SUKL Bulletin 7/2011

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 products in the month of June 2011
  • List of guidelines valid as of July 1, 2011
  • Drug distribution and dispensing in the Czech Republic in the 1st quarter of the year 2011
  • Decision on a result of the competition for the lowest price – ref. group 1/3
  • Decision on a result of the competition for the lowest price – ref. group 87/1
  • Decision on a result of the competition for the lowest price – ref. group 25/3
  • Announcement of texts of the European Pharmacopoeia becoming official standards
  • Outline of notifications on the use of non-authorised medicinal products in the month of June 2011
  • List of medicinal products whose authorisation for parallel import was granted in the month of June 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
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the second quarter of 2011
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of June 2011
  • List of medicinal products whose marketing authorisation will expire in September 2011
  • 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 June 30, 2011
  • Revocations of marketing authorisations in the period from April 21, 2011 to May 25, 2011
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2011
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL database in the year 2011