SUKL Bulletin 11/2012

SUKL Bulletin 11/2012 was published 20. 11. 2012  

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 October 2012
  • List of guidelines valid as of November 1, 2012
  • Outline of notifications on the use of non-authorised medicinal products in the month of October 2012
  • List of medicinal products whose authorisation for parallel import was granted in the month of October 2012
  • 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 2012 – clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Control in the third quarter of 2012
  • Overview of data on basic activities of the Inspection Section in the third quarter of 2012
  • Overview of data on activities of the Surveillance Branch in the area of medical devices in the third quarter of 2012
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2012
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2012
  • List of medicinal products whose marketing authorisation will expire in January 2013
  • List of medicinal products and foods for special medical purposes without determined reimbursement, for which maximum price applies in the same amount as proposed by the applicant as of October 31, 2012
  • Revocations of marketing authorisations in the period from September 1, 2012 to September 30, 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 database in the year 2012