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SUKL Bulletin 11/2011

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

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 October 2011
  • List of guidelines valid as of November 1, 2011
  • Information of SUKL for healthcare professionals and pharmacies about reclassification of the legal status for supply (“switch” from POM to restricted sale OTC)
  • Outline of notifications on the use of non-authorised medicinal products in the month of October 2011
  • List of medicinal products whose authorisation for parallel import was granted in the month of October 2011
  • 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 third quarter of 2011 – clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Control in the third quarter of 2011
  • Overview of data on basic activities of the Inspection Section in the third quarter of 2011
  • Overview of data on activities of the Surveillance Branch in the area of medical devices in the third quarter of 2011
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2011
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2011
  • List of medicinal products whose marketing authorisation will expire in January 2012
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposed by the applicant as of October 31, 2011
  • Revocations of marketing authorisations in the period from August 11, 2011 to September 14, 2011
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2011
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2011