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Published aricles: 40


List of reimbursed medicinal products valid as of 1.8.2013

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”).  


SUKL Bulletin 6/2013

SUKL Bulletin 6/2013 was published 21. 6. 2013  


SUKL Bulletin 7/2013

SUKL Bulletin 7/2013 was published 25. 7. 2013  


Annual Report 2011

Annual Report of the SUKL activities in 2011  


Annual Report 2012

Annual Report of the SUKL activities in 2012  


REG-90

Application for change to the labelling or package leaflet not connected with the summary of product characteristics.  


Information about requirement of submission of Clinical Study Reports

Current information for sponsors, contact persons, CRO, about the requirement to submit the Clinical Study Report to State Institute for Drug Control (hereinafter „Institute“).  


List of reimbursed medicinal products valid as of 1.7.2013

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”).  


List of reimbursed medicinal products valid as of 1.6.2013

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”).  


List of reimbursed medicinal products valid as of 1.5.2013

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”).  


Adverse Drug Reaction (ADR) reporting


PSUR – Periodic Safety Update Reports


PASS – Post-Authorisation Safety Studies


RMP – Risk Management Plan


GVP – Good Pharmacovigilance Practices


Marketing authorisation variations


Sunset clause


General question


Questions and answers on the amended Act on Pharmaceuticals - marketing authorisations

The amended Act on Pharmaceuticals came into effect on 2 April 2013. We would like to summarize the major changes concerning marketing authorisations, pharmacovigilance and clinical trials, in the form of questions and answers.  


Questions and answers on the amended Act on Pharmaceuticals - pharmacovigilance

The amended Act on Pharmaceuticals came into effect on 2 April 2013. We would like to summarize the major changes concerning marketing authorisations, pharmacovigilance and clinical trials, in the form of questions and answers.  


Use of unauthorised Advanced Therapy Medicinal Products

Pursuant to Section 8 (3) (b) (2)  


Use of non-authorised medicinal products


Questions and answers on the amended Act on Pharmaceuticals - clinical trials

The amended Act on Pharmaceuticals came into effect on 2 April 2013. We would like to summarize the major changes concerning marketing authorisations, pharmacovigilance and clinical trials, in the form of questions and answers.