Published aricles: 40
List of reimbursed medicinal products valid as of 1.8.2013
Whole Article Wednesday, 31. July 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”).
SUKL Bulletin 6/2013
Whole Article Friday, 21. June 2013 | Author Lucie Šustková
SUKL Bulletin 6/2013 was published 21. 6. 2013
SUKL Bulletin 7/2013
Whole Article Thursday, 25. July 2013 | Author Lucie Šustková
SUKL Bulletin 7/2013 was published 25. 7. 2013
Annual Report 2011
Whole Article Wednesday, 26. September 2012 | Author Lucie Šustková
Annual Report of the SUKL activities in 2011
Annual Report 2012
Whole Article Wednesday, 24. July 2013 | Author Lucie Šustková
Annual Report of the SUKL activities in 2012
REG-90
Whole Article Wednesday, 24. July 2013 | Author
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
Whole Article Thursday, 18. July 2013 | Author MUDr. Tomáš Boráň
Current information for sponsors, contact persons, CRO, about the requirement to submit the Clinical Study Report to State Institute for Drug Control (hereinafter „Institute“).
In what format should the submitted documentation be since the Amendment to the Act on Pharmaceuticals? If documentation is not in the eCTD format, should an exemption still be applied for?
Whole Article Monday, 29. April 2013 | Author Petra Špimrová
Will the new procedure of processing applications affecting product information make it necessary to submit an application for a variation to marketing authorisation in case of a change to SPC, PIL and/or labelling?
Whole Article Monday, 29. April 2013 | Author Petra Špimrová
Which form can be used to apply for marketing authorisation of a homeopathic product with indications?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Does the amended Act on Pharmaceuticals allow the authorisation of homeopathic medicinal products with specified indications?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What change of conditions must take place in the case of an authorised herbal medicinal product so that Section 30 paragraph becomes applicable to it?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What change of conditions must take place in the case of an authorised herbal medicinal product so that Section 30 paragraph 9 becomes applicable to it?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Will the decisions on marketing authorisation of medicinal products be published on the Institute’s website?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
How will the obligation to submit regular safety update reports stipulated in the marketing authorisation?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
How should marketing authorisation holders present periodic safety update reports in the case of medicinal products authorised as generics, homeopathic products, traditional herbal products or based on literary data?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
How should the marketing authorisation holder apply for revocation of marketing authorisation pursuant to the amended Act on Pharmaceuticals?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What documentation has to be submitted together with the application for renewal of a marketing authorisation of a medicinal product authorised through the national procedure?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
When is it necessary to submit an application for renewal of the marketing authorisation of a medicinal product?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
How will be product information (SPC, PIL, labelling) labelled when being sent by post together with the decision (i.e. to natural persons without a data mailbox or to persons residing abroad)?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
How does the amended Act on Pharmaceuticals affect the handling of applications for marketing authorisation, applications for marketing authorisation renewal or variation and applications for permission of parallel import that involve the SPC, PIL and l
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What deadlines are stipulated by the amended Act on Pharmaceuticals for supplementing of information by the applicant where applications for marketing authorisation, applications for renewal of a marketing authorisation and type II variation applications
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What changes have been made concerning the documentation submitted when applying for a new marketing authorisation?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
List of reimbursed medicinal products valid as of 1.7.2013
Whole Article Friday, 28. June 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”).
List of reimbursed medicinal products valid as of 1.6.2013
Whole Article Friday, 31. May 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”).
List of reimbursed medicinal products valid as of 1.5.2013
Whole Article Tuesday, 30. April 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”).
Adverse Drug Reaction (ADR) reporting
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
PSUR – Periodic Safety Update Reports
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
PASS – Post-Authorisation Safety Studies
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
PSMF – Pharmacovigilance system master file and QPPV – Qualified person for pharmacovigilance
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
GVP – Good Pharmacovigilance Practices
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Questions and answers on the amended Act on Pharmaceuticals - marketing authorisations
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
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
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
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
Whole Article Monday, 8. April 2013 | Author Veronika Petláková
Pursuant to Section 8 (3) (b) (2)
Use of non-authorised medicinal products
Whole Article Monday, 8. April 2013 | Author Veronika Petláková
Questions and answers on the amended Act on Pharmaceuticals - clinical trials
Whole Article Monday, 8. April 2013 | Author Veronika Petláková
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.