RegulatoryOfficial

Slovakia tightens supply-interruption reporting for MAHs from 1 November, with 60-day notice validity

🇸🇰 ŠÚKL · Wed 28 Oct 2026

An amendment to Act No. 362/2011 Coll. limits the validity of supply-interruption notifications to 60 days and requires MAHs to restate reasons and expected restocking dates when re-notifying.

Slovakia's medicines agency ŠÚKL has set out how marketing authorisation holders must notify interruptions and cessations of human medicine supply once an amendment to Act No. 362/2011 Coll. takes effect on 1 November 2026. The notice was published on 28 October.

Under Section 60(1)(i)(2), MAHs must notify an interruption or cessation, with reasons, before it happens or without delay after they learn of it. For interruptions, a notification is valid for a maximum of 60 days. When an MAH files a repeat notification, it must again give the reasons for unavailability together with an estimated date for supply to resume.

The 60-day period runs from the effective date of the notification, meaning the date from which the product becomes unavailable on the market. Where an interruption is only expected, the MAH must monitor availability and report any unexpected change without delay through a new notification on the interruptions portal, with the reason given in a note. The original notification will be rejected. Planned interruptions or cessations must still be notified at least two months in advance under Section 60(1)(i)(3).

ŠÚKL said further details on repeat notifications after the 60 days have elapsed will be provided during November 2026, because the portal is still being prepared. Only notifications submitted after 1 November will be subject to inspection. Notifications filed before the amendment took effect do not need to be resubmitted. Reports on first marketing, resumption or cessation of supply continue unchanged.

The agency also noted that the portal for reporting imports and consumption of medicines remains temporarily unavailable owing to a global security situation involving critical PHP flaws. The interruptions portal is working again. As a result, validation of first-marketing notifications is currently not possible. Queries can be sent to prerusenie@sukl.sk.

What it means for your team

  • Review Slovak shortage-notification procedures so that interruption notices are renewed within the 60-day validity window, restating reasons and the estimated resumption date.
  • Build in monitoring of expected interruptions: an unexpected change in availability needs a new portal notification with a note on the reason, and the original will be rejected.
  • Keep the two-month advance notice for planned interruptions or cessations, which is unchanged.
  • Watch for ŠÚKL's November guidance on repeat notifications beyond 60 days, and note that first-marketing notifications cannot currently be validated.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

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