Maija Gohlke-Kokkonen & Teijo Yrjönen
    • 5.-11.8.2019 Maija Gohlke-Kokkonen
    • 12.-25.8.2019 Teijo Yrjönen

Contact us:

General Manager: Maija Gohlke-Kokkonen - maija.gohlke-kokkonen@fimvo.fi
Phone +358 40 700 1655

 

QA Manager: Teijo Yrjönen - teijo.yrjonen@fimvo.fi 
Phone +358 50 573 3421


Communications Assistant: Katriina Newton-Kolehmainen - katriina.newton-kolehmainen@fimvo.fi

Phone +358 50 598 6857

www.fimvo.fi

Twitter: @fi_mvo

LinkedIn: https://www.linkedin.com/company/fimvo-finnish-medicines-verification-o…

 

THE FIMVO TEAM WISHES YOU A LOVELY AND SUNNY SUMMER!