HMA/EMA Multi-stakeholder Forum on Artificial Intelligence
HMA and EMA convene a multi-stakeholder forum on AI and data to build trustworthy AI on solid data foundations.
Slovenia JAZMP · SloveniaSlovenia
Regulation
Category
Type
Date
Obligation to implement special quality control – veterinary medicinal products
Slovenia's food and veterinary authority imposed special quality control requirements for veterinary medicinal products on 10 July 2026.
Slovenia JAZMP · SloveniaJAZMP: External email reception issue resolved
Technical issue with external email reception at JAZMP was resolved on 9 October around 11:00.
Slovenia JAZMP · SloveniaProfessional recommendation for transition from Kreon 25,000 to Panzynorm forte in adult patients
JAZMP publishes professional guidance on switching adult patients from Kreon 25,000 to Panzynorm forte.
Slovenia JAZMP · SloveniaAnnouncement: #MedSafetyWeek 2026 campaign – call for participation
International campaign 2–8 November 2026 to raise awareness of adverse drug reaction reporting.
Slovenia JAZMP · SloveniaUpdated GTIN list published
JAZMP publishes updated list of national medicine identifiers and product codes submitted by stakeholders for regulatory implementation.
Slovenia JAZMP · SloveniaParenteral iron medicines: safety review initiated
PRAC committee has initiated a safety review of parenteral iron medicines to assess the risk of low blood phosphate levels and associated bone complications.
Slovenia JAZMP · SloveniaCall to pharmaceutical wholesalers for supply of medicines
JAZMP calls wholesalers to temporarily import cinacalcet 30 mg film-coated tablets from other EU member states due to supply disruption.
Slovenia JAZMP · SloveniaHighlights from the PRAC Committee meeting
Odbor za varnost zdravil (PRAC) pri Evropski agenciji za zdravila (EMA) je v objavi s seje, ki je potekala od 31. avgusta do 3. septembra, izpostavil naslednje: Začetek pregleda varnosti […]
Slovenia JAZMP · SloveniaJAZMP telephone service disruption notice
Telephone access to JAZMP may experience intermittent disruptions over the next two days due to technical maintenance work.
Slovenia JAZMP · SloveniaInternal Medicine Specialty Recommendations for Priority Classification of Adult Patients in Prescribing Kreon
JAZMP publishes specialty guidance on patient prioritization criteria for prescribing pancreatic enzyme replacement therapy Kreon.
Slovenia JAZMP · SloveniaNinth issue of the Pharmacovigilance Bulletin published
The ninth issue of the Pharmacovigilance Bulletin is now available, featuring routine notices and reporting on adverse drug effects in 2025.
Slovenia JAZMP · SloveniaSeventh Edition of Formularium Slovenicum (FS 7.0) to be published
Slovenia's medicines agency announces publication of the seventh edition of the national pharmaceutical formulary on 28 August 2026.
Slovenia JAZMP · SloveniaNotice of Ministry of Health Supervision over the Work of the Public Agency of the Republic of Slovenia for Medicines and Medical Devices (JAZMP)
Zainteresirano javnost obveščamo, da je Ministrstvo za zdravje (v nadaljevanju: MZ) na podlagi četrtega odstavka 180. člena Zakona o zdravilih (Uradni list RS, št. 17/14, 66/19, 102/24 – ZZKZ, 24/25, […]
Slovenia JAZMP · SloveniaMedicines containing desogestrel or etonogestrel: direct healthcare professional communication on meningioma risk
Direct healthcare professional communication issued on meningioma risk associated with medicines containing desogestrel or etonogestrel.
Slovenia JAZMP · SloveniaCall to pharmaceutical wholesalers for supply of medicines
JAZMP invites wholesalers to temporarily import mefloquine 250 mg tablets and other medicines from other EU member states to address supply shortages.
Slovenia JAZMP · SloveniaHighlights from PRAC Committee Meeting
Odbor za varnost zdravil (PRAC) pri Evropski agenciji za zdravila (EMA) je v objavi s seje, ki je potekala od 6. do 9. julija, izpostavil naslednje: Nove informacije za zdravstvene […]
Slovenia JAZMP · SloveniaSafety Corrective Action Notice: IALUADAPTER® / UroDapter® Medical Devices and IALURIL Prefill System
Slovene medicines and medical devices agency issues safety corrective action for IALUADAPTER/UroDapter devices and IALURIL Prefill system issued by Pharmico Medical.
Slovenia JAZMP · SloveniaOpinion and recommendations of internal medicine specialty on shortage of oral medicines containing isosorbide mononitrate (ISMN)
JAZMP publishes specialist guidance on clinical management during shortage of isosorbide mononitrate oral medicines.
Slovenia JAZMP · SloveniaSafety Alerts for Medical Devices – August 2026
JAZMP publishes safety corrective action notices for medical devices received from manufacturers or authorised representatives.
Slovenia JAZMP · SloveniaSafety Alerts for Medical Devices – July 2026
JAZMP publishes safety corrective action notices for medical devices received from manufacturers or authorised representatives.
Slovenia JAZMP · SloveniaOcrevus (ocrelizumab): Direct Healthcare Professional Communication on new hepatic safety risk
Direct Healthcare Professional Communication issued regarding a new hepatic safety risk associated with Ocrevus (ocrelizumab).
Slovenia JAZMP · SloveniaSafety Alerts for Medical Devices – June 2026
JAZMP publishes safety corrective action notices for medical devices received from manufacturers or authorised representatives.
Slovenia JAZMP · SloveniaAmoxiclav powder for oral suspension – new formulation and changed preparation instructions
Updated information on Amoxiclav 400 mg/57 mg per 5 ml powder for oral suspension regarding new formulation and suspension preparation method.
Slovenia JAZMP · SloveniaRybelsus (semaglutide): risk of medication errors with new formulation
Risk of medication errors identified with new Rybelsus formulation launching in Slovenia in early September.
Slovenia JAZMP · SloveniaLitfulo (ritlecitinib): Direct Healthcare Professional Communication on cardiovascular risk mitigation
Direct healthcare professional communication issued with updated recommendations to reduce risk of serious cardiovascular adverse events.
Slovenia JAZMP · SloveniaRybelsus (oral semaglutide): Direct Healthcare Professional Communication on medication error risk
Direct Healthcare Professional Communication issued regarding risk of medication errors due to introduction of new formulation of Rybelsus.
Slovenia JAZMP · SloveniaPublic notice regarding samples stored by Biobanka d.o.o.
JAZMP clarifies it did not order destruction of samples held by Biobanka d.o.o., responding to parental inquiries.
Slovenia JAZMP · SloveniaNotice of destruction of samples held by Biobanke d.o.o.
All samples not transferred to other storage providers or donated for research purposes were destroyed due to temperature rise.
Slovenia JAZMP · Slovenia
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