SUKL Bulletin 2/2014

SUKL Bulletin 2/2014 was published 18. 2. 2014  

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 2014
  • List of guidelines valid as of February 1, 2014
  • Outline of notifications on the use of non-authorised medicinal products in the month of January 2014
  • List of medicinal products whose authorisation for parallel import was granted in the month of January 2014
  • 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 2013 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the fourth quarter of 2013
  • Overview of data on basic activities of the Inspection Section in the fourth quarter of 2013
  • Overview of data on activities of the SÚKL in the area of medical devicesin the fourth quarter of 2013
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medicaldevices approved by SUKL in the fourth quarter of 2013
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of January 2014
  • 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 January 31, 2014
  • Revocations of marketing authorisations in the period from December 1, 2013 to December 31, 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