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Published aricles: 8


List of reimbursed medicinal products valid as of 1.6.2022

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”).  


Annual Report 2021

Annual Report of the SUKL activities in 2021.  


Final Sale of Medicinal Products Following Approval of Variation to, Renewal and Transfer of Marketing Authorisation

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.    


Implementation of Variations to, Renewals and Transfers of Marketing Authorisations

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.  


REG-94 version 2


Guidelines and forms for Specific Therapeutic Programmes


UST-20 version 1


Most Frequent Deficiencies in Submission of Applications for Marketing Authorisation of Medicinal Products

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.