Latest Articles
24. 09. 2021
Q&A for labelling
The requirements for labelling of Investigational medicinal products are given in European Commission guideline: The Rules Governing Medicinal Products in the European...
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...
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.
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