Archive

There is an Archive of all articles sorted by date of publication.

2007    2008    2009    2010    2011    2012    2013    2014    2015    2016    2017    2018    2019    2020    2021   

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Published aricles: 151


SUKL Bulletin 1/2012

SUKL Bulletin 1/2012 was published 20. 1. 2012  


SUKL Bulletin 2/2012

SUKL Bulletin 2/2012 was published 24. 2. 2012  


SUKL Bulletin 3/2012

SUKL Bulletin 3/2012 was published 22. 3. 2012  


SUKL Bulletin 4/2012

SUKL Bulletin 4/2012 was published 26. 4. 2012  


SUKL Bulletin 5/2012

SUKL Bulletin 5/2012 was published 18. 5. 2012  


SUKL Bulletin 6/2012

SUKL Bulletin 6/2012 was published 19. 6. 2012  


SUKL Bulletin 7/2012

SUKL Bulletin 7/2012 was published 24. 7. 2012  


SUKL Bulletin 8/2012

SUKL Bulletin 8/2012 was published 21. 8. 2012  


SUKL Bulletin 2012


SUKL Bulletin 1/2011

SUKL Bulletin 1/2011 was published 20. 1. 2011  


SUKL Bulletin 2/2011

SUKL Bulletin 2/2011 was published 15. 2. 2011  


SUKL Bulletin 3/2011

SUKL Bulletin 3/2011 was published 17. 3. 2011  


SUKL Bulletin 4/2011

SUKL Bulletin 4/2011 was published 19. 4. 2011  


SUKL Bulletin 5/2011

SUKL Bulletin 5/2011 was published 20. 5. 2011  


SUKL Bulletin 6/2011

SUKL Bulletin 6/2011 was published 20. 6. 2011  


SUKL Bulletin 7/2011

SUKL Bulletin 7/2011 was published 28. 7. 2011  


SUKL Bulletin 8/2011

SUKL Bulletin 8/2011 was published 23. 8. 2011  


SUKL Bulletin 9/2011

SUKL Bulletin 9/2011 was published 20. 9. 2011  


SUKL Bulletin 10/2011

SUKL Bulletin 10/2011 was published 18. 10. 2011  


SUKL Bulletin 11/2011

SUKL Bulletin 11/2011 was published 22. 11. 2011  


SUKL Bulletin 12/2011

SUKL Bulletin 12/2011 was published 20. 12. 2011  


SUKL Bulletin 2011


SUKL Bulletin 1/2010

SUKL Bulletin 1/2010 was published 18. 1. 2010  


SUKL Bulletin 2/2010

SUKL Bulletin 2/2010 was published 15. 2. 2010  


SUKL Bulletin 3/2010

SUKL Bulletin 3/2010 was published 22. 3. 2010  


SUKL Bulletin 4/2010

SUKL Bulletin 4/2010 was published 15. 4. 2010  


SUKL Bulletin 5/2010

SUKL Bulletin 5/2010 was published 27. 5. 2010  


SUKL Bulletin 6/2010

SUKL Bulletin 6/2010 was published 18. 6. 2010  


SUKL Bulletin 7/2010

SUKL Bulletin 7/2010 was published 16. 7. 2010  


SUKL Bulletin 8/2010

SUKL Bulletin 8/2010 was published 17. 8. 2010  


SUKL Bulletin 9/2010

SUKL Bulletin 9/2010 was published 16. 9. 2010  


SUKL Bulletin 10/2010

SUKL Bulletin 10/2010 was published 14. 10. 2010  


SUKL Bulletin 11/2010

SUKL Bulletin 11/2010 was published 16. 11. 2010  


SUKL Bulletin 12/2010

SUKL Bulletin 12/2010 was published 16. 12. 2010  


SUKL Bulletin 2010


SUKL Bulletin 1/2009


SUKL Bulletin 2/2009


SUKL Bulletin 3/2009


SUKL Bulletin 4/2009

SUKL Bulletin 4/2009 was published 30. 4. 2009  


SUKL Bulletin 5/2009


SUKL Bulletin 6/2009

SUKL Bulletin 6/2009 was published 29. 6. 2009  


SUKL Bulletin 7/2009

SUKL Bulletin 7/2009 was published 17. 7. 2009  


SUKL Bulletin 8/2009

SUKL Bulletin 8/2009 was published 24. 8. 2009  


SUKL Bulletin 9/2009

SUKL Bulletin 9/2009 was published 17. 9. 2009  


SUKL Bulletin - Extraordinary edition

SUKL Bulletin - Extraordinary edition was published 5. 10. 2009  


SUKL Bulletin 10/2009

