SUKL Bulletin 1/2009

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

Contents:

  • Measures taken in the case of quality defects or adverse reactions to medicinal productsin the month of December 2008
  • List of guidelines valid as of January 1, 2009
  • Information on changes of the contents of Věstník SUKL
  • Information for pharmacies on launch of Central Repository
  • Information about issued technical documents
  • Outline of notifications on the use of non-authorised medicinal products in the month of December 2008
  • List of authorised medicinal products where placing on the market of individual batcheswith the labelling in a foreign language was approved in the month of December 2008
  • List of medicinal products whose authorisation for parallel import was grantedin the month of December 2008
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Data on applications submitted to SUKL –marketing authorisations and variations theretoData on numbers of various types of applications submitted monthly to SUKL
  • List of new pharmacies and detached departments for dispensing pharmaceuticalsand medical devices approved by SUKL in the fourth quarter of 2008
  • List of manufacturers and distributors of pharmaceuticals in the CR approvedin the month of December 2008
  • List of medicinal products whose marketing authorisation will expire in March 2009The validity of marketing authorisations of the listed products will expireduring March 2009 and the products will be marked in SUKL database by „Z“ and published in Věstník SÚKL
  • List of medicinal products with expired marketing authorisationThe listed products are marked by „Z“ in SUKL database as of December 31, 2008
  • Revocations of marketing authorisations in the period from December 1, 2008 to December 31, 2008
  • List of specific therapeutic programmes approvedin the period from December 1, 2008 to December 31, 2008