SUKL Bulletin 12/2005

Contents of SUKL Bulletin 12/2005

  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of November 2005
  • Information on drug consumption
    • Team of authors: Drug consumption in the Czech Republic in the 3rd quarter of the year 2005  Comparison with the situation in the previous period is given. Figures are expressed in number of packages, Czech crowns and Defined Daily       Doses.
  • Pharmacopoeia activities
    • Announcement of texts of the Czech Pharmacopoeia becoming official standards
    • Announcement of texts of the European Pharmacopoeia becoming official standards in the Czech Republic
  • Information
    • Information for healthcare providers - potential risks of self-investigation of adverse incidents of medical devices This information is intended as a       recommendation for healthcare providers, to respect certain principles when conducting internal investigation of adverse incidents of medical devices.
    • Information on current legislation in the area of medical devices - amendment
    • Information on starches as excipients in medicinal products from the coeliac disease point of view
    • Outline of notifications on the use of non-authorised medicinal products in the month of November 2005 The information on evaluated notifications in       the month of November 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 November 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 November 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 November 2005
    • List of medicinal products whose marketing authorisation will expire in February 2006 The validity of marketing authorizations of the listed products will expire during February 2006 and the products will be marked 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 November 30, 2005.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from October 20, 2005 to November 16, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from November 1, 2005 to November, 30, 2005
    • List of specific therapeutic programmes approved in the period from November 1, 2005 to November 30, 2005