Latest Articles

13. 05. 2020

HOME CARE

Conditions under which it will be possible to include “ Home Care ” into the conduct of clinical trials also outside the period of COVID-19 pandemics.

 

12. 05. 2020

Brexit – on 7 May 2020, the European Commission published an updated notice to stakeholders

„WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF CLINICAL TRIALS“ 

 

05. 05. 2020

SÚKL is involved in Simultaneous National Scientific Advice (SNSA) Pilot Project

EU-Innovation Network, who`s member is also State Institute for Drug Control (SÚKL), announced launch of Simultaneous National Scientific Advice (SNSA) Pilot Project. SÚKL...

 

30. 04. 2020

List of reimbursed medicinal products valid as of 1.5.2020

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 of...

 

16. 04. 2020

VHP - Voluntary Harmonization Procedures – re-engaging in VHP

SUKL will participate again fully in VHP from 20 April 2020.

 

06. 04. 2020

Update of requirements for Marketing Authorisation Holders to Evaluate the Risk of the Presence of Nitrosamines

In compliance with the procedure outlined under Art. 5(3) of Regulation (EC) no. 726/2004, holders of marketing authorisations of human medicinal products containing...

 

31. 03. 2020

List of reimbursed medicinal products valid as of 1.4.2020

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...