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SUKL Bulletin 6/2007

Contents of SUKL Bulletin 6/2007  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of May 2007
    • Important announcement on the withdrawal of a medical device
    • Important announcement on increased risk in use of medical devices
  • SÚKL guidelines
    • List of guidelines valid as of July 1, 2007
    • UST-31 version 1-Principles for identification of human medicinal products in the CR The revision of the guideline newly specifies and explains use of the medicinal products identification codes in the Czech Republic.
  • Information on drug consumption
    • Team of authors: Drug consumption in the Czech Republic in the 1st quarter of the year 2007 Comparison with the situation in the previous period is given.       Figures are expressed in number of packages, Czech crowns and Defined Daily Doses.
  • Pharmacy activities
    • Control of pharmacies in the year 2006 Out of the total number of 2.318 samples taken from pharmacies 11,2 % were found non-compliant in some parameters. The number of non-compliant samples from pharmacies continues to be relatively high, but since 2005 the quality of medicinal products and purified water prepared in pharmacies has slightly improved.
  • Information
    • Annual meeting of the Official Medicines Control Laboratories in Prague - report
    • Outline of notifications on the use of non-authorised medicinal products in the month of May 2007 The information on evaluated notifications in the month of May 2007, 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 May 2007.
    • 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 April 2007 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 manufacturers and distributors of pharmaceuticals in the CR approved in the month of May 2007
    • List of medicinal products whose marketing authorisation will expire in August 2007 The validity of marketing authorizations of the listed products will expire during August 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 May 31, 2007.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from April 26, 2007 to May 23, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from May 1, 2007 to May 31, 2007
    • List of specific therapeutic programmes approved in the period of May 1, 2007 to May 31, 2007