SUKL Bulletin 3/2014

SUKL Bulletin 3/2014 was published 24. 3. 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 February 2014
  • List of guidelines valid as of March 1, 2014
  • Inspections aimed at handling of dependency-producing substances in pharmacies in the year 2013
  • Outline of notifications on the use of non-authorised medicinal products in the month of February 2014
  • List of medicinal products whose authorisation for parallel import was grantedin the month of February 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
  • List of manufacturers and distributors of pharmaceuticals in the CR approvedin the month of February 2014
  • 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 February 28, 2014
  • Revocations of marketing authorisations in the period from January 1, 2014 to January 31, 2014
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2014
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2014