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SUKL Bulletin 5/2007

Contents of SUKL Bulletin 5/2007  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of April 2007
  • Information
    • Supervision over advertising of medicinal products in 2006 Numbers of       investigated cases of reports on breaches of legal regulations were published together with solutions set up.
    • SUKL information for control laboratories providing microbiological testing of non-sterile products SUKL issues additional information regarding technical aspects of microbiological testing of non-sterile products including specifications of related activities.
    • Outline of notifications on the use of non-authorised medicinal products in the month of April 2007 The information on evaluated notifications in the month of April 2007, 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 April 2007
    • 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 March 2007 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the first quarter of 2007
    • Overview of data on basic activities of the Inspection Branch in the first quarter of 2007
    • Overview of data on activities of the Medical Devices Branch in the first quarter of 2007
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of April 2007
    • List of medicinal products whose marketing authorisation will expire in July 2007 The validity of marketing authorizations of the listed products will expire during July 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 April 30, 2007.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from March 22, 2007 to April 25, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from April 1, 2007 to April 30, 2007
    • List of specific therapeutic programmes approved in the period of April 1, 2007 to April 30, 2007