SUKL Bulletin 3/2007

Contents of SUKL Bulletin 3/2007  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of February 2007
    • Important announcement on the withdrawal of a medical device
  • SÚKL guidelines
    • List of guidelines valid as of April 1, 2007
    • DIS-13 version 2 - Reporting of deliveries of distributed medicinal products The second revision of the guideline defines more exactly the way of reporting       deliveries of medicinal products supplied by wholesalers or manufacturers to health care facilities or vendors of selected medicinal products and the structure of the report.
  • Information on drug consumption
    • Team of authors: Drug "consumption" in the Czech Republic in the year 2006 This article is focused on drug "consumption" in the Czech Republic in the year       2006 and on the comparison against previous years. Figures are given in the number of packages, Czech crowns and Defined Daily Doses. Consumption of several ATC groups with highest level of consumption is discussed.
  • Information
    • Annual meeting of the Official Medicines Control Laboratories in May 2007 in Prague - information
    • Project RAPSODY (Rare Disease Patient Solidarity) - information
    • Outline of notifications on the use of non-authorised medicinal products in the month of February 2007 The information on evaluated notifications in the month of February 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 February 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 January 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 February 2007
    • List of medicinal products whose marketing authorisation will expire in May 2007 The validity of marketing authorizations of the listed products will expire during May 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 marke by "Z" in SUKL database as of Febuary 28, 2007.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from January 25, 2007 to Febuary 21, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from Febuary 1, 2007 to Febuary 28, 2007
    • List of specific therapeutic programmes approved in the period of January 30, 2007 to Febuary 28, 2007