SUKL Bulletin 11/2013

SUKL Bulletin 11/2013 was published 19. 11. 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 productsand medical devices in the month of October 2013
  • List of guidelines valid as of November 1, 2013
  • Outline of notifications on the use of non-authorised medicinal products in the month of October 2013
  • List of medicinal products whose authorisation for parallel import was granted in the month of October 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)
  • A list of new documents issued by the EMA in October 2013 is published
  • Documents are available in SUKL library
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • Data on numbers of various types of applications submitted monthly to SUKL
  • Overview of data on applications submitted in the third quarter of 2013 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the third quarter of 2013
  • Overview of data on basic activities of the Inspection Section in the third quarter of 2013
  • Overview of data on SUKL activities in the area of medical devices in the third quarter of 2013
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2013
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2013
  • 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 October 31, 2013
  • Revocations of marketing authorisations in the period from September 1, 2013 to September 30, 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