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SUKL Bulletin 9/2006

Contents of SUKL Bulletin 9/2006  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of August 2006
  • SÚKL guidelines
    • List of guidelines valid as of October 1, 2006
    • VYR-27 Version 1 - Application for an authorisation/change to authorisation for manufacture of medicinal products and guidance for provision of detailed information on manufacture New application forms for authorisation for       manufacture of medicinal products and for a change to that authorisation,       including Site Master File format as resulted from the amended legislation.
  • Information on drug consumption
    • Team of authors: Drug "consumption" in the Czech Republic in the 2nd quarter of  the year 2006 Comparison with the situation in the previous period is given. Figures are expressed in number of packages, Czech crowns and Defined Daily Doses.
  • Information
    • Screening of number of non-usable medicinal products returned to pharmacies in the CR
    • Information for blood service centres on the storage temperature and shelf life of fresh frozen plasma
    • Outline of notifications on the use of non-authorised medicinal products in the month of August 2006 The information on evaluated notifications in the month of August 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 August 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 July 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 August 2006
    • List of medicinal products whose marketing authorisation will expire in November 2006 The validity of marketing authorizations of the listed products will expire during November 2006 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 August 31, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from July 20, 2006 to August 23, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from August 1, 2006 to August 31, 2006
    • List of specific therapeutic programmes approved during the period of August 1, 2006 to August 31, 2006