Latest Articles

31. 01. 2018

List of reimbursed medicinal products valid as of 1.2.2018

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...

 

04. 01. 2018

A New System of DCP Slots Allocation with SÚKL as the RMS

SÚKL informs about a new system of slots allocation within the scope of decentralised procedures (DCP) with SÚKL as the Reference Member State (RMS), effective as of 1...

 

03. 01. 2018

Information for sponsors of clinical trials/submitters of Development Safety Update Reports (DSURs)

Sponsors shall submit the DSUR for the investigational medicinal product on an annual basis. The DSUR shall reflect any newly available information obtained in the course of...

 

29. 12. 2017

List of reimbursed medicinal products valid as of 1.1.2018

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...

 

27. 12. 2017

Specification of requirements governing the submission of marketing authorisations in the form of duplicates

SÚKL hereby specifies the requirements governing marketing authorisation of duplicates and documentation to be submitted as part of applications for marketing authorisation...

 

14. 12. 2017

Amendments to protocol and updates to clinical trial dossier following the issuance of authorisation/approval of the conduct of the clinical trial

Clinical trial sponsors are kindly requested to send amendments to the protocol and updates to an approved/authorised clinical trial dossier in electronic format only.