SUKL Bulletin 3/2006

Contents of SUKL Bulletin 3/2006  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of February 2006
  • Information on drug consumption
    • Team of authors: Drug "consumption" in the Czech Republic in the year 2005 This article is focused on drug "consumption" in the Czech Republic in the year       2005 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
    • Plan of seminars prepared by the State Institute for Drug Control in the 1st half of 2006
    • Information on conditions for running external courses intended to obtain education of qualified persons of manufacturers of medicinal products The information is intended for manufacturers of medicinal products seeking SÚKL´s or ÚSKVBL´s approval with qualified persons who do not have a university degree in pharmacy. This information is meant also for organizers who run courses aimed at providing professional education for qualified persons.
    • Outline of notifications on the use of non-authorised medicinal products in the month of January 2006 The information on evaluated notifications in the month of January 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 February 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 January 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 manufacturers and distributors of pharmaceuticals in the CR approved in the month of February 2006
    • List of medicinal products whose marketing authorisation will expire in May 2006 The validity of marketing authorizations of the listed products will expire during May 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 February 28, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of January 19, 2006 to February 22, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from February 1, 2006 to February 28, 2006
    • List of specific therapeutic programmes approved during the period of February 1, 2006 to February 28, 2006