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 · SlovakiaInformation on influenza vaccines available in Slovakia for the 2026/2027 season, with guidance on adverse event reporting to SUKL.
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 · SlovakiaLegislative change effective 1 January 2025 regarding post-registration processes and conditions of marketing authorisations for human medicines.
Slovakia SUKL · SlovakiaPharmeuropa 38.3 is open for comment until 30 September 2026.
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 · SlovakiaInstructions for completing the adverse event report form TL SV OF 007 for suspected adverse events associated with vaccination.
Slovakia SUKL · Slovakia20.08.2026| Článok|Zmeny podmienok povolení na uvedenie liekov 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 · Slovakia20.08.2026| Článok|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 · SlovakiaThe European Pharmacopoeia sets technical requirements for preparation, manufacture, labelling, storage and quality assessment of medicinal products and excipients.
Slovakia SUKL · SlovakiaThe third updated edition of the Slovak Pharmaceutical Codex entered into force on 15 July 2026.
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 · SlovakiaBasic information on drug and preparation categories, their characteristics, registration requirements and market authorisation procedures.
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 · 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 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 on the 180-day transition period for marketing packs under the original marketing authorisation holder's name following registration transfer.
Slovakia SUKL · SlovakiaGuidance on revocation, notification, and requirements for powers of attorney in pharmaceutical regulatory proceedings.
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 · Slovakia09.09.2026| Oznam|Aktuálne informácie|Zdravotnícke pomôcky|Pre odborníkov a firmy
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 · 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 · 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 · 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 · SlovakiaOne batch (RD6172, expiry February 2029) of Tyverb 250 mg film-coated tablets withdrawn due to dissolution specification failure.
Slovakia SUKL · SlovakiaPlenvu and Moviprep withdrawn from distribution companies, pharmacies and healthcare facilities with urgent priority for specified batches.
Slovakia SUKL · Slovakia