Published aricles: 4
List of reimbursed medicinal products valid as of 1.1.2018
Whole Article Friday, 29. December 2017 | Author PharmDr. Kamil Kalousek
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 Prices and Reimbursements for Medicinal Products and Foods for Special Medicinal Purposes (“List”).
Amendments to protocol and updates to clinical trial dossier following the issuance of authorisation/approval of the conduct of the clinical trial
Whole Article Thursday, 14. December 2017 | Author
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.
GDPR – General Data Protection Regulation and clinical trials
Whole Article Friday, 8. December 2017 | Author
Notice to clinical trial sponsors that SÚKL shall not assess nor approve documents pertaining to personal data processing and protection
PHV-4 version 6
Whole Article Tuesday, 5. December 2017 | Author Lenka Jeglová
ELECTRONIC REPORTING OF ADVERSE DRUG REACTIONS