Published aricles: 5
List of reimbursed medicinal products valid as of 1.3.2023
Whole Article Tuesday, 28. February 2023 | 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”).
Final Sale of Medicinal Products Following Approval of Variation to, Renewal and Transfer of Marketing Authorisation
Whole Article Monday, 20. February 2023 | Author Bc. Lucie Mrázková
Implementation of Variations to, Renewals and Transfers of Marketing Authorisations
Whole Article Monday, 20. February 2023 | Author Bc. Lucie Mrázková
Applications for Transfers of Marketing Authorisations of Medicinal Products
Whole Article Thursday, 25. August 2022 | Author Bc. Lucie Mrázková
SÚKL informs marketing authorisation holders about the aspects of submitting applications for transfers of the medicinal product marketing authorisations, including information on differences between marketing authorisation transfers effective as of the date when the decisions on the marketing authorisation transfers come into force or as of a future date. The provided information applies to medicinal products authorised via national procedures as well as MRP/DCP.
Applications for Changes of the Labelling or PIL Not Associated with SmPC (Type P Variations)
Whole Article Monday, 29. August 2022 | Author Bc. Lucie Mrázková
SÚKL informs marketing authorisation holders (MAH) about the aspects of submitting applications for changes of the labelling or PIL not associated with the SmPC (Notification under Article 61(3) of Directive 2001/83/EC and under Section 35(5) of the Act on Pharmaceuticals; so called Type P variations), incl. procedural differences between national and MRP variations and how to distinguish between them in specific cases.