Published aricles: 8
Whole Article Tuesday, 31. May 2022 | 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”).
Whole Article Monday, 30. May 2022 | Author
Annual Report of the SUKL activities in 2021.
Final Sale of Medicinal Products Following Approval of Variation to, Renewal and Transfer of Marketing Authorisation
Whole Article Friday, 10. December 2021 | Author Bc. Lucie Mrázková
With a view to frequent questions from marketing authorisation holders, SÚKL hereby provides more details on the final sale of medicinal products complying with the data and dossier valid prior to the implementation of a variation to marketing authorisation, prior to a marketing authorisation renewal or prior to the implementation of a marketing authorisation transfer. The information provided herein is applicable to medicinal products authorised via national procedures as well as MRP/DCP.
Whole Article Friday, 10. December 2021 | Author Petra Špimrová
With a view to frequent questions from marketing authorisation holders, SÚKL hereby provides more details on the implementation of variations to marketing authorisations, including the specifics of individual types of variations, as well as information regarding the implementation of marketing authorisation renewals and transfers. The information provided herein is applicable to medicinal products authorised via national procedures as well as MRP/DCP.
Whole Article Monday, 4. January 2021 | Author Veronika Petláková
Most Frequent Deficiencies in Submission of Applications for Marketing Authorisation of Medicinal Products
Whole Article Friday, 4. February 2022 | Author Bc. Lucie Mrázková
SÚKL hereby notifies applicants for marketing authorisation that the marketing authorisation application dossier should contain data concerning only the strengths and pharmaceutical forms of medicinal products that are the subject of the respective applications and, furthermore, notifies about other frequent validation mistakes of marketing authorisation applicants.