Latest Articles
26. 01. 2022
KLH-CTIS-01
Version 1 of 20 January 2022 The Guideline stipulates the requirements governing documents to be submitted with Part II of application for clinical trial...
31. 12. 2021
List of reimbursed medicinal products valid as of 1.1.2022
Státní ústav pro kontrolu léčiv v souladu s § 39n odst. 1 zákona č. 48/1997 Sb. o veřejném zdravotním pojištění v platném znění (dále jen "zákon") zveřejňuje Seznam cen a...
15. 12. 2021
Decree No 463/2021 on Detailed Conditions Governing the Conduct of Clinical Trials on Medicinal Products
Important notice for sponsors of clinical trials on medicinal products related to the coming into effect of Regulation No 536/2014.
10. 12. 2021
Applications for Revocation of Marketing Authorisations of Medicinal Products
SÚKL hereby informs marketing authorisation holders about the aspects of submitting applications for revocation of the medicinal product marketing authorisations, including...
30. 11. 2021
List of reimbursed medicinal products valid as of 1.12.2021
Acting in compliance with Section 39n(1) of Act No. 48/1997 Coll., on Public Health Insurance, as amended (“Act”), the State Institute for Drug Control publishes the List...
22. 11. 2021
Opinion of SÚKL's Department of Clinical Trials on Medicinal Products on Ongoing Clinical Trials and To-Be-Commenced Clinical Trials in Light of the COVID-19 Epidemiological Situation of 22 November 2021, added 25 November 2021
In view of the current serious and still worsening coronavirus epidemiological situation that can affect ongoing and newly initiated clinical trials, SÚKL hereby releases...
29. 10. 2021
List of reimbursed medicinal products valid as of 1.11.2021
Acting in compliance with Section 39n(1) of Act No. 48/1997 Coll., on Public Health Insurance, as amended (“Act”), the State Institute for Drug Control publishes the List...
30. 09. 2021
List of reimbursed medicinal products valid as of 1.10.2021
Acting in compliance with Section 39n(1) of Act No. 48/1997 Coll., on Public Health Insurance, as amended (“Act”), the State Institute for Drug Control publishes the List...
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