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SUKL Bulletin 1/2006

Contents of SUKL Bulletin 1/2006  


  • Contents
  • PF 2006
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of December 2005
    • Announcement concerning medical devices
  • SÚKL quidelines
    • List of guidelines valid as of February 1, 2006
    • DIS-15-Monitoring and control of storage and transportation temperatures for pharmaceuticals This guideline replaces DIS-7 and determines additional standards to complete basic requirements which are specified in SÚKL guideline DIS-11. Detailed procedures recommended for monitoring and control of storage and transportation temperatures of pharmaceuticals are described.
  • Information
    • Information for pharmacies regarding other than standard ways of obtaining non-authorised medicinal products (e.g. from pharmacies in other EU Member  states)
    • Information for healthcare facilities concerning preparation of injectable cytostatics
    • Outline of notifications on the use of non-authorised medicinal products in the month of December 2005 The information on evaluated notifications in the month of December 2005, 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 2005
    • 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 December 2005 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 2005
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of December 2005
    • List of medicinal products whose marketing authorisation will expire in March 2006 The validity of marketing authorizations of the listed products will expire during March 2006 and the products will be indicated in SUKL database by "Z" and published in Věstník SÚKL.
    • List of medicinal products with expired validity of the registration decision The listed products are indicated by "Z" in SUKL database as of December 31, 2005.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of November 17, 2005 to December 14, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from December 1, 2005 to December 31, 2005
    • List of specific therapeutic programmes approved during the period of December 1, 2005 to December 31, 2005