Published aricles: 58
Questions regarding specific therapeutic programmes
Whole Article Friday, 4. June 2010 | Author MUDr. Tomáš Boráň
Questions and answers.
Have you seen any cases when the tested substances were given to patients without the patients being aware of it?
Whole Article Monday, 28. February 2011 | Author Lucie Šustková
What is the actual mechanism of action of monoclonal antibodies? Do they stimulate the immune system or do they act as a means which transports the pharmaceutical to the affected tissue?
Whole Article Monday, 28. February 2011 | Author Lucie Šustková
TGN1412 belongs to the group of monoclonal antibodies. Are any medicines using monoclonal antibodies being tested in the Czech Republic?
Whole Article Monday, 28. February 2011 | Author Lucie Šustková
Can something similar happen in the Czech Republic?
Whole Article Monday, 28. February 2011 | Author Lucie Šustková
What are the possible causes of such a severe adverse reaction of the organism of the volunteers in the case of TGN1412?
Whole Article Monday, 28. February 2011 | Author Lucie Šustková
Is the new medicine for arthritis, leukaemia and multiple sclerosis called TGN1412, which was life-threatening for volunteers on whom the product was tested in the UK, available in the Czech Republic?
Whole Article Monday, 28. February 2011 | Author Lucie Šustková
Questions on clinical trials on human pharmaceuticals
Whole Article Friday, 20. August 2010 | Author MUDr. Tomáš Boráň
Questions and answers from workshops for pharmacies held on April 8 and April 16 2010
Should adverse reactions, if applicable, be reported with the use of non-authorised medicinal products? If so, how should they be reported and to whom, and who will be responsible for the reporting?
Whole Article Friday, 25. February 2011 | Author Lucie Šustková
Can a healthcare facility be specifically penalised for failure to report the use of a non-authorised medicinal product to SÚKL?
Whole Article Friday, 25. February 2011 | Author Lucie Šustková
Questions on individual use of a non-authorised pharmaceutical
Whole Article Friday, 4. June 2010 | Author Veronika Petláková
List of reimbursed medicinal products - periodical update
Whole Article Tuesday, 22. February 2011 | Author
Periodical update included medicinal products which come to power in the end of January.
List of reimbursed medicinal products valid as of 1.2.2011
Whole Article Tuesday, 22. February 2011 | Author
Updated List of medicinal products and foods for special medical purposes with reimbursement from the public health insurance.
Haemovigilance
Whole Article Wednesday, 19. May 2010 | Author Veronika Petláková
Haemovigilance shall mean a set of systematic procedures for supervision over transfusion products and raw materials from blood and its components for further manufacture, in terms of serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological monitoring of donors (Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts).
Payment of administrative fees
Whole Article Tuesday, 28. December 2010 | Author Veronika Petláková
With regard to the provision of Act No 634/2004 Coll., on Administrative fees, as amended, an applicant is obliged to pay administrative fees for the submission of an application.
Interactive form for application related to covering expenditures
Whole Article Wednesday, 16. February 2011 | Author Veronika Petláková
Information on progress of administrative procedures
Whole Article Tuesday, 28. December 2010 | Author Veronika Petláková
List of administrative procedures concerning the determination of the maximum price and the amount and conditions of reimbursement of medicinal products and foods for special medical purposes - only in czech .
Payment of costs for expert activities conducted upon request
Whole Article Tuesday, 28. December 2010 | Author Veronika Petláková
The conditions and payment process for the reimbursement of costs for expert activities conducted upon request (Section 112 of Act No 378/2007 Coll., on Pharmaceuticals, as amended, and Section 27 of Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man and on Amendments to Related Acts, and Section 94 of Act No 268/2014 Coll., on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees, as Amended) are stipulated in SÚKL guidelines UST-29 and UST-36. The currently effective versions of guidelines UST-29 and UST-36 specify the conditions and procedures applicable to the payment process for the reimbursement of costs for expert activities conducted upon request.
Waivers and refunds of reimbursements of costs for expert activities conducted upon request
Whole Article Tuesday, 28. December 2010 | Author Veronika Petláková
The State Institute for Drug Control may, in cases referred to in the Act, waive the full amount of reimbursed costs or part of it. In justified cases it may also refund the reimbursed costs.
Information on the IBAN format
Whole Article Wednesday, 13. May 2009 | Author Veronika Petláková
Some interactive forms on SÚKL's website perform a check for the correctness of the completed account number which has to be in the IBAN format.
Marketing authorisation of pharmaceuticals
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Regulation of prices and reimbursements for pharmaceuticals
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Clinical trial on pharmaceuticals
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Surveillance over the manufacture of pharmaceuticals
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Quality defects and enforcement
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Pharmaceuticals - supply, sales and preparation
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Clinical trial on pharmaceuticals
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Specific Therapeutic Programmes
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Surveillance in the area of advertising
Whole Article Tuesday, 15. February 2011 | Author Veronika Petláková
Documents for pharmacovigilance branch
Whole Article Thursday, 30. December 2010 | Author Veronika Petláková
Confirmation of the Approval/Notification of Clinical Trial for the Customs Clearance
Whole Article Wednesday, 12. June 2019 | Author Veronika Petláková
Clinical trials on products containing genetically modified organisms
Whole Article Friday, 3. September 2004 | Author Veronika Petláková
Instructions for applicants concerning requirements of the Czech Ministry of the Environment.
Information for applicants
Whole Article Wednesday, 17. May 2006 | Author Veronika Petláková
Up-to-date information for applicants (e.g. sponsors, contact persons, CRO) submitting applications for approval of a clinical trial on products of the following nature: gene therapy medicinal products, somatic cell therapy medicinal products (including cells of xenogeneic origin) or medicinal products containing genetically modified organisms.
Information for sponsors - 10.7.2008
Whole Article Thursday, 10. July 2008 | Author Veronika Petláková
Information for sponsors on the import of pharmaceuticals containing narcotic drugs and psychotropic substances - update.
KLH-8
Whole Article Wednesday, 19. March 2008 | Author Veronika Petláková
Clinical trial protocol and protocol amendment(s).
KLH-10
Whole Article Wednesday, 19. March 2008 | Author Veronika Petláková
Terminology and principles of good clinical practice.
KLH-19 version 1
Whole Article Wednesday, 22. October 2008 | Author
Documents Required for Authorisation of a Clinical Trial on Pharmaceuticals – Requirements Governing the Pharmaceutical Part of the Dossier.
List of subjects from manufacturing of the medicinal products branch
Whole Article Wednesday, 29. December 2010 | Author Veronika Petláková
List of subjects from human tissues, cells and blood branch
Whole Article Wednesday, 29. December 2010 | Author Veronika Petláková