SUKL Bulletin 3/2005

Contents of SUKL Bulletin 3/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of February 2005
  • SÚKL quidelines
    • List of guidelines valid as of April 1, 2005
    • PHV-4-Electronic Reporting of Adverse Drug Reactions
  • Information on drug consumption
    • Team of authors: Drug "consumption" in the Czech Republic in the year 2004 This article is focused on drug "consumption" in the Czech Republic in the year       2004 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
    • Information for Marketing Authorisation Holders on reporting of EAN codes Since January 1, 2004, there is a legal requirement for all medicinal products to be  labelled with EAN codes. The MA holders should fulfil this duty and inform SUKL about EAN codes of their medicinal products. Authorised products released for circulation after 1 st January 2005 without being marked with the EAN code or those marked with a code different from that in SUKL records shall be considered defective and appropriate action will be taken.
    • Outline of notifications on the use of non-registered medicinal products in the month of February 2005 The information on evaluated notifications in the month of February 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 February 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 February 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 manufacturers and distributors of pharmaceuticals in the CR approved in the month of February 2005
    • List of medicinal products whose marketing authorisation will expire in May 2005 The validity of marketing authorizations of the listed products will expire during May 2005 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 indicated by "Z" in SUKL database as of February 28, 2005.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of January 27, 2005 to February 23, 2005
    • List of specific therapeutic programmes approved during the period of January 27, 2005 to February 28, 2005