Latest Articles
25. 01. 2021
Data Mailbox Set-up for Foreign Entities
The Ministry of Interior sets up data mailboxes upon request also for natural persons-entrepreneurs and legal entities-businesses incorporated in a foreign country.
13. 01. 2021
Requirements for Electronic Signature of Clinical Trial Applications Submitted In Fully Electronic Format
The electronic signature must meet the requirements of Regulation No 910/2014 on electronic identification and trust services for electronic transactions in the internal...
31. 12. 2020
List of reimbursed medicinal products valid as of 1.1.2021
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...
23. 12. 2020
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 December 2020
fully superseding opinions of 06 November 2020
30. 11. 2020
List of reimbursed medicinal products valid as of 1.12.2020
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...
13. 11. 2020
IMP with GMO for the treatment of COVID in CT 12.11.2020
Information on documentation to be submitted for clinical trials on medicinal products for the treatment of COVID-19, 7.11.2020, updated 12.11.2020
04. 11. 2020
Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure - Brexit and Christmas Break 2020/2021
The State Institute for Drug Control hereby informs the sponsors of clinical trials that VHP Christmas Break 2020 will be from 22 December 2020 to 6 January 2021.
23. 10. 2020
VHP procedures since 23rd October 2020
Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure
cz
