SUKL Bulletin 6/2011

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 May 2011
  • List of guidelines valid as of June 1, 2011
  • Additional information concerning Good Distribution Practice
  • Information on storage of medicinal products imported from third countries
  • State Institute for Drug Control takes part in European projects
  • SUKL informs about a workshop on regulation of advertising to be held on June 28, 2011
  • Outline of notifications on the use of non-authorised medicinal products in the month of May 2011
  • List of medicinal products whose authorisation for parallel import was granted in the month of May 2011
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto (Data on numbers ofvarious types of applications submitted monthly to SUKL)
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of May 2011
  • List of medicinal products whose marketing authorisation will expire in August 2011
  • List of medicinal products for which maximum price applies in the same amount as proposed by the applicant
  • as of May 31, 2011
  • Revocations of marketing authorisations in the period from March 17, 2011 to April 12, 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