Published aricles: 22
List of reimbursed medicinal products valid as of 1.11.2013
Whole Article Thursday, 31. October 2013 | 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”).
Field Safety Corrective Actions in 2011
Whole Article Tuesday, 20. March 2012 | Author Veronika Petláková
Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).
Field Safety Corrective Actions in 2012
Whole Article Tuesday, 20. March 2012 | Author Veronika Petláková
Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).
Field Safety Corrective Actions in 2013
Whole Article Thursday, 3. January 2013 | Author Veronika Petláková
Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).
Obligations of sponsors of clinical investigations
Whole Article Tuesday, 30. June 2015 | Author Petra Horáková
Application for authorisation of clinical investigation conduct
Whole Article Tuesday, 30. June 2015 | Author Petra Horáková
Important information for Applicants for Clinical Trials
Whole Article Tuesday, 15. October 2013 | Author MUDr. Tomáš Boráň
State Institute for Drug Control notifies to Applicants for Clinical Trials that will not temporarily participate in the assessment of applications under the Voluntary Harmonisation Procedure (VHP).
Payments for variations submitted before the effective date of the reimbursement decree (effective as of 15 October 2013)
Whole Article Monday, 7. October 2013 | Author Petra Špimrová
The State Institute for Drug Control hereby informs of the rules of reimbursement of costs of marketing authorisation variations applied for before the effective date of the amended Decree No. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”), i.e. until 14 October 2013.
Amendment to the reimbursement decree – payments for marketing authorisation variations effective as of 15 October 2013
Whole Article Friday, 11. October 2013 | Author Petra Špimrová
On 15 October 2013, the amendment to decree no. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”), has come into effect.
Payments for marketing authorisation variations
Whole Article Thursday, 25. July 2013 | Author Lucie Šustková
UST-37
Whole Article Tuesday, 27. August 2013 | Author
APPLICATION FOR A HOSPITAL EXEMPTION FOR ADVANCED THERAPY MEDICINAL PRODUCTS
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