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SUKL Bulletin 1/2007

Contents of SUKL Bulletin 1/2007  


  • Contents
  • PF 2007
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of December 2006
  • Pharmacy activities
    • Survey on the extent of preparation of medicinal products in Czech pharmacies The survey was conducted by e-mail messages sent to 1 748 pharmacies, answers were  received from 766 pharmacies (32,8 % of the overall number of pharmacies).
  • Information
    • Outline of notifications on the use of non-authorised medicinal products in the month of December 2006 The information on evaluated notifications in the month of December 2006, in particular numbers of notifications, patients, health care facilities and used medicinal products is published.
    • 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 December 2006
    • 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) A list of new documents issued by the EMEA in November 2006 is published. Documents are available in SUKL library.
    • Data on applications submitted to SUKL Data on numbers of various types of applications submitted monthly to SUKL.
    • List of new pharmacies and detached departments for dispensing pharmaceuticals and medical devices approved by SUKL in the fourth quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of December 2006
    • List of medicinal products whose marketing authorisation will expire in March 2007 The validity of marketing authorizations of the listed products will expire during March 2007 and the products will be indicated in SUKL database by "Z" and published in Věstník SÚKL.
    • List of medicinal products with expired marketing authorisation The listed       products are marked by "Z" in SUKL database as of December 31, 2006.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from November 23, 2006 to December 20, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from December 1, 2006 to December 31, 2006
    • List of specific therapeutic programmes approved in the period of November 1, 2006 to December 31, 2006