SUKL Bulletin 8/2013

SUKL Bulletin 8/2013 was published 22. 8. 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 July 2013
  • List of guidelines valid as of August 1, 2013
  • Outline of notications on the use of non-authorised medicinal products in the month of July 2013
  • List of medicinal products whose authorisation for parallel import was granted in the month of July 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)
  • Alist of new documents issued by the EMA in June 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 second quarter of 2013 – department of clinical trials
  • Overview of data on basic activities of the Section of Pharmacy and Distribution Controlin the second quarter of 2013
  • Overview of data on basic activities of the Inspection Section in the second quarter of 2013
  • Overview of data on SUKL activities in the area of medical devices in the second quarter of 2013
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devicesapproved by SUKL in the second quarter of 2013
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of July 2013
  • List of medicinal products and foods for special medical purposes without determined reimbursement, forwhich maximum price applies in the same amount as proposed by the applicant as of July 31, 2013
  • Revocations of marketing authorisations in the period from June 1, 2013 to June 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