SUKL Bulletin 1/2014

SUKL Bulletin 1/2014 was published 21. 1. 2014  

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 December 2013
  • List of guidelines valid as of January 1, 2014
  • Information for manufacturing authorization holders concerning implementation of conclusionsof the paediatric worksharing
  • Outline of notifications on the use of non-authorised medicinal products in the month of December 2013
  • List of medicinal products whose authorisation for parallel import was granted in the monthof December 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)
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the monthof December 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 December 31, 2013
  • Revocations of marketing authorisations in the period from November 1, 2013 to November 30, 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