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SUKL Bulletin 5/2013

SUKL Bulletin 5/2013 was published 21. 5. 2013  

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 April 2013
  • List of guidelines valid as of May 1, 2013
  • Outline of notifications on the use of non-authorised medicinal products in the month of April 2013
  • 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 first quarter of 2013 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the first quarter of 2013
  • Overview of data on basic activities of the Inspection Section in the first quarter of 2013
  • Overview of data on SUKL activities in the area of medical devices in the first quarter of 2013
  • List of new pharmacies and separate departments for dispensing pharmaceuticalsand medical devices approved by SUKL in the first quarter of 2013
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of April 2013
  • 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 April 30, 2013
  • Revocations of marketing authorisations in the period from March 1, 2013 to March 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