SUKL Bulletin 10/2009 was published 20. 10. 2009  


SUKL Bulletin - Extraordinary edition

SUKL Bulletin - Extraordinary edition was published 21. 10. 2009  


SUKL Bulletin 11/2009

SUKL Bulletin 11/2009 was published 13. 11. 2009  


SUKL Bulletin 2009


SUKL Bulletin 12/2009

SUKL Bulletin 12/2009 was published 17. 12. 2009  


SUKL Bulletin 1/2008

Contents of SUKL Bulletin 1/2008  


SUKL Bulletin 2/2008

Contents of SUKL Bulletin 2/2008  


SUKL Bulletin 3/2008

Contents of SUKL Bulletin 3/2008  


SUKL Bulletin 4/2008

Contents of SUKL Bulletin 4/2008  


SUKL Bulletin 5/2008

Contents of SUKL Bulletin 5/2008  


SUKL Bulletin 6/2008

Contents of SUKL Bulletin 6/2008  


SUKL Bulletin 7/2008

Contents of SUKL Bulletin 7/2008  


SUKL Bulletin 8/2008

Contents of SUKL Bulletin 8/2008  


SUKL Bulletin 9/2008

Contents of SUKL Bulletin 9/2008  


SUKL Bulletin 10/2008

Contents of SUKL Bulletin 10/2008  


SUKL Bulletin 11/2008

Contents of SUKL Bulletin 11/2008  


SUKL Bulletin 12/2008

Contents of SUKL Bulletin 12/2008  


SUKL Bulletin 1/2007

Contents of SUKL Bulletin 1/2007  


SUKL Bulletin 2/2007

Contents of SUKL Bulletin 2/2007  


SUKL Bulletin 3/2007

Contents of SUKL Bulletin 3/2007  


SUKL Bulletin 4/2007

Contents of SUKL Bulletin 4/2007  


SUKL Bulletin 5/2007

Contents of SUKL Bulletin 5/2007  


SUKL Bulletin 6/2007

Contents of SUKL Bulletin 6/2007  


SUKL Bulletin 7/2007

Contents of SUKL Bulletin 7/2007  


SUKL Bulletin 8/2007

Contents of SUKL Bulletin 8/2007  


SUKL Bulletin 9/2007

Contents of SUKL Bulletin 9/2007  


SUKL Bulletin 10/2007

Contents of SUKL Bulletin 10/2007  


SUKL Bulletin 11/2007

Contents of SUKL Bulletin 11/2007  


SUKL Bulletin 12/2007

Contents of SUKL Bulletin 12/2007  


SUKL Bulletin 1/2006

Contents of SUKL Bulletin 1/2006  


SUKL Bulletin 2/2006

Contents of SUKL Bulletin 2/2006  


SUKL Bulletin 3/2006

Contents of SUKL Bulletin 3/2006  


SUKL Bulletin 4/2006

Contents of SUKL Bulletin 4/2006  


SUKL Bulletin 5/2006

Contents of SUKL Bulletin 5/2006  


SUKL Bulletin 8/2006

Contents of SUKL Bulletin 8/2006  


SUKL Bulletin 9/2006

Contents of SUKL Bulletin 9/2006  


SUKL Bulletin 10/2006

Contents of SUKL Bulletin 10/2006  


SUKL Bulletin 11/2006

Contents of SUKL Bulletin 11/2006  


SUKL Bulletin 12/2006

Contents of SUKL Bulletin 12/2006  


SUKL Bulletin 1/2005

Contents of SUKL Bulletin 1/2005  


SUKL Bulletin 2/2005

Contents of SUKL Bulletin 2/2005  


SUKL Bulletin 3/2005

Contents of SUKL Bulletin 3/2005  


SUKL Bulletin 4/2005

Contents of SUKL Bulletin 4/2005  


SUKL Bulletin 5/2005

Contents of SUKL Bulletin 5/2005  


SUKL Bulletin 6/2005

Contents of SUKL Bulletin 6/2005  


SUKL Bulletin 7/2005

Contents of SUKL Bulletin 7/2005  


SUKL Bulletin 8/2005

Contents of SUKL Bulletin 8/2005  


SUKL Bulletin 9/2005

Contents of SUKL Bulletin 9/2005  


SUKL Bulletin 10/2005

Contents of SUKL Bulletin 10/2005  


SUKL Bulletin 11/2005

Contents of SUKL Bulletin 11/2005  


SUKL Bulletin 12/2005

Contents of SUKL Bulletin 12/2005  


Borderline products


Quality defects and enforcement


Specific Therapeutic Programmes


Laboratory activities and pharmacopoeias


Distribution of pharmaceuticals


Form I


Form II.


