ISZP - The Day After

Act No. 375/2022 Coll., on MDs and IVDs, stipulates that distributors and service providers listed in the Information System of Medical Devices (ISZP) must submit a change notification or confirm the accuracy of their data at least once a year—provided no changes occurred during the year. Otherwise, their activity in IZSP will be invalidated. Since ISZP has been launched in early March 2024, the first deadline to confirm data accuracy came at the beginning of last month.

Affected entities received a reminder from the State Institute for Drug Control (SUKL) two months before the deadline expired, and we also covered this in our February Newsletter. Still, you may have missed the deadline for various reasons. If, despite the information above, your activity in ISZP has now become invalid, here is our advice on how to restore it.

We have one good news and one bad news. The bad news is that you may receive a fine from SUKL—up to CZK 500.000. Therefore, we advise addressing the problem without delay. The good news is that the Act on MDs and IVDs recognizes the concept of “revival of notification.” Upon request of the subject concerned, invalidated data can be restored within six months from their invalidation date. This is especially helpful if you have a broad distribution portfolio. Restoration requires a fee of CZK 1.500. More information and a detailed guide are available on SUKL’s website here.

Once you’ve solved the immediate problem of invalidated notification, it’s time to take preventive action. You need to answer the question of what caused the deadline to be missed. Did SUKL’s reminder end up in the email inbox of a colleague who no longer works with you? Ask SUKL to update the contact details. Did you leave the confirmation of correctness to the last minute and subsequently did not manage to set up ISZP access in time? Or did a technical problem occur, for example a system outage or delayed internal communication, that you couldn’t resolve in time?

Next time, as soon as you get the reminder from SUKL, check your ability to log into the ISZP and don’t leave the confirmation of your data for the last day of the deadline. If you follow these simple rules, you should avoid similar issues next year and spare yourself unnecessary complications and costs.

Please do not hesitate to contact us if you need help with navigating the ISZP and the subsequent procedure.

Author: Veronika Moravová