SUKL Bulletin 2/2012

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 January 2012
  • List of guidelines valid as of February 1, 2012
  • Change in guidelines for filling in application forms for price and reimbursement
  • Outline of notifications on the use of non-authorised medicinal productsin the month of January 2012
  • List of medicinal products whose authorisation for parallel import was grantedin the month of January 2012
  • Information on Czech standards relating to medical devices publishedin 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 quarterof 2011 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the fourth quarter of 2011
  • Overview of data on basic activities of the Inspection Section in the fourth quarter of 2011
  • Overview of data on activities of the Surveillance Branch in the area of medical devicesin the fourth quarter of 2011
  • List of new pharmacies and separate departments for dispensing pharmaceuticalsand medical devices approved by SUKL in the fourth quarter of 2011
  • List of manufacturers and distributors of pharmaceuticals in the CR approvedin the month of January 2012
  • List of medicinal products whose marketing authorisation will expire in April 2012
  • List of medicinal products and foods for special medical purposes without determinedreimbursement, for which maximum price applies in the same amount as proposedby the applicant as of January 31, 2012
  • Revocations of marketing authorisations in the period from December 2, 2011 to December 31, 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 databasein the year 2011