SUKL Bulletin 5/2015

SUKL Bulletin 5/2015 was published 27. 5. 2015  

Since 2009 SUKL Bulletin is published in electronic form. Full version is available on the czech webpage.


  • Information about quality defects or adverse reactions to medicinal products, counterfeit products,illegal products and medical devices in the month of April 2015
  • List of guidelines valid as of May 1, 2015
  • Outline of notifications on the use of non-authorised medicinal products in the month of April 2014
  • List of medicinal products whose authorisation for parallel import was granted in the monthof April 2014
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Information on documents issued by the European Medicines Agency (EMA)
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • Overview of data on applications submitted in the first quarter of 2015 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Control in the first quarter of 2015
  • Overview of data on basic activities of the Inspection Section in the fourth quarter of 2014 17
  • Overview of data on activities of the Medical Devices Branch in the first quarter of 2015
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the first quarter of 2015
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of April 2015
  • List of medicinal products and foods for special medical purposes without determined reimbursement, forwhich maximum price applies in the same amount as proposed by the applicant as of April 30, 2015
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2015
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL databasein the year 2015
  • Revocations of marketing authorisations in the year 2015