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 · SlovakiaFrom 28 May 2026, device notification and ŠÚKL code assignment requests are processed in standard 30-day timeframe; expedited processing is discontinued.
Slovakia SUKL · SlovakiaGuidance on procedures for submitting applications to register as a distributor of medical devices and in vitro medical devices.
Slovakia SUKL · SlovakiaGuidance on how to submit proposals for development or revision of European Pharmacopoeia monographs or general chapters to the European Pharmacopoeia Commission.
Slovakia SUKL · SlovakiaInformation on influenza vaccines available in Slovakia for the 2026/2027 season and guidance on adverse event reporting.
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 · SlovakiaPharmeuropa 38.3 is open for comment until 30 September 2026.
Slovakia SUKL · SlovakiaInstructions for completing the adverse event report form TL SV OF 007 for suspected adverse events associated with vaccination.
Slovakia SUKL · Slovakia20.08.2026| Nezaradené|Preskúmanie zmien podmienok povolení na uvedenie liekov na humánne použitie na trh|Postregistračné procesy|Registrácia humánnych liekov|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaInstructions for completing form TL SV OF 006 for reporting suspected adverse drug reactions.
Slovakia SUKL · Slovakia20.08.2026| Nezaradené|Postregistračné procesy|Registrácia humánnych liekov|Pre odborníkov a firmy
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 · SlovakiaGuidance on registration procedures for handling Category 2 and 3 designated substances under Slovak law 331/2005.
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 · Slovakia20.08.2026| Nezaradené|Zrušenie registrácie lieku|Postregistračné procesy|Registrácia humánnych liekov|Pre odborníkov a firmy
Slovakia SUKL · SlovakiaThe European Pharmacopoeia sets technical requirements for preparation, manufacture, labelling, storage and quality assessment of medicinal products and excipients.
Slovakia SUKL · SlovakiaThird updated edition of the Slovak Pharmaceutical Codex entered into force on 15 July 2026, aligning requirements with European Pharmacopoeia standards for preparation, testing, labelling, storage and dispensing of medicines.
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 · SlovakiaApplications submitted after 1 June 2006 must include a declaration on how written information will be made accessible to the blind.
Slovakia SUKL · SlovakiaSUKL invites expert feedback on the third edition of the Slovak Pharmaceutical Codex, which entered into force on 15 July 2026, to identify gaps and user expectations.
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 · Slovakia25.09.2026| Článok|Iné zoznamy|Databázy a servis|O nás
Slovakia SUKL · SlovakiaWHO observes World Patient Safety Day on 17 September; this year focuses on patient safety in chronic non-communicable diseases.
Slovakia SUKL · SlovakiaWHO World Patient Safety Day on 17 September focuses this year on patient safety in chronic non-communicable diseases.
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 · SlovakiaNáučná relácia, ktorú štátny ústav pripravuje v spolupráci s TV Doktor od roku 2025 27.08.2026| Článok|ŠÚKL v médiách|Médiá|Pre verejnosť, pacientov a médiá
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 · SlovakiaPrehľad liekov s obsahom pseudoefedrinu viazané na lekársky predpis. 19.08.2026| Nezaradené|Registrované lieky s obsahom drogového prekurzora|Drogové prekurzory|Pre odborníkov a firmy
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 · SlovakiaRegistrácia liekov a farmakovigilančná činnosť. Prebiehajúce zmeny v národnej legislatíve (zákon 362/2011).
Slovakia SUKL · SlovakiaStručné zhrnutie záverov zo zasadania Výboru pre hodnotenie rizík liekov (PRAC), ktoré sa uskutočnilo31.8.-3.9.2026. Plné znenie tlačovej správy sa nachádza na webovej stránke Európskej liekovej agentúry.
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 · SlovakiaŠtátny ústav pre kontrolu liečiv informuje, že dňa15. 9. 2026 bude podateľňa ŠÚKL zatvorená.V ostatných pracovných dňoch bude podateľňa otvorená v štandardných úradných hodinách.
Slovakia SUKL · SlovakiaSUKL experienced a technical error causing duplicate emergency notifications to be sent; duplicates should be ignored.
Slovakia SUKL · SlovakiaPlenvu and Moviprep withdrawn from distribution companies, pharmacies and healthcare facilities with urgent priority for specified batches.
Slovakia SUKL · SlovakiaOne batch (RD6172, expiry February 2029) of Tyverb 250 mg film-coated tablets withdrawn due to dissolution specification failure.
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 · 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 · SlovakiaRowatinex is being withdrawn from distribution companies, pharmacies and healthcare facilities with class II urgency.
Slovakia SUKL · Slovakia