Incident Final Report Form


Incident Initial Report Form


Form CI AIMD

Clinical Investigation Notification Form.  


Form CI MD

Clinical Investigation Notification Form.      


Annual Report 2004

Annual Report of the SUKL activities in 2004  


Annual Report 1998

Annual Report of the SUKL activities in 1998  


Annual Report 1999

Annual Report of the SUKL activities in 1999  


Annual Report 2000

Annual Report of the SUKL activities in 2000  


Annual Report 2001

Annual Report of the SUKL activities in 2001.  


Annual Report 2002

Annual Report of the SUKL activities in 2002.  


Annual Report 2003

Annual Report of the SUKL activities in 2003  


Annual Report 2005

Annual Report of the SUKL activities in 2005  


Annual Report 2006

Annual Report of the SUKL activities in 2006  


Annual Report 2007

Annual Report of the SUKL activities in 2007  


Annual Report 2008

Annual Report of the SUKL activities in 2008  


Annual Report 2009

Annual Report of the SUKL activities in 2009  


Annual Report 2010

Annual Report of the SUKL activities in 2010  


Guidelines and Forms


Ethics Committee established at healthcare facilities


Ethics Committees for Multicentric Clinical Trials


Guidelines and Forms


Ethics Committees for Multicentric Clinical Trials

In compliance with Section 54 of Act No 378/2007 Coll. on Amendment to the Act on Pharmaceuticals and on Amendments to Other Acts, applications for opinions on multicentric clinical trials are also submitted to the following Multicentric Ethics Committees.  


Ethics Committee established at healthcare facilities

List of Ethics Committee established at healthcare facilities    


Ethic Committies


Producer Price Notification Form


Details of distribution of pharmaceuticals


Annual maintenance fee


Information of the Administrative Procedure Code


Powers of Attorney


Data mailbox information system

Information on SÚKL's data mailbox communication.  


Course of the advice


Reimbursement of costs for advice provision


Other branches - How to process when applying for an advice


UST-35 version 2

Non-interventional Post-authorisation Studies, Method of Reporting  


Contacts

   


Contacts


REG-46 version 1

Maximum shelf-life for sterile products after first opening or after reconstitution.  


Details of marketing authorisation


May foodstuffs intended for particular nutritional uses contain also substances which are not listed in Annex 13 to Decree No 54/2004 Coll.?

Yes, but the assessment and authorisation of foodstuffs intended for particular nutritional uses is not within the powers of SÚKL and it is necessary to contact the Ministry of Health of the Czech Republic, department of Public Health Protection.  


Who and how authorises foodstuffs intended for particular nutritional uses in the Czech Republic?

The regulation of foodstuffs intended for particular nutritional uses falls within the powers of the Ministry of Health of the Czech Republic and the Czech Agriculture and Food Inspection Authority (CAFIA).  


Who and how approves dietary supplements in the Czech Republic?

The regulation of dietary supplements falls within the powers of the Ministry of Health of the Czech Republic.  


Is it possible to use the same substances which are contained in an authorised medicinal product, also in foodstuffs intended for particular nutritional uses or in dietary supplements?

Annex 13 of Decree No 54/2004 Coll. defines a list of substances which may be added to foodstuffs intended for particular nutritional uses.  


How are cosmetic products regulated in the Czech Republic?

The regulation of cosmetic products is governed by Act No 258/2000 Coll., on the Protection of Public Health and Amendments to Some Related Acts, as amended (Section 25 - Section 29), and Decree No 26/2001 Coll. on hygienic requirements governing cosmetic products, as amended.  


What is the difference between dietary supplements and over-the-counter medicinal products?

It is often difficult for the consumer to navigate in the deluge of products available in pharmacies as “over-the-counter” (OTC) products, and, in particular, distinguish the two basic types of these products – dietary supplements and medicinal products - with confidence.  


What are foodstuffs intended for particular nutritional uses?

Foodstuffs intended for particular nutritional uses are defined by Decree No 54/2004 Coll.,   on foodstuffs intended for particular nutritional uses and on the method of their use, as amended.  


UST-19 version 4

Application for a decision whether a product is classified as a medicinal product  


Correction of the List of reimbursed medicinal products valid as of 3.8.2012

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”) in a new data interface version that reflects the changes ensuing from Act No. 298/2011 Coll. In light of the foregoing, ordinary updates of the List will no longer be published.  


List of reimbursed medicinal products valid as of 1.8.2012

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”) in a new data interface version that reflects the changes ensuing from Act No. 298/2011 Coll. In light of the foregoing, ordinary updates of the List will no longer be published.