Latest Articles
14. 05. 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 14 May 2020
superseding opinions of 23 April 2020
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...
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