The soft launch of the medicines verification system will end on January 31st 2020

The number of alerts has already fallen to a low level (on average, one alert per 1000 verified packages). End users have gained experience with the operation of the system and the resolution of various alerts and error situations.

In practice, the soft launch has meant that pharmacies, hospital pharmacies, and dispensaries have not needed to respond to an alert from the medicines verification system if:

1. The batch has been released before February 9th 2019, AND
2. The cause of the alert is unknown product code OR missing batch information OR expiry date mismatch

In this context, it is particularly important to note that batches released after February 9th 2019 were never covered by the soft launch. All batches released after this date must include the safety features required by the Delegated Regulation 2016/161 and must be uploaded to the medicines verification system before release for distribution. Likewise, any alerts caused must be resolved.

The end of the soft launch is unlikely to cause a major increase of verification alerts for pharmacies, hospital pharmacies, or dispensaries. There are several reasons for this:

1. Pharmaceutical wholesalers, according to current information, will continue to voluntarily verify the new batches they receive.
2. Many batches that were covered by the soft launch have been or will be sold out before the end of the soft launch.
3. In addition, alerts caused by non-serialized and / or products out of scope will be prevented in the future by technical modifications to the FiMVS system.

The most significant change is in principle. That is, after January 31st 2020, all alerts in the medicines verification system must be resolved before the alerting pack can be dispensed to the patient. Another relevant change is that unknown product code no longer creates an alert, only an exception.

More information can be found in material from our last workshop that was held in November 2019: https://www.laakevarmennus.fi/en/news/mah-workshop-5th-november-presentations

Please send all queries regarding alerts to our email address: nmvs@fimvo.fi

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