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 · SlovakiaCommission Delegated Regulation (EU) 2024/1701 amending Regulation (EC) No 1234/2008 on changes to marketing authorisation conditions for human medicines enters into force on 1 January 2025, with updated CMDH guidelines and EMA guidance.
Slovakia SUKL · SlovakiaFrom 15 January 2026, all applications for changes to human medicinal product registrations must follow updated CMDh/EMA classification guidelines for variation categories 1A, 1B and II.
Slovakia SUKL · SlovakiaGuidance on procedures for submitting applications to register as a distributor of medical devices and in vitro medical devices.
Slovakia SUKL · SlovakiaInstructions for completing the adverse reaction reporting form TL SV OF 006, including case description, investigations, treatment and submission procedures.
Slovakia SUKL · SlovakiaInstructions for completing the adverse event reporting form for suspected vaccine side effects, including case description, investigations, treatment and submission procedures.
Slovakia SUKL · Slovakia20.08.2026| Nezaradené|Postregistračné procesy|Registrácia humánnych liekov|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaŠÚKL clarifies that requests to revoke medicine registrations must include payment of a fee according to the fee schedule effective from 1 January 2020.
Slovakia SUKL · Slovakia18.06.2026| Nezaradené|Podávanie dokumentácie|Podávanie žiadostí a dokumentácie na SRL|Registrácia humánnych liekov|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaGuidance on how to submit registration documentation for human medicines to the Slovak medicines authority.
Slovakia SUKL · SlovakiaCurrent issue of Pharmeuropa (38.3) open for comment until 30 September 2026.
Slovakia SUKL · SlovakiaGuidance on applications for permits to handle, modify or revoke permits for Category 1 designated substances under Act No. 331/2005.
Slovakia SUKL · SlovakiaGuidance on registration procedures for handling Category 2 and 3 designated substances under Slovak law 331/2005.
Slovakia SUKL · SlovakiaGuidance for applicants seeking to obtain, modify or revoke special permits to handle drug precursors in pharmacies with individual medicine preparation.
Slovakia SUKL · SlovakiaEstablishes a uniform procedure for marketing authorisation holders to submit and distribute medicine shortage communications (MSC) to healthcare professionals.
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 · Slovakia27.05.2026| Oznam|Aktuálne informácie|Zdravotnícke pomôcky|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaConference module on updates in medical devices and ongoing changes to Slovak national legislation (Act 362/2011).
Slovakia SUKL · SlovakiaEducational television series launched by Slovakia's medicines regulator in 2025 to provide practical guidance on correct medicine use and health misinformation.
Slovakia SUKL · SlovakiaPharmacies must dispense pseudoephedrine-containing medicines only in quantities needed for one treatment cycle when not requiring a prescription.
Slovakia SUKL · SlovakiaŠÚKL updates the procedure for revoking medicine registrations, requiring advance payment of revocation fees from 1 June 2020.
Slovakia SUKL · SlovakiaPrehľad registrovaných liekov s obsahom pseudoefedrínu s výdajom bez lekárskeho predpisu 19.08.2026| Nezaradené|Registrované lieky s obsahom drogového prekurzora|Drogové prekurzory|Pre odborníkov a firmy
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 · SlovakiaNew edition updates national requirements and includes translations from the European Pharmacopoeia for individually prepared medicines.
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 · Slovakia22.06.2026| Aktualita|Poplatky|Podávanie žiadostí a dokumentácie na SRL|Registrácia humánnych liekov|Pre odborníkov a firmy
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 · SlovakiaConference on medicine registration and pharmacovigilance activities, including changes to Slovak pharmaceutical legislation (Act 362/2011), scheduled 14 October 2026.
Slovakia SUKL · SlovakiaSUKL experienced a technical error causing duplicate emergency notifications to be sent; duplicates should be ignored.
Slovakia SUKL · SlovakiaFingolimod Zentiva is being withdrawn from distribution companies, pharmacies and healthcare facilities with class II urgency.
Slovakia SUKL · SlovakiaDirect Healthcare Professional Communication issued for Evrysdi (risdiplam) 0.75 mg/ml regarding new important safety, efficacy or use information.
Slovakia SUKL · SlovakiaRowatinex is being withdrawn from distribution companies, pharmacies and healthcare facilities with class II urgency.
Slovakia SUKL · SlovakiaTamoxifen 10 mg and 20 mg tablets: supply disruption notification to healthcare professionals.
Slovakia SUKL · SlovakiaDirect Healthcare Professional Communication issued with updated safety recommendations for ritlecitinib regarding cardiovascular events, malignancy, thromboembolism, infections and mortality.
Slovakia SUKL · SlovakiaZoely is being withdrawn from distribution companies, pharmacies and healthcare facilities with class II urgency.
Slovakia SUKL · SlovakiaDirect healthcare professional communication issued regarding new important safety, efficacy or proper use information for Evrysdi.
Slovakia SUKL · SlovakiaNew liver function monitoring requirements imposed for cenobamate (ONTOZRY) following reports of serious hepatic injury.
Slovakia SUKL · SlovakiaDirect healthcare professional communication issued regarding a discrepancy in the written patient information for ENDITRIL (racecadotril).
Slovakia SUKL · SlovakiaLIBTAYO 350 mg concentrate for infusion solution has been withdrawn from the market.
Slovakia SUKL · SlovakiaLevosimendan FMK has been withdrawn from the market.
Slovakia SUKL · SlovakiaBendamustine Glenmark has been withdrawn from the market.
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