State Institute for Drug Control

31. 08. 2021

List of reimbursed medicinal products valid as of 1.9.2021

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...

27. 08. 2021

Pharmacovigilance activities within a specific therapeutic programme

State Institute for Drug Control (hereinafter “Institute”) publishes a list of pharmacovigilance activities for applicants for specific therapeutic programmes.

30. 06. 2021

List of reimbursed medicinal products valid as of 1.7.2021

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...

11. 06. 2021

Opinion of SÚKL´s Department of Clinical Trials of Medicinal Products from the 22 December 2020 will expire on the 30 June 2021

10. 06. 2021

Information for marketing authorisation holders concerning the declaration of general classification for supply on medicinal product labelling

SÚKL hereby informs marketing authorisation holders on possible ways of showing the general classification for supply on medicinal product labelling.

10. 06. 2021

Information for marketing authorisation holders concerning ways of introducing blue-box information on medicinal product labelling

SÚKL hereby informs marketing authorisation holders about an update to the guidance laying down blue-box requirements for medicinal product labelling.

02. 06. 2021

Important information for clinical trial applicants concerning the coming into force of Regulation No 536/2014 and the possibilities of its practical application

31. 05. 2021

List of reimbursed medicinal products valid as of 1.6.2021

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...