Latest Articles

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...

 

24. 09. 2021

Q&A for labelling

The requirements for labelling of Investigational medicinal products are given in European Commission guideline: The Rules Governing Medicinal Products in the European...