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Published aricles: 59


Questions regarding specific therapeutic programmes

Questions and answers.  


Can something similar happen in the Czech Republic?


Questions on specific products


Questions on clinical trials on human pharmaceuticals

Questions and answers from workshops for pharmacies held on April 8 and April 16 2010  


Questions on individual use of a non-authorised pharmaceutical


Periodic Safety Update Reports (PSURs)

   


List of reimbursed medicinal products - periodical update

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

Updated List of medicinal products and foods for special medical purposes with reimbursement from the public health insurance.  


Haemovigilance

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).  


CZECH PHARMACOPOEIA


Where you can find us


Payment of administrative fees

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


Information on progress of administrative procedures

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

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

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

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


Regulation of prices and reimbursements for pharmaceuticals


Pharmacovigilance


Clinical trial on pharmaceuticals


Surveillance over the manufacture of pharmaceuticals


Quality defects and enforcement


Pharmacovigilance


Quality defects


Pharmaceuticals - supply, sales and preparation


Medical devices


Clinical trial on pharmaceuticals


Specific Therapeutic Programmes


Surveillance in the area of advertising


Central Repository


Pharmacovigilance


Links SUKL


Contacts


Legislation and definitions


Guidelines and forms


Documents for pharmacovigilance branch


Clinical trials on products containing genetically modified organisms

Instructions for applicants concerning requirements of the Czech Ministry of the Environment.  


Information for applicants

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

Information for sponsors on the import of pharmaceuticals containing narcotic drugs and psychotropic substances - update.  


KLH-8

Clinical trial protocol and protocol amendment(s).    


KLH-9

Investigator's brochure.  


KLH-10

Terminology and principles of good clinical practice.    


VYR-17

Extension of time the batches of medicinal products manufactured before the approval of the change in registration.  


KLH-19 version 1

Documents Required for Authorisation of a Clinical Trial on Pharmaceuticals – Requirements Governing the Pharmaceutical Part of the Dossier.  


Clinical trials database

   


Reviews and evaluations


Related information


Pharmaceuticals - supply, sales and preparation


List of subjects from manufacturing of the medicinal products branch


List of subjects from human tissues, cells and blood branch