SUKL Bulletin 10/2009

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 September 2009
  • List of guidelines valid as of October 1, 2009
  • Determination of properties of OTC medicinal products
  • Information to changes of secondary packaging of medicinal products („repackaging„)
  • Outline of notifications on the use of non-authorised medicinal products in the month of September 2009
  • List of authorised medicinal products where placing on the market of individual batches with the labelling in a foreign language was approved in the month of September 2009
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Information on documents issued by the European Medicines Agency (EMEA)
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • List of new pharmacies and detached departments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2009
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of September 2009
  • List of medicinal products whose marketing authorisation will expire in December 2009
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposed by the applicant as of September 30, 2009
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2009
  • Medicinal products authorised under the EU centralised procedure and entered in SUKL database in the year 2009
  • List of specific therapeutic programmes approved in the period from September 1, 2009 to September 30, 2009