SUKL Bulletin 2/2013

SUKL Bulletin 2/2013 was published 12. 2. 2013  

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

Contents:

  • Information about quality defects or adverse reactions to medicinal products, counterfeit products,illegal products and medical devices in the month of January 2013
  • List of guidelines valid as of February 1, 2013
  • Outline of notifications on the use of non-authorised medicinal products in the month of January 2013
  • List of medicinal products whose authorisation for parallel import was granted in the monthof January 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
  • Overview of data on applications submitted in the fourth quarter of 2012 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the fourth quarter of 2012
  • Overview of data on basic activities of the Inspection Section in the fourth quarter of 2012
  • Overview of data on activities of the Surveillance Branch in the area of medical devicesin the fourth quarter of 2012
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medicaldevices approved by SUKL in the fourth quarter of 2012
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the monthof January 2013
  • List of medicinal products whose marketing authorisation will expire in April 2013
  • List of medicinal products with expired marketing authorisation
  • Revocations of marketing authorisations in the period from December 1, 2012 to December 31, 2012
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2012
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL databasein the year 2012