Slovakia SUKL is an official public source that HealthSignal monitors for Pharmaceuticals. The most recent updates we have tracked from it are listed below, each normalised into our index and linked back to the original publication on the source's own website.
Guidance on proper and complete data entry and document submission for economic operator registration in EUDAMED to expedite registration and assignment of Single Registration Number.
Slovakia SUKL · SlovakiaGuidance on procedures for submitting applications to register as a distributor of medical devices and in vitro medical devices.
Slovakia SUKL · SlovakiaNew edition of Slovak Pharmaceutical Code published 15 July 2026, updating national requirements and incorporating European Pharmacopoeia standards for compounded medicines.
Slovakia SUKL · SlovakiaPublic consultation on proposed new and revised European Pharmacopoeia articles open until 30 September 2026.
Slovakia SUKL · SlovakiaProcedural guidance for applicants seeking to obtain, modify or revoke special permits to handle drug precursors in pharmacies with individual medicine preparation.
Slovakia SUKL · SlovakiaProcedural guidance on submitting applications for authorisation to handle Category 1 designated substances under Slovak law 331/2005.
Slovakia SUKL · SlovakiaProcedural guidance on submitting applications for registration to handle designated substances under Slovak law 331/2005.
Slovakia SUKL · SlovakiaGuidance on how to submit registration documentation for human medicines to the Slovak medicines authority.
Slovakia SUKL · Slovakia18.06.2026| Nezaradené|Podávanie dokumentácie|Podávanie žiadostí a dokumentácie na SRL|Registrácia humánnych liekov|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaEstablishes a uniform procedure for marketing authorisation holders to submit and distribute medicine shortage communications (MSC) to healthcare professionals.
Slovakia SUKL · Slovakia27.05.2026| Oznam|Aktuálne informácie|Zdravotnícke pomôcky|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaGuidance for pharmaceutical care providers on handling Category 1 drug precursors in individual medicine preparation, including conditions for issuing, amending or revoking special authorisation in connection with upcoming European legislation changes.
Slovakia SUKL · SlovakiaConference module on updates in medical devices and ongoing changes to Slovak national legislation (Act 362/2011).
Slovakia SUKL · SlovakiaStručné zhrnutie záverov zo zasadania Výboru pre hodnotenie rizík liekov (PRAC), ktoré sa uskutočnilo 8.–11.6.2026. Plné znenie správy sa nachádza nawebovej stránke Európskej liekovej agentúry.
Slovakia SUKL · SlovakiaSummary of conclusions from the PRAC meeting held 6–9 July 2026; full report available on the European Medicines Agency website.
Slovakia SUKL · SlovakiaSUKL website access from foreign IP addresses temporarily restricted for cybersecurity protection and server stability.
Slovakia SUKL · SlovakiaKomplexný prehľad činností Štátneho ústavu pre kontrolu liečiv za rok 2025 vrátane výsledkov práce jednotlivých sekcií a oddelení, odborných a medzinárodných aktivít a hospodárenia inštitúcie.
Slovakia SUKL · SlovakiaSlovak medicines regulator warns of risks from improper medicine storage during high temperatures, including in self-service dispensing boxes and direct sunlight.
Slovakia SUKL · Slovakia22.06.2026| Aktualita|Poplatky|Podávanie žiadostí a dokumentácie na SRL|Registrácia humánnych liekov|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaSUKL experienced a technical error causing duplicate emergency notifications to be sent; duplicates should be ignored.
Slovakia SUKL · SlovakiaDirect Healthcare Professional Communication issued for Evrysdi (risdiplam) 0.75 mg/ml regarding new important safety, efficacy or use information.
Slovakia SUKL · SlovakiaDirect healthcare professional communication issued regarding new important safety, efficacy or proper use information for Evrysdi.
Slovakia SUKL · SlovakiaOne batch of LIBTAYO 350 mg concentrate for infusion (batch 8496700006, expiry 31 July 2027) withdrawn from distributor level due to suspected incomplete closure defect.
Slovakia SUKL · SlovakiaNew liver function monitoring requirements imposed for cenobamate (ONTOZRY) following reports of serious hepatic injury.
Slovakia SUKL · SlovakiaBatch 10825 (expiry August 2027) of Levosimendan FMK 2.5 mg/ml withdrawn due to presence of particles in solution.
Slovakia SUKL · SlovakiaDirect healthcare professional communication issued regarding a discrepancy in the written patient information for ENDITRIL (racecadotril).
Slovakia SUKL · SlovakiaOne batch of Bendamustine Glenmark 2.5 mg/ml (batch 2500143, expiry November 2026) withdrawn due to active substance content outside specification limits.
Slovakia SUKL · SlovakiaNitrofurantoin Pharmevid has been withdrawn from the market.
Slovakia SUKL · SlovakiaImuldosa has been withdrawn from the market.
Slovakia SUKL · SlovakiaUsymro has been withdrawn from the market.
Slovakia SUKL · SlovakiaDirect Healthcare Professional Communication on new safety information regarding meningioma risk with desogestrel and etonogestrel-containing medicines.
Slovakia SUKL · SlovakiaMedicine Veral has been withdrawn from the market.
Slovakia SUKL · SlovakiaImuldosa has been withdrawn from the market.
Slovakia SUKL · SlovakiaMedicine Veral has been withdrawn from the market as of 1 June 2026.
Slovakia SUKL · Slovakia