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 RepublicCzech Republic
Regulation
Category
Type
Date
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 RepublicSKP-1 version 4: Issuance of Good Clinical Practice certificates
Updated guidance on the issuance of Good Clinical Practice certificates by the Czech medicines authority.
Czechia SUKL · Czech RepublicDraft List of Prices and Reimbursements for Medicinal Products as of 20 September 2026
Updated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 September 2026.
Czechia SUKL · Czech RepublicDraft List of Prices and Reimbursement for Foods for Special Medical Purposes (FSMP) as of 10 September 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 RepublicCAU-05 version 8: Guidance for applications to change reimbursement amounts, conditions, and manufacturer maximum prices for medicinal products
Guidance document explaining how to complete applications for changes to reimbursement levels, conditions, and maximum manufacturer prices for medicines in Czechia.
Czechia SUKL · Czech RepublicCAU-04 version 10: Guidance for applications for reimbursement amount, conditions, and manufacturer maximum price of medicinal products
Guidance document on completing applications for pharmaceutical reimbursement, conditions of coverage, and manufacturer maximum pricing in Czechia.
Czechia SUKL · Czech RepublicList of prices and reimbursements for medicinal products effective 1 October 2026
Czech SUKL publishes the official list of prices and reimbursements for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicPharmacotherapeutic Information 10/2026: Relaxation of prescription requirements for general practitioners
Guidance on relaxed prescription requirements for general practitioners in Czech Republic.
Czechia SUKL · Czech RepublicNotice to pharmacy operators on use of online offerings from other pharmacies and transfers of medicinal products between pharmacies
SÚKL clarifies that medicinal products offered through pharmacy online mail-order services are not intended for supplying other pharmacies.
Czechia SUKL · Czech RepublicInformation on applications for certificates of pharmaceutical free sale
SÚKL published guidance on conditions and procedures for applying for free sale certificates for medicinal products.
Czechia SUKL · Czech RepublicMedicine withdrawal does not always mean patients must return the medicine
SUKL explains three levels of medicine recalls based on quality defects and patient risk; only patient-level recalls require return to pharmacy.
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 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 medicinal products effective 1 September 2026
Czech SUKL publishes the official list of prices and reimbursements for medicinal products under 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 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 RepublicPharmacotherapeutic Information 9/2026: Anticoagulation therapy strategy
Guidance on anticoagulation therapy strategy for healthcare professionals.
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 RepublicHow to check what your doctor prescribed on eRecipe and what the pharmacy dispensed
Radyprovsechny.cz | 19. 9. 2026 | Jak zjistit, co přesně vám lékař předepsal na eReceptu a co vám vydali v lékárně?
Czechia SUKL · Czech RepublicUpdate to web forms for applications on pharmaceutical reimbursement rates and conditions
SUKL updated web submission forms for pharmaceutical reimbursement applications to include a section on joint clinical health technology assessment under EU HTA Regulation 2021/2282.
Czechia SUKL · Czech RepublicFree Sales Certificate applications via ISZP only from 1 September 2026
From 1 September 2026, Free Sales Certificate applications must be submitted exclusively through ISZP (Medical Device Information System), not RZPRO (Medical Device Register).
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. 16 – Medical Devices Control Department: Medical devices in daily healthcare facility practice
TÉMA: Zdravotnické prostředky v každodenní praxi zdravotnického zařízení | Datum konání: 3. 11. 2026 9:00–15:00 | prezenčně – opakování semináře z roku 2026, který je určený poskytovatelům bez předchozí účasti na obdo...
Czechia SUKL · Czech RepublicSeminar No. 15 – Medical Devices Control Department: Obligations of distributors and importers of medical devices
TÉMA: Povinnosti distributorů a dovozců zdravotnických prostředků | OPAKOVÁNÍ semináře z 22. 1. 2026 | Datum konání: 8. 10. 2026 9:00–12:30 | prezenčně
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 bez předchozí účasti na obdob...
Czechia SUKL · Czech RepublicSÚKL establishes Advisory Body for Patients and Consumers
Czech medicines agency SÚKL established an advisory body to strengthen collaboration with patient and consumer organisations on medicines, devices and tissue products.
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 RepublicPatients as partners in safe treatment
SUKL organised meetings with patients and patient organisations on World Patient Safety Day (17 September) to raise awareness of safe healthcare and shared responsibility.
Czechia SUKL · Czech RepublicSpecific Therapeutic Programme – Levomepromazine for intramuscular/intravenous administration
Call for proposals for a specific therapeutic programme for levomepromazine injectable solution for intravenous or intramuscular administration.
Czechia SUKL · Czech RepublicList of medicines not reimbursed from health insurance as of 1 October 2026
Register of authorised medicinal products not covered by health insurance with active market presence in March–August 2026.
Czechia SUKL · Czech RepublicList of prices and reimbursements for foods for special medical purposes, effective 1 October 2026
Státní ústav pro kontrolu léčiv v souladu s ustanovením § 39zb odst. 1 zákona č. 48/1997 Sb. o veřejném zdravotním pojištění a o změně a doplnění některých souvisejících zákonů (dále jen „zákon“) zveřejňuje Seznam cen...
Czechia SUKL · Czech RepublicNAPO becomes member of new SÚKL advisory body for patients and consumers (POPS)
Silapacientu.cz | 22. 9. 2026
Czechia SUKL · Czech RepublicCall for proposals: Specific therapeutic programme for lorazepam for intramuscular/intravenous administration
Czech SUKL invites proposals for a specific therapeutic programme for lorazepam intramuscular/intravenous formulations.
Czechia SUKL · Czech RepublicSeminar No. 20 – Seminar for Pharmacists – Current Topics
TÉMA: Seminář č. 20 - Seminář pro lékárníky – aktuální témata | Datum konání: 4. 11. 2026 10:00–14:30 | prezenčně a on-line
Czechia SUKL · Czech RepublicInformation request dated 25 May 2026
Ústav obdržel žádost týkající se zdravotnických prostředků hrazených z veřejného zdravotního pojištění.
Czechia SUKL · Czech RepublicSeminar No. 21 – Good Distribution Practice Seminar
TÉMA: Seminář správné distribuční praxe | Datum konání: 26. 11. 2026 10:00 – 14:30 | prezenčně a on-line
Czechia SUKL · Czech RepublicConference invitation: Treatment safety in daily practice – Pharmacovigilance in healthcare workers
SUKL and AIFP experts are hosting a conference for healthcare workers on medication safety and pharmacovigilance.
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 RepublicFlu vaccination: first vaccine doses have arrived in the Czech Republic
Over 500,000 doses of flu vaccines have been delivered to the Czech Republic for the 2024 vaccination season, including standard and high-dose formulations for seniors.
Czechia SUKL · Czech RepublicSeminar No. 19 – New legislation in medicine availability
TÉMA: Nová legislativa v dostupnosti LP | Datum konání: 1. 12. 2026 9:00–15:00 | prezenčně a on-line
Czechia SUKL · Czech Republic
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