SUKL Bulletin 10/2013

SUKL Bulletin 10/2013 was published 25. 10. 2013  

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 September 2013
  • List of guidelines valid as of October 1, 2013
  • Information for distributors on export of medicinal products abroad
  • Outline of notifications on the use of non-authorised medicinal products in the month of September 2013
  • List of medicinal products whose authorisation for parallel import was granted in the monthof September 2013
  • 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)
  • A list of new documents issued by the EMA in September 2013 is published. Documents are availablein SUKL library
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • Data on numbers of various types of applications submitted monthly to SUKL
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the monthof September 2013
  • 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 September 30, 2013
  • Revocations of marketing authorisations in the period from August 1, 2013 to August 31, 2013
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2013
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL databasein the year 2013