MDCG Opinion 2026-5 on UDI assignment between manufacturers and distributors
Publication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech Republic
Jurisdiction
Czech Republic
Regulation
Category
Type · Breadth
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Handling of medical devices intended for direct patient payment, not from public health insurance funds – Information update 8 June 2026
Guidance on handling medical devices in outpatient care settings when paid directly by patients rather than through public health insurance.
Czechia SUKL · Czech RepublicDraft List of Prices and Reimbursements for Medicinal Products as of 20 August 2026
Updated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 August 2026.
Czechia SUKL · Czech RepublicUST-45 version 3: Notification of initiation, suspension, resumption and termination of medicinal product marketing – supply disruption reporting and MAH stock obligations
Guidance on reporting requirements for marketing authorisation holders regarding initiation, suspension, resumption and termination of medicinal product distribution, including supply disruption notification and inventory obligations.
Czechia SUKL · Czech RepublicDraft List of Prices and Reimbursement for Foods for Special Medical Purposes as of 10 August 2026
List establishes reimbursement prices, maximum manufacturer prices, and reimbursement conditions for categorised and non-categorised foods for special medical purposes covered by public health insurance.
Czechia SUKL · Czech RepublicCorrection to the List of Prices and Reimbursements for Medicinal Products effective 1 August 2026
SUKL publishes a corrected list of prices and reimbursements for medicinal products under the public health insurance law.
Czechia SUKL · Czech RepublicList of prices and reimbursements for medicinal products effective 1 August 2026
Czech SUKL publishes the official list of prices and reimbursement rates for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicSpecial therapeutic programme – tamoxifen
List of unregistered medicinal products from which individualised preparations may be made under a special therapeutic programme.
Czechia SUKL · Czech RepublicDraft List of Prices and Reimbursements for Medicinal Products as of 20 July 2026
Updated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 July 2026.
Czechia SUKL · Czech RepublicDraft List of Prices and Reimbursement for Foods for Special Medical Purposes as of 10 July 2026
List establishes reimbursement prices, maximum manufacturer prices, and reimbursement conditions for categorised and non-categorised foods for special medical purposes from public health insurance.
Czechia SUKL · Czech RepublicList of prices and reimbursements for foods for special medical purposes, effective 1 August 2026
Czech SUKL publishes the official price and reimbursement list for foods for special medical purposes under public health insurance.
Czechia SUKL · Czech RepublicChange in procedure for submitting Free Sale Certificate (FSC) applications
From 10 August 2026, Free Sale Certificate applications will be submitted through the Medical Devices Information System (ISZP).
Czechia SUKL · Czech RepublicCzech patients can now collect medicines prescribed on Czech e-Prescription in Austrian pharmacies
From 5 August 2026, Czech e-Prescriptions can be redeemed in Austrian pharmacies, expanding cross-border electronic prescribing interoperability.
Czechia SUKL · Czech RepublicSeminar No. 14 – Medical Devices Control Department: 3D printing in hospital environments
TÉMA: 3D tisk v prostředí nemocnic – workshop pořádaný ve spolupráci SÚKL a České společnosti pro 3D tisk v medicíně | Datum konání: 12. 11. 2026 9:00–15:00 | prezenčně
Czechia SUKL · Czech RepublicSeminar No. 13 – Medical Devices Control Department: Medical devices in daily practice of healthcare facilities
TÉMA: Zdravotnické prostředky v každodenní praxi zdravotnického zařízení | Datum konání: 8. 9. 2026 9:00–15:00 | prezenčně – opakování semináře z roku 2026, který je určený poskytovatelům <b style="color: #F...
Czechia SUKL · Czech RepublicInformation request dated 25 May 2026
Ústav obdržel žádost týkající se zdravotnických prostředků hrazených z veřejného zdravotního pojištění.
Czechia SUKL · Czech RepublicCzech Ministry of Health presents first National Strategy for Clinical Trials and planned information portal for patients and professionals
Czech Ministry of Health adopted the first National Strategy for Clinical Trials of Human Medicinal Products 2035, aiming to improve research conditions and patient access to innovative therapies.
Czechia SUKL · Czech RepublicTamoxifen: exceptional individual preparation from unregistered medicinal products within a special treatment programme
Czech Ministry of Health established conditions for a special treatment programme permitting temporary individual preparation of tamoxifen 10 mg and 20 mg from selected unregistered medicinal products registered in other EU/EEA member states.
Czechia SUKL · Czech RepublicRestriction on prescribing and dispensing of tamoxifen medicinal products
Tamoxifen may be prescribed and dispensed only in single-pack quantities per prescription, with refills permitted no sooner than 21 calendar days after the last prescription.
Czechia SUKL · Czech RepublicSpecific Therapeutic Programme – hexoprenaline sulphate
Call for proposals for a specific therapeutic programme for hexoprenaline sulphate medicinal products in intravenous form.
Czechia SUKL · Czech RepublicQuestions and answers on tamoxifen availability
Frequently asked questions addressing the current supply situation for tamoxifen.
Czechia SUKL · Czech RepublicSpecific Therapeutic Programme – Quetiapine, Extended-Release Tablets
Call for proposals for a specific therapeutic programme for quetiapine extended-release tablet formulations.
Czechia SUKL · Czech RepublicMeeting with ČAFF representatives, 15 June 2026
Záznam z jednání SÚKL - ČAFF ze dne 15. 6. 2026
Czechia SUKL · Czech RepublicUST-46 version 2: Report of medicinal product market supply (REG-13)
Hlášení dodávek léčivých přípravků na trh (REG-13)
Czechia SUKL · Czech RepublicList of medicines not reimbursed from health insurance as of 1 August 2026
Register of authorised medicinal products not covered by health insurance with active market presence in January–June 2026.
Czechia SUKL · Czech RepublicHealthcare Professional Communication: Desogestrel and etonogestrel – meningoma risk and risk minimisation measures
Direct healthcare professional communication on meningoma risk associated with desogestrel and etonogestrel-containing medicinal products and measures to minimise this risk.
Czechia SUKL · Czech RepublicNearly 6,000 packs of tamoxifen heading to pharmacies; further supplies en route
Czech health ministry and SUKL secured nearly 6,000 packs of tamoxifen to address supply shortage; additional shipments arriving next week.
Czechia SUKL · Czech RepublicSpecial therapeutic programme to increase tamoxifen availability; supply negotiations ongoing for additional thousands of packs
Czech health ministry established special therapeutic programme allowing pharmacies to repackage tamoxifen from intact blisters to address supply shortages and extend available stock.
Czechia SUKL · Czech RepublicTamoxifen supply situation stabilising; over 10,000 packs arriving in Czechia
Tamoxifen availability in Czech Republic improving significantly; over 10,000 packs arriving in coming days with further supplies secured for autumn.
Czechia SUKL · Czech RepublicInformation on the availability of tamoxifen
SUKL provides information on ensuring availability of tamoxifen medicinal products and measures taken.
Czechia SUKL · Czech RepublicEnsuring medicines for breast cancer patients
Studio 24, Česká televize | 2. 8. 2026 | Chybějící lék pro pacientky s rakovinou prsu
Czechia SUKL · Czech RepublicNew treatment option for neovascular (wet) age-related macular degeneration
EMA recommended marketing authorisation for Susvimo (ranibizumab) in the European Union.
Czechia SUKL · Czech RepublicFirst oral treatment for plaque psoriasis based on interleukin-23 receptor antagonist
EMA recommended granting marketing authorisation for Icotyde (icotrokinra) in the European Union.
Czechia SUKL · Czech RepublicAlert: Counterfeit medicinal product Mounjaro detected
SÚKL warns of the detection of counterfeit Mounjaro medicinal product in circulation.
Czechia SUKL · Czech RepublicInformation Letter – Litfulo (ritlecitinib tosylate)
Updated risk minimisation recommendations for serious cardiovascular events, malignancy, venous thromboembolism, serious infections and death.
Czechia SUKL · Czech RepublicAlert: Counterfeit medicinal product Nebido detected
SÚKL warns of detection of counterfeit Nebido 250mg/ml in circulation.
Czechia SUKL · Czech RepublicAlert: Suspected counterfeit medicinal product Keytruda 100 mg/vial
SÚKL alerts to suspected counterfeit Keytruda 100 mg/vial in circulation.
Czechia SUKL · Czech RepublicAlert: Counterfeit Mounjaro medicinal product detected
SÚKL warns of the detection of counterfeit Mounjaro medicinal product in circulation.
Czechia SUKL · Czech RepublicRowatinex – withdrawal from healthcare facilities level
SÚKL announces withdrawal of specified batches of Rowatinex oral drops 1×10 ml from healthcare facilities.
Czechia SUKL · Czech RepublicBuprenorphine Stada – supply disruption
Supply disruption notice for four buprenorphine transdermal patch strengths (5, 10, 20, 30 mcg/h).
Czechia SUKL · Czech RepublicChange of registration for medicinal product ROWATINEX, oral drops, solution
SÚKL informs healthcare professionals and patients of a change to the shelf life of ROWATINEX oral drops solution.
Czechia SUKL · Czech RepublicStrength expression amendment for medicinal product CAMPRAL 300 mg enterosolvent tablets
SUKL informs healthcare professionals and patients of a strength expression amendment for CAMPRAL 300 mg enterosolvent tablets.
Czechia SUKL · Czech RepublicInformation Letter: Tavneos (avakopan) – Recommendation for Withdrawal of EU Marketing Authorisation and Strengthened Hepatic Monitoring Requirements
Healthcare professional communication recommending withdrawal of Tavneos (avakopan) marketing authorisation in the EU and tightened liver function monitoring requirements.
Czechia SUKL · Czech RepublicInformation Letter – Paricalcitol Fresenius
Upozornění držitele rozhodnutí o registraci léčivého přípravku Paricalcitol Fresenius, 5mcg/ml inj. sol. 5x1ml.
Czechia SUKL · Czech RepublicInformation letter – Vyvgart 1000mg injection solution
Upozornění držitele rozhodnutí o registraci léčivého přípravku Vyvgart, 1000mg inj. sol. 1x5,6ml
Czechia SUKL · Czech RepublicLibtayo – withdrawal from healthcare facilities level
SÚKL announces withdrawal of a batch of Libtayo 350mg infusion concentrate solution 1×7ml from healthcare facilities.
Czechia SUKL · Czech RepublicHealthcare Professional Communication – Ixchiq: Indication restriction to high-risk chikungunya disease patients
Indication for Ixchiq restricted to persons at high risk of chikungunya disease.
Czechia SUKL · Czech RepublicInformation request dated 8 June 2026
Ústav obdržel žádost o poskytnutí rozhodnutí Ústavu vydaného pod sp. zn. sukls48819/2023
Czechia SUKL · Czech RepublicInformation request dated 19 May 2026
Ústav obdržel žádost týkající se dovozu neregistrovaných léčivých přípravků.
Czechia SUKL · Czech RepublicInformation Letter – Tolucombi
Safety alert concerning Tolucombi (telmisartan/hydrochlorothiazide) tablets in three strengths and pack sizes.
Czechia SUKL · Czech Republic
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