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SUKL Bulletin 12/2006

Contents of SUKL Bulletin 12/2006  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of November 2006
    • Important notice on withdrawal of a medical device
  • SÚKL guidelines
    • List of guidelines valid as of January 1, 2007
    • UST-25 Version 1 - Consultation procedure with SUKL staff Change in       procedure of consultations (consultation upon request and scientific       consultation upon request) is provided.
    • UST-29 Version 1 - Administration fees and costs reimbursement for activities performed on request Minor changes in the guideline UST-29 concern payment of administrations fees and costs reimbursement (in particular, payments in EUR will be accepted).
  • Information on drug consumption
    • Team of authors: Drug "consumption" in the Czech Republic in the 3rd 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
    • Information on seminars held by SUKL in the 1st half of 2007 The overview of seminars and the application form are included.
    • Outline of notifications on the use of non-authorised medicinal products in the month of November 2006 The information on evaluated notifications in the month of November 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 November 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 October 2006 is published. Documents are available in SUKL
    • 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 2006
    • List of medicinal products whose marketing authorisation will expire in February 2007 The validity of marketing authorizations of the listed products will expire during February 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 marked by "Z" in SUKL database as of November 30, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from October 26, 2006 to November 22, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from November 1, 2006 to November 30, 